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Comparison of the Effects of Robotic Rehabilitation Versus Traditional Balance Training on Balance and Fear of Falling in Stroke Patients

Primary Purpose

Stroke, Stroke Rehabilitation, Robotic Exoskeleton

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Combined RAGT and TBT
balance exercises
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Stroke Rehabilitation, Robot assisted gait training, Balance training, Fear of falling

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being 18 years or older
  • Volunteering to participate in the study
  • Having been diagnosed with stroke (at least 3 months)
  • Age range 18 ≥ or 75 <
  • Being able to walk independently (Functional Ambulation Scale> 3)
  • Modified Ashworth Scale ≤ 2 spasticity value

Exclusion Criteria:

  • Being under the age of 18
  • Having severe visual and cognitive impairment
  • Having severe cardiovascular disease
  • Having experienced musculoskeletal injuries (osteoarthritis, contracture, osteoporosis, etc. in the joints of the lower extremities) or any skin problem (such as pressure sores)
  • Being involved in a robotic rehabilitation program before

Sites / Locations

  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined RAGT and TBT

TBT Only

Arm Description

Participants will be treated with Lokomat for 40 minutes, twice a week for 5 weeks, and RAGT with a body weight support system and combined TBT for 40 minutes each session 3 times a week. During RAGT, 30-40% of each participant's body weight will be taken with the body weight support system. In patients without drop foot and knee instability in the sessions after the first session, the body weight will be reduced by 10% and progression will be achieved. The speed of the treadmill will be adjusted between 1.2-2.6 km/h and the maximum speed tolerated by the patient will be reached during the sessions. TBT exercises 3 times a week for 40 minutes (weight transfer to the paretic leg during sitting and standing, weight transfer during sitting and standing with or without an assistive device) will be personalized according to the patient. Progression of exercises will be provided by adding upper extremity and trunk activities in addition to exercises.

Participants were given balance exercises (weight transfer to the paretic leg during sitting and standing, weight transfer during sitting and standing without an assistive device, walking on a flat surface to the forward and sideways) for 5 weeks, 5 times a week and for 40 minutes in each session. lying down while sitting and standing) will be applied.

Outcomes

Primary Outcome Measures

Berg Balance Scale
It is used to evaluate postural control and to determine fall risk. It consists of 14 questions with parameters such as standing up from sitting, standing, transfers, taking a step, turning. A score of 0-4 is given for each question and the time the person performs the desired activity is recorded. At the end of the test, the total score received by the subject is calculated.
EncephaLog by Montfort® App
The phone, which is fixed to the sternum of the participant, evaluates the static and dynamic balance with the integration of accelerometer and gyroscope. Static balance is evaluated in a neutral stance with feet open, feet together, feet together and eyes closed, in tandem stance for 10 seconds for each test. Starts the dynamic balance assessment with a 5 second countdown followed by a short audible tone and vibration. Participants stand up without any assistance or arm support and walk at their natural speed towards a cone positioned on the ground 3 m from their chair, then turn around the cone and walk back and sit. It provides objective data by recording the walking time and the test is repeated twice.
International Fall Efficiency Scale (FES-I)
It was developed to assess the fear of falling. The cut-off point is 24 to distinguish between people who have a fear of falling and those who do not. The participant is asked to rate his/her concern about the possibility of falling while performing activities of daily living. Fear of falling is determined by adding the scores between 1-4 obtained from each question after completing 16 questions.
Timed Get Up and Go Test
It is a measure for assessing balance and functional mobility. A chair and a stopwatch are required to administer the test. The shoes that are always used during the test are used and the test is continued with the assistive device if used. The person is asked to get up from a chair, walk 3 meters, turn around, walk back and sit, and the score is calculated by measuring how many seconds he or she completes the test. Completing the test in more than 12 seconds indicates that the risk of falling is high.

Secondary Outcome Measures

Foot Posture Index
In this index, the medial and lateral palpation of the distal talus, the inequality in submalleolar and supramalleolar recesses, the position of the calcaneus, the medial protrusion of the navicular region in posterior observation, the evaluation of MLA, and the number of fingers visible medially or laterally when viewed from the posterior are evaluated. The regions examined are evaluated for each item up to (+2) according to the degree of pronation and (-2) according to the degree of supination, and the total score is determined as the sum of these values.
Functional Ambulation Scale
In this classification system, 6 functional levels are defined. This classification system is widely used to evaluate the outcome or effectiveness of rehabilitation and functional level in individuals recovering from stroke.
Modified Ashworth Scale
It is a 6-item scale that focuses on the subjective clinical assessment of muscle tone. It measures the level of resistance to passive movement, but cannot assess the speed of passive joint movement, the angle of contraction swing, or potential tendon retraction. MAS is effective in clinical practice due to its ease of use and speed.
Fugl-Meyer Test- Lower Extremity
The lower extremity section with a score of 34 including 17 items was used. Evaluates reflexes, synergy-dependent or synergy-independent voluntary movement, coordination and speed. Each item is evaluated out of 2 as follows; 0: cannot complete the movement/ no active movement, 1: partial movement, 2: the movement is completed / movements can be performed normally.

Full Information

First Posted
July 1, 2022
Last Updated
July 6, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05447754
Brief Title
Comparison of the Effects of Robotic Rehabilitation Versus Traditional Balance Training on Balance and Fear of Falling in Stroke Patients
Official Title
Comparison of the Effects of Robotic Rehabilitation Versus Traditional Balance Training on Balance and Fear of Falling in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
January 13, 2023 (Anticipated)
Study Completion Date
April 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

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
In the literature, it has been observed that traditional balance training (TBT) and robot-assisted walking training (RAGT) in stroke patients stimulate the balance mechanism by supporting the spinal muscles symmetrically and functionally. However, it is seen that there is no clear protocol for RAGT in the chronic period. Combined RAGT and TBT approaches over ten weeks have been shown to be more effective than TBT alone for the acute and subacute period. However, there is no definite expression for chronic period effects. No study was found in the literature in which an objective measuring device was used for balance assessment of patients receiving TBT and RAGT. If changes are detected between the two treatment groups in balance education in stroke patients as a result of objective evaluation, our study will lead to the necessity of including these changes in the treatment. Considering the effect of balance on activities of daily living, we believe that objective evaluation of the changes in balance after TBT and RAGT in stroke patients and shaping the treatment according to the evaluation results will contribute to the literature.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke Rehabilitation, Robotic Exoskeleton
Keywords
Stroke, Stroke Rehabilitation, Robot assisted gait training, Balance training, Fear of falling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined RAGT and TBT
Arm Type
Experimental
Arm Description
Participants will be treated with Lokomat for 40 minutes, twice a week for 5 weeks, and RAGT with a body weight support system and combined TBT for 40 minutes each session 3 times a week. During RAGT, 30-40% of each participant's body weight will be taken with the body weight support system. In patients without drop foot and knee instability in the sessions after the first session, the body weight will be reduced by 10% and progression will be achieved. The speed of the treadmill will be adjusted between 1.2-2.6 km/h and the maximum speed tolerated by the patient will be reached during the sessions. TBT exercises 3 times a week for 40 minutes (weight transfer to the paretic leg during sitting and standing, weight transfer during sitting and standing with or without an assistive device) will be personalized according to the patient. Progression of exercises will be provided by adding upper extremity and trunk activities in addition to exercises.
Arm Title
TBT Only
Arm Type
Active Comparator
Arm Description
Participants were given balance exercises (weight transfer to the paretic leg during sitting and standing, weight transfer during sitting and standing without an assistive device, walking on a flat surface to the forward and sideways) for 5 weeks, 5 times a week and for 40 minutes in each session. lying down while sitting and standing) will be applied.
Intervention Type
Other
Intervention Name(s)
Combined RAGT and TBT
Intervention Description
Combined RAGT and TBT: Participants will be treated with Lokomat for 40 minutes, twice a week for 5 weeks, and RAGT with a body weight support system and combined TBT for 40 minutes each session 3 times a week. During RAGT, 30-40% of each participant's body weight will be taken with the body weight support system. In patients without drop foot and knee instability in the sessions after the first session, the body weight will be reduced by 10% and progression will be achieved. The speed of the treadmill will be adjusted between 1.2-2.6 km/h and the maximum speed tolerated by the patient will be reached during the sessions. TBT exercises 3 times a week for 40 minutes (weight transfer to the paretic leg during sitting and standing, weight transfer during sitting and standing with or without an assistive device) will be personalized according to the patient. Progression of exercises will be provided by adding upper extremity and trunk activities in addition to exercises.
Intervention Type
Other
Intervention Name(s)
balance exercises
Intervention Description
TBT
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
It is used to evaluate postural control and to determine fall risk. It consists of 14 questions with parameters such as standing up from sitting, standing, transfers, taking a step, turning. A score of 0-4 is given for each question and the time the person performs the desired activity is recorded. At the end of the test, the total score received by the subject is calculated.
Time Frame
5 weeks
Title
EncephaLog by Montfort® App
Description
The phone, which is fixed to the sternum of the participant, evaluates the static and dynamic balance with the integration of accelerometer and gyroscope. Static balance is evaluated in a neutral stance with feet open, feet together, feet together and eyes closed, in tandem stance for 10 seconds for each test. Starts the dynamic balance assessment with a 5 second countdown followed by a short audible tone and vibration. Participants stand up without any assistance or arm support and walk at their natural speed towards a cone positioned on the ground 3 m from their chair, then turn around the cone and walk back and sit. It provides objective data by recording the walking time and the test is repeated twice.
Time Frame
5 weeks
Title
International Fall Efficiency Scale (FES-I)
Description
It was developed to assess the fear of falling. The cut-off point is 24 to distinguish between people who have a fear of falling and those who do not. The participant is asked to rate his/her concern about the possibility of falling while performing activities of daily living. Fear of falling is determined by adding the scores between 1-4 obtained from each question after completing 16 questions.
Time Frame
5 weeks
Title
Timed Get Up and Go Test
Description
It is a measure for assessing balance and functional mobility. A chair and a stopwatch are required to administer the test. The shoes that are always used during the test are used and the test is continued with the assistive device if used. The person is asked to get up from a chair, walk 3 meters, turn around, walk back and sit, and the score is calculated by measuring how many seconds he or she completes the test. Completing the test in more than 12 seconds indicates that the risk of falling is high.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Foot Posture Index
Description
In this index, the medial and lateral palpation of the distal talus, the inequality in submalleolar and supramalleolar recesses, the position of the calcaneus, the medial protrusion of the navicular region in posterior observation, the evaluation of MLA, and the number of fingers visible medially or laterally when viewed from the posterior are evaluated. The regions examined are evaluated for each item up to (+2) according to the degree of pronation and (-2) according to the degree of supination, and the total score is determined as the sum of these values.
Time Frame
5 weeks
Title
Functional Ambulation Scale
Description
In this classification system, 6 functional levels are defined. This classification system is widely used to evaluate the outcome or effectiveness of rehabilitation and functional level in individuals recovering from stroke.
Time Frame
5 weeks
Title
Modified Ashworth Scale
Description
It is a 6-item scale that focuses on the subjective clinical assessment of muscle tone. It measures the level of resistance to passive movement, but cannot assess the speed of passive joint movement, the angle of contraction swing, or potential tendon retraction. MAS is effective in clinical practice due to its ease of use and speed.
Time Frame
5 weeks
Title
Fugl-Meyer Test- Lower Extremity
Description
The lower extremity section with a score of 34 including 17 items was used. Evaluates reflexes, synergy-dependent or synergy-independent voluntary movement, coordination and speed. Each item is evaluated out of 2 as follows; 0: cannot complete the movement/ no active movement, 1: partial movement, 2: the movement is completed / movements can be performed normally.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being 18 years or older Volunteering to participate in the study Having been diagnosed with stroke (at least 3 months) Age range 18 ≥ or 75 < Being able to walk independently (Functional Ambulation Scale> 3) Modified Ashworth Scale ≤ 2 spasticity value Exclusion Criteria: Being under the age of 18 Having severe visual and cognitive impairment Having severe cardiovascular disease Having experienced musculoskeletal injuries (osteoarthritis, contracture, osteoporosis, etc. in the joints of the lower extremities) or any skin problem (such as pressure sores) Being involved in a robotic rehabilitation program before
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rüstem Mustafaoğlu, PhD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Effects of Robotic Rehabilitation Versus Traditional Balance Training on Balance and Fear of Falling in Stroke Patients

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