search
Back to results

Robotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients.

Primary Purpose

Osteoarthritis, Knee, Osteoarthritis, Hip, Gait Disorders in Old Age

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Technological Rehabilitation
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Rehabilitation, Technology, Balance

Eligibility Criteria

55 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age greater than or equal to 55 years;
  • Patients with outcomes of surgery for prosthetic hip or knee replacement;
  • Latency from the acute event between 15 days and 3 months;
  • Cognitive abilities to execute simple orders and understand the physical therapist's directions [assessed by Token Test (score ≥26.5)];
  • Ability to walk independently or with little assistance;
  • Ability to understand and sign informed consent.

Exclusion Criteria:

  • Presence of systemic, neurological, cardiac pathologies that make walking hazardous or cause motor deficits;
  • Presence of oncological pathologies;
  • Presence of plantar ulcers;
  • Partial or total amputation of foot segments.

Sites / Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: Technological Group

No Intervention: Control Group

Arm Description

Technological group (TG) patients will undergo robotic treatment for the improvement balance through the robotic platform (Hunova® Movendo Technology srl, Genova, IT), 3 times per week for 45 minutes each, in addition to the conventional treatment (total 180 minutes per day). In particular, the technological rehabilitation performed employing a footboard will be mostly aimed at improving the balance both in sitting and standing position, and will be proposed static and dynamic exercises, exercises dual-task exercises, and exercises to improve trunk control.

Congrol Group (CG) patients will undergo conventional rehabilitation treatment only, using the main rehabilitation methods (e.g., neurocognitive theory, Bobath Concept, Progressive neuromuscular facilitation, etc.).

Outcomes

Primary Outcome Measures

Berg Balance Scale (BBS)
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.

Secondary Outcome Measures

Motricity Index (MI)
The Motricity Index can be used to assess the motor impairment in a patient who has had a stroke. Test for each leg: (1) ankle dorsiflexion with foot in a plantar flexed position 14 points are given if there is less than a full range of dorsiflexion (2) knee extension with the foot unsupported and the knee at 90° 14 points are given for less than 50% of full extension 19 points are given for full extension yet it can be easily pushed down (3) hip flexion with the hip bent at 90° moving the knee towards the chin 14 points are given if there is less than a full range of passive motion 19 points are given if the hip is fully flexed yet it can be easily pushed down. Interpretation: minimum score: 0 maximum score: 100
Timed Up and Go Test (TUG)
The Timed Up and Go test (TUG) measures in seconds the time it takes a subject to rise from a chair, walk a distance of 3 meters, turn, walk back to the chair and sit down. The performance is rated on a scale of 1 to 5 (where 1 is normal and 5 is severely abnormal) according to the observer's perception of the patient's risk of falling. The timed part of the test records the mean time (in seconds) from initial getting up to re-seating. Patients are compared with the mean time of adults in their age group, 60 to 69, 70 to 79, and 80 to 99 years of age.
Knee Injury and Osteoarthritis Outcome Score - Italian Version (KOOS-I)
KOOS-I is a self-administered questionnaire of 42 items and 5 sub-scales investigating different aspects: Symptoms (7 items, 2 inherent to stiffness); Pain (9 items); Functions and activities of daily living (17 items); Sports and recreation (5 items); and Quality of life in relation to the knee (4 items). All Scale Items present the same response mode by making use of a 5-point Likert scale ranging from 0 (no problems or difficulties) to 4 (high problems or difficulties).
Hip disability and Osteoarthritis Outcome Score - Italian version (HOOS-I)
HOOS-I is a self-administered questionnaire designed to assess reported symptoms at the hip joint level in subjects with or without primary osteoarthritis and following hip arthroplasty surgery. HOOS-I consists of 40 items divided into 5 subscales that assess five distinct dimensions relevant to the patient: Symptoms (3 items on symptoms and 2 on stiffness); Pain (10 items); Activities of Daily Living (ADL) (17 items); Physical function, sports and leisure activities (4 items); Quality of life (4 items). The patient has to express his/her opinion through standardized response options based on the 5-point Likert scale (none, mild, moderate, severe, extreme); each response is assigned a score ranging from 0 (no problem) to 4 (extreme problems).
Ambulation Index (AI)
The Ambulation Index is a rating scale to assess mobility by evaluating the time and degree of assistance required to walk 8 meters. Scores range from 0 (asymptomatic and fully active) to 10 (bedridden). The patient is asked to walk a marked 8 meters course as quickly and safely as possible. The examiner records the time and type of assistance (e.g., cane, walker, crutches) needed. Although the patient's walking is timed, the time is not used directly but is utilized in conjunction with other factors to rate the patient on an ordinal scale with 11 gradations. 0 = Asymptomatic; fully active. 10 = Bedridden
Walking handicap scale (WHS)
The Walking handicap scale (WHS) is an assessment tool that allows us to evaluate the quality of walking in the home and social environment through a a scale comprising six categories. 1 = Physiological walking: walking only as exercise 6 = Unrestricted walking in social settings: independent in all activities, on uneven ground, in crowded places, shows complete independence in public places
Functional Ambulation Classification (FAC)
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. To use the FAC, an assessor asks the subject various questions and briefly observes their walking ability to provide a rating from 0 to 5. A score of 0 indicates that the patient is a non-functional ambulator (cannot walk); A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3). A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score).
10 Meter Walk Test (10mWT)
The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance. The total time taken to ambulate 6 meters (m) is recorded to the nearest hundredth of a second. 6 m is then divided by the total time (in seconds) taken to ambulate and recorded in m/s. The time is measured for the middle 6 m to allow for patient acceleration and deceleration. The time is started when any part of the leading foot crosses the plane of the 2-m mark. The time is stopped when any part of the leading foot crosses the plane of the 8-m mark.1 The time to walk the middle 6m, the level of assistance, and type of assistive device and/or bracing used will be documented. If a patient requires total assistance or is unable to ambulate at all, a score of 0 m/s will be documented.
Six-Minute Walk test (6MWT)
The six-minute walk test (6MWT) is a sub-maximal exercise test used to assess walking endurance and aerobic capacity. Participants will walk around the perimeter of a set circuit for a total of six minutes. The score of the test is the distance a patient walks in 6 minutes (measured in meters and can round to the nearest decimal point). Distance (in meters) covered in six minutes is calculated by multiplying the number of total laps by 12 meters and adding the distance of the partial lap completed at the time the test ended.
Modified Barthel Index (mBI)
The modified Barthel Index (mBI) for activities of daily living is meant to be used in the assessment of patient performance (or degree of assistance required) with respect to self-care, sphincter management, transfers and locomotion. The index consist of 10 items (each scored with a number of points) that relate to activities of daily living (ADLs) where the final score is calculated by summing the points awarded to each item. A five-point rating scales for each item to improve sensitivity to detecting change. The 10 items assessed relate to help needed with feeding, bathing, grooming, dressing, transfers, walking, climbing stairs, presence or absence of fecal incontinence and urinary incontinence. The score ranges from 0 (maximum dependence) to 100 (maximum independence)
EuroQol- 5 Dimension (EQ-5D)
EQ-5D is an instrument which evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ- 5D index an utility scores anchored at 0 for death and 1 for perfect health.
Modified Fatigue Impact Scale (MFIS)
The Modified Fatigue Impact Scale (MFIS) is an instrument that provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items while the abbreviated version has 5 items. The MFIS is a structured, self-report questionnaire that the patient can generally complete with little or no intervention from an interviewer. However, patients with visual or upper extremity impairments may need to have the MFIS administered as an interview. Interviewers should be trained in basic interviewing skills and in the use of this instrument. The total score for the MFIS is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items.
Fatigue Scale for Motor and Cognitive Function (FSMC)
The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue). Two subscales (mental and physical fatigue) can be made. Items included in the subscale mental are 1-4-7-8-11-13-15-17-18-20 and items included in the subscale physical are 2-3-5-6-9-10-12-14-16-19.
Frontal Assessment Battery (FAB)
The FAB is a brief tool that can be used at the bedside or in a clinic setting to assist in discriminating between dementias with a frontal dysexecutive phenotype and Dementia of Alzheimer"s Type (DAT). The FAB has validity in distinguishing Fronto-temporal type dementia from DAT in mildly demented patients (MMSE > 24). Total score is from a maximum of 18, higher scores indicating better performance.
Trial Making Test (TMT)
The Trail Making Test (TMT) measures flexibility of thinking on a visual-motor sequencing task. It consists of two parts, A and B, where 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Trail A: Average 29 seconds, Deficient > 78 seconds, Rule of Thumb Most in 90 seconds Trail B: Average 75 seconds, Deficient > 273 seconds, Rule of Thumb Most in 3 minutes
Stroop Colour Word Test (SCWT)
The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. The subject is asked to read the words in the first task, to name colors in the second and third tasks. It is necessary to mark both any mistakes made but also the time spent on each task. The cut-off for the error interference effect is 4.24, while the cut-off for the time interference effect is 36.92.
Cancellation Test of Digit (CTD)
In the Cancellation Test of Digits (CTD) the patient is asked to cross out with a pencil, as quickly as possible, all numbers corresponding to those indicated at the top of each matrix. Line A serves as an example. The performance of the subject is counted from line I. Corrections of the barriers are not allowed. The task of the examiner is mark the point at which the subject has exceeded the maximum time of the test, but let the subject let the subject finish his task for each matrix. The maximum time for each matrix is 45 sec- and is considered from the moment the subject finishes the run in. If the subject takes less time than the maximum time, it will be indicated at the end of each matrix. The time cut-off for the test is 23.9.

Full Information

First Posted
July 13, 2022
Last Updated
August 1, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
search

1. Study Identification

Unique Protocol Identification Number
NCT05459584
Brief Title
Robotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients.
Official Title
RObotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients: Effects on Functional, Motor, and Cognitive Outcomes.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Osteoarthritis is a chronic, degenerative disease affecting the joints. It is characterized by the presence of bone tissue that goes to make up for the loss of articular cartilage, causing pain and limitation of movement. Osteoarthritis is a direct consequence of aging: it affects almost all 70-year-olds, peaking between 75 and 79 years. The presence of osteoarthritic processes at the hip and knee joints can result in pain, difficulty maintaining standing for a long time, and difficulty walking with loss of balance, increasing the risk of accidental falls to the ground. Falls are a frequent cause of mortality and morbidity and, often, limit autonomy leading to premature entry into assisted living facilities. In Italy, in 2002 it was estimated that 28.6% of people over 65 years fall within a year: of these, 43% fall more than once and 60% of falls occur at home. Such falls can often result in fractures leading to the need for hospitalization with significant impact on both motor and cognitive function. Balance and gait rehabilitation are of primary importance for the recovery of a person's autonomy and independence, especially in older individuals who have undergone osteosynthesis or prosthesis surgery of the lower limbs. Technological and robotic rehabilitation allows for greater intensity, objectivity, and standardization in treatment protocols, as well as in outcome measurement. In this context, patient motivation is fuelled and maintained by both the sensory stimuli that support technological treatment and the challenge of achieving ever better results, objective feedback from instrumental assessments. Osteoarthritic patients who have undergone osteosynthesis or lower extremity prosthetic surgery require special attention, especially with the goal of preventing further accidents and reducing the patient's risk of falling. Given these considerations, it is believed that conventional physical therapy combined with technological balance treatment may be more effective on rehabilitation outcome than conventional therapy alone.
Detailed Description
Twenty-four patients of both sexes will be recruited, evaluated, and treated at Rehabilitation and Physical Medicine Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS of Rome, from August 2022 to August 2023. Patients will be divided into two groups by 1:1 randomization ratio: one group (Technological Group, TG) will perform specific rehabilitation for the balance using the robotic platform (Hunova®, Movendo Technology srl, Genova, IT) 3 times a week, for 4 weeks (12 total sessions), for 45 minutes of treatment, in addition to the conventional treatment and one group will perform only the conventional treatment (Control Group, CG), as per daily routine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Osteoarthritis, Hip, Gait Disorders in Old Age, Balance; Distorted
Keywords
Rehabilitation, Technology, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional pilot randomized controlled trial
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Technological Group
Arm Type
Experimental
Arm Description
Technological group (TG) patients will undergo robotic treatment for the improvement balance through the robotic platform (Hunova® Movendo Technology srl, Genova, IT), 3 times per week for 45 minutes each, in addition to the conventional treatment (total 180 minutes per day). In particular, the technological rehabilitation performed employing a footboard will be mostly aimed at improving the balance both in sitting and standing position, and will be proposed static and dynamic exercises, exercises dual-task exercises, and exercises to improve trunk control.
Arm Title
No Intervention: Control Group
Arm Type
No Intervention
Arm Description
Congrol Group (CG) patients will undergo conventional rehabilitation treatment only, using the main rehabilitation methods (e.g., neurocognitive theory, Bobath Concept, Progressive neuromuscular facilitation, etc.).
Intervention Type
Device
Intervention Name(s)
Technological Rehabilitation
Other Intervention Name(s)
Hunova® Movendo Technology srl
Intervention Description
Specific rehabilitation for balance disorder using the robotic platform
Primary Outcome Measure Information:
Title
Berg Balance Scale (BBS)
Description
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Time Frame
Change from Baseline Ambulation Index at 4 weeks
Secondary Outcome Measure Information:
Title
Motricity Index (MI)
Description
The Motricity Index can be used to assess the motor impairment in a patient who has had a stroke. Test for each leg: (1) ankle dorsiflexion with foot in a plantar flexed position 14 points are given if there is less than a full range of dorsiflexion (2) knee extension with the foot unsupported and the knee at 90° 14 points are given for less than 50% of full extension 19 points are given for full extension yet it can be easily pushed down (3) hip flexion with the hip bent at 90° moving the knee towards the chin 14 points are given if there is less than a full range of passive motion 19 points are given if the hip is fully flexed yet it can be easily pushed down. Interpretation: minimum score: 0 maximum score: 100
Time Frame
Change from Baseline Ambulation Index at 4 weeks
Title
Timed Up and Go Test (TUG)
Description
The Timed Up and Go test (TUG) measures in seconds the time it takes a subject to rise from a chair, walk a distance of 3 meters, turn, walk back to the chair and sit down. The performance is rated on a scale of 1 to 5 (where 1 is normal and 5 is severely abnormal) according to the observer's perception of the patient's risk of falling. The timed part of the test records the mean time (in seconds) from initial getting up to re-seating. Patients are compared with the mean time of adults in their age group, 60 to 69, 70 to 79, and 80 to 99 years of age.
Time Frame
Change from Baseline Ambulation Index at 4 weeks
Title
Knee Injury and Osteoarthritis Outcome Score - Italian Version (KOOS-I)
Description
KOOS-I is a self-administered questionnaire of 42 items and 5 sub-scales investigating different aspects: Symptoms (7 items, 2 inherent to stiffness); Pain (9 items); Functions and activities of daily living (17 items); Sports and recreation (5 items); and Quality of life in relation to the knee (4 items). All Scale Items present the same response mode by making use of a 5-point Likert scale ranging from 0 (no problems or difficulties) to 4 (high problems or difficulties).
Time Frame
Change from Baseline Ambulation Index at 4 weeks
Title
Hip disability and Osteoarthritis Outcome Score - Italian version (HOOS-I)
Description
HOOS-I is a self-administered questionnaire designed to assess reported symptoms at the hip joint level in subjects with or without primary osteoarthritis and following hip arthroplasty surgery. HOOS-I consists of 40 items divided into 5 subscales that assess five distinct dimensions relevant to the patient: Symptoms (3 items on symptoms and 2 on stiffness); Pain (10 items); Activities of Daily Living (ADL) (17 items); Physical function, sports and leisure activities (4 items); Quality of life (4 items). The patient has to express his/her opinion through standardized response options based on the 5-point Likert scale (none, mild, moderate, severe, extreme); each response is assigned a score ranging from 0 (no problem) to 4 (extreme problems).
Time Frame
Change from Baseline Ambulation Index at 4 weeks
Title
Ambulation Index (AI)
Description
The Ambulation Index is a rating scale to assess mobility by evaluating the time and degree of assistance required to walk 8 meters. Scores range from 0 (asymptomatic and fully active) to 10 (bedridden). The patient is asked to walk a marked 8 meters course as quickly and safely as possible. The examiner records the time and type of assistance (e.g., cane, walker, crutches) needed. Although the patient's walking is timed, the time is not used directly but is utilized in conjunction with other factors to rate the patient on an ordinal scale with 11 gradations. 0 = Asymptomatic; fully active. 10 = Bedridden
Time Frame
Change from Baseline Ambulation Index at 4 weeks
Title
Walking handicap scale (WHS)
Description
The Walking handicap scale (WHS) is an assessment tool that allows us to evaluate the quality of walking in the home and social environment through a a scale comprising six categories. 1 = Physiological walking: walking only as exercise 6 = Unrestricted walking in social settings: independent in all activities, on uneven ground, in crowded places, shows complete independence in public places
Time Frame
Change from Baseline Walking handicap scale at 4 weeks
Title
Functional Ambulation Classification (FAC)
Description
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. To use the FAC, an assessor asks the subject various questions and briefly observes their walking ability to provide a rating from 0 to 5. A score of 0 indicates that the patient is a non-functional ambulator (cannot walk); A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3). A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score).
Time Frame
Change from Baseline Functional Ambulation Classification at 4 weeks
Title
10 Meter Walk Test (10mWT)
Description
The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance. The total time taken to ambulate 6 meters (m) is recorded to the nearest hundredth of a second. 6 m is then divided by the total time (in seconds) taken to ambulate and recorded in m/s. The time is measured for the middle 6 m to allow for patient acceleration and deceleration. The time is started when any part of the leading foot crosses the plane of the 2-m mark. The time is stopped when any part of the leading foot crosses the plane of the 8-m mark.1 The time to walk the middle 6m, the level of assistance, and type of assistive device and/or bracing used will be documented. If a patient requires total assistance or is unable to ambulate at all, a score of 0 m/s will be documented.
Time Frame
Change from Baseline 10 Meter Walk Test at 4 weeks
Title
Six-Minute Walk test (6MWT)
Description
The six-minute walk test (6MWT) is a sub-maximal exercise test used to assess walking endurance and aerobic capacity. Participants will walk around the perimeter of a set circuit for a total of six minutes. The score of the test is the distance a patient walks in 6 minutes (measured in meters and can round to the nearest decimal point). Distance (in meters) covered in six minutes is calculated by multiplying the number of total laps by 12 meters and adding the distance of the partial lap completed at the time the test ended.
Time Frame
Change from Baseline 10 Meter Walk Test at 4 weeks
Title
Modified Barthel Index (mBI)
Description
The modified Barthel Index (mBI) for activities of daily living is meant to be used in the assessment of patient performance (or degree of assistance required) with respect to self-care, sphincter management, transfers and locomotion. The index consist of 10 items (each scored with a number of points) that relate to activities of daily living (ADLs) where the final score is calculated by summing the points awarded to each item. A five-point rating scales for each item to improve sensitivity to detecting change. The 10 items assessed relate to help needed with feeding, bathing, grooming, dressing, transfers, walking, climbing stairs, presence or absence of fecal incontinence and urinary incontinence. The score ranges from 0 (maximum dependence) to 100 (maximum independence)
Time Frame
Change from Baseline 10 Meter Walk Test at 4 weeks
Title
EuroQol- 5 Dimension (EQ-5D)
Description
EQ-5D is an instrument which evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ- 5D index an utility scores anchored at 0 for death and 1 for perfect health.
Time Frame
Change from Baseline 10 Meter Walk Test at 4 weeks
Title
Modified Fatigue Impact Scale (MFIS)
Description
The Modified Fatigue Impact Scale (MFIS) is an instrument that provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items while the abbreviated version has 5 items. The MFIS is a structured, self-report questionnaire that the patient can generally complete with little or no intervention from an interviewer. However, patients with visual or upper extremity impairments may need to have the MFIS administered as an interview. Interviewers should be trained in basic interviewing skills and in the use of this instrument. The total score for the MFIS is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items.
Time Frame
Change from Baseline 10 Meter Walk Test at 4 weeks
Title
Fatigue Scale for Motor and Cognitive Function (FSMC)
Description
The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue). Two subscales (mental and physical fatigue) can be made. Items included in the subscale mental are 1-4-7-8-11-13-15-17-18-20 and items included in the subscale physical are 2-3-5-6-9-10-12-14-16-19.
Time Frame
Change from Baseline 10 Meter Walk Test at 4 weeks
Title
Frontal Assessment Battery (FAB)
Description
The FAB is a brief tool that can be used at the bedside or in a clinic setting to assist in discriminating between dementias with a frontal dysexecutive phenotype and Dementia of Alzheimer"s Type (DAT). The FAB has validity in distinguishing Fronto-temporal type dementia from DAT in mildly demented patients (MMSE > 24). Total score is from a maximum of 18, higher scores indicating better performance.
Time Frame
Change from Baseline 10 Meter Walk Test at 4 weeks
Title
Trial Making Test (TMT)
Description
The Trail Making Test (TMT) measures flexibility of thinking on a visual-motor sequencing task. It consists of two parts, A and B, where 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Trail A: Average 29 seconds, Deficient > 78 seconds, Rule of Thumb Most in 90 seconds Trail B: Average 75 seconds, Deficient > 273 seconds, Rule of Thumb Most in 3 minutes
Time Frame
Change from Baseline 10 Meter Walk Test at 4 weeks
Title
Stroop Colour Word Test (SCWT)
Description
The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. The subject is asked to read the words in the first task, to name colors in the second and third tasks. It is necessary to mark both any mistakes made but also the time spent on each task. The cut-off for the error interference effect is 4.24, while the cut-off for the time interference effect is 36.92.
Time Frame
Change from Baseline 10 Meter Walk Test at 4 weeks
Title
Cancellation Test of Digit (CTD)
Description
In the Cancellation Test of Digits (CTD) the patient is asked to cross out with a pencil, as quickly as possible, all numbers corresponding to those indicated at the top of each matrix. Line A serves as an example. The performance of the subject is counted from line I. Corrections of the barriers are not allowed. The task of the examiner is mark the point at which the subject has exceeded the maximum time of the test, but let the subject let the subject finish his task for each matrix. The maximum time for each matrix is 45 sec- and is considered from the moment the subject finishes the run in. If the subject takes less time than the maximum time, it will be indicated at the end of each matrix. The time cut-off for the test is 23.9.
Time Frame
Change from Baseline 10 Meter Walk Test at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 55 years; Patients with outcomes of surgery for prosthetic hip or knee replacement; Latency from the acute event between 15 days and 3 months; Cognitive abilities to execute simple orders and understand the physical therapist's directions [assessed by Token Test (score ≥26.5)]; Ability to walk independently or with little assistance; Ability to understand and sign informed consent. Exclusion Criteria: Presence of systemic, neurological, cardiac pathologies that make walking hazardous or cause motor deficits; Presence of oncological pathologies; Presence of plantar ulcers; Partial or total amputation of foot segments.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Giovannini, MD, phD
Phone
+390630154382
Email
silvia.giovannini@policlinicogemelli.it
First Name & Middle Initial & Last Name or Official Title & Degree
Letizia castelli, MS
Phone
+390630154382
Email
letizia.castelli@policlinicogemelli.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Giovannini, MD, phD
Organizational Affiliation
Fondazione Policlinico Universitaria A. Gemelli IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Giovannini, MD, phD
Phone
+390630154382
Email
silvia.giovannini@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Letizia Castelli, MS
Phone
+390630154382
Email
letizia.castelli@policlinicogemelli.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
R Core Team (2021). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/.
Results Reference
background
PubMed Identifier
28303110
Citation
Alessandri G, Zuffiano A, Perinelli E. Evaluating Intervention Programs with a Pretest-Posttest Design: A Structural Equation Modeling Approach. Front Psychol. 2017 Mar 2;8:223. doi: 10.3389/fpsyg.2017.00223. eCollection 2017.
Results Reference
result
PubMed Identifier
28946585
Citation
Aprile I, Iacovelli C, Padua L, Galafate D, Criscuolo S, Gabbani D, Cruciani A, Germanotta M, Di Sipio E, De Pisi F, Franceschini M. Efficacy of Robotic-Assisted Gait Training in chronic stroke patients: Preliminary results of an Italian bi-centre study. NeuroRehabilitation. 2017;41(4):775-782. doi: 10.3233/NRE-172156.
Results Reference
result
Citation
Burnham KP, Anderson DR. Multimodel Inference: Understanding AIC and BIC in Model Selection. Sociological Methods & Research. 2004;33(2):261-304. doi:10.1177/0049124104268644
Results Reference
result
PubMed Identifier
26728268
Citation
Castelli L, De Luca F, Marchetti MR, Sellitto G, Fanelli F, Prosperini L. The dual task-cost of standing balance affects quality of life in mildly disabled MS people. Neurol Sci. 2016 May;37(5):673-9. doi: 10.1007/s10072-015-2456-y. Epub 2016 Jan 4.
Results Reference
result
PubMed Identifier
26234280
Citation
Cattaneo D, Carpinella I, Aprile I, Prosperini L, Montesano A, Jonsdottir J. Comparison of upright balance in stroke, Parkinson and multiple sclerosis. Acta Neurol Scand. 2016 May;133(5):346-54. doi: 10.1111/ane.12466. Epub 2015 Aug 3.
Results Reference
result
Citation
Davis RB, Õunpuu S, Tyburski D, Gage JR. A gait analysis data collection and reduction technique. Hum. Mov. Sci. 1991; 10, 575-587
Results Reference
result
PubMed Identifier
25748615
Citation
Glyn-Jones S, Palmer AJ, Agricola R, Price AJ, Vincent TL, Weinans H, Carr AJ. Osteoarthritis. Lancet. 2015 Jul 25;386(9991):376-87. doi: 10.1016/S0140-6736(14)60802-3. Epub 2015 Mar 4.
Results Reference
result
PubMed Identifier
31078660
Citation
Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
Results Reference
result
PubMed Identifier
18929686
Citation
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
Results Reference
result
Citation
Hu LT, Bentler PM. Fit indices in covariance structure modeling: Sensitivity to underparameterized model misspecification. Psychological Methods. 1998, 3(4), 424-453. doi: 10.1037/1082-989X.3.4.424
Results Reference
result
Citation
Hu LT, Bentler PM. Cutoff Criteria for Fit Indexes in Covariance Structure Analysis: Conventional Criteria versus New Alternatives. Structural Equation Modeling, 1999, 6, 1-55. doi: 10.1080/10705519909540118
Results Reference
result
Citation
Julious, SA. 'Sample size of 12 per group rule of thumb for a pilot study'. Pharmaceutical Statistics. 2005, Vol 4. Pages 287-291.
Results Reference
result
Citation
Kline, RB. (2016). Principles and Practice of Structural Equation Modeling, 4th Edn. New York, NY: The Guilford Press.
Results Reference
result
Citation
MacCallum RC, Browne MW, Sugawara HM. Power analysis and determination of sample size for covariance structure modeling. Psychological Methods, 1996, 1(2), 130-149. doi: 10.1037/1082-989X.1.2.130
Results Reference
result
Citation
Muthén, BO and Curran PJ. General longitudinal modeling of individual differences in experimental designs: a latent variable framework for analysis and power estimation. Psychol. Methods 1997, 2, 371-402. doi: 10.1037/1082-989X.2.4.371
Results Reference
result
PubMed Identifier
27521436
Citation
Prosperini L, Castelli L, De Luca F, Fabiano F, Ferrante I, De Giglio L. Task-dependent deterioration of balance underpinning cognitive-postural interference in MS. Neurology. 2016 Sep 13;87(11):1085-92. doi: 10.1212/WNL.0000000000003090. Epub 2016 Aug 12.
Results Reference
result
PubMed Identifier
25770078
Citation
Prosperini L, Castelli L, Sellitto G, De Luca F, De Giglio L, Gurreri F, Pozzilli C. Investigating the phenomenon of "cognitive-motor interference" in multiple sclerosis by means of dual-task posturography. Gait Posture. 2015 Mar;41(3):780-5. doi: 10.1016/j.gaitpost.2015.02.002. Epub 2015 Feb 21.
Results Reference
result
PubMed Identifier
22230308
Citation
Sinusas K. Osteoarthritis: diagnosis and treatment. Am Fam Physician. 2012 Jan 1;85(1):49-56. Erratum In: Am Fam Physician. 2012 Nov 15;86(10):893.
Results Reference
result

Learn more about this trial

Robotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients.

We'll reach out to this number within 24 hrs