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Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
robot assisted gait therapy
Conventional rehabilitation
Sponsored by
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring rehabilitation, robot assisted gait training

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-70 years old Multiple Sclerosis patients
  • EDSS score: 5.5-7.5
  • Being oriented and cooperated
  • Mini-mental score ≥24/30

Exclusion Criteria:

  • Modified Ashworth >3 in lower extremity muscles
  • Cognitive impairment
  • Botox injection within last 6-months
  • Having another neurological disease
  • Pregnancy or breast-feeding

Sites / Locations

  • Sultan Abdulhamid Han Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

robot assisted training (RAT)

conventional training (CT)

Arm Description

RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities

Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.

Outcomes

Primary Outcome Measures

Fatigue Severity Score
Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
Fatigue Severity Score
Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
Fatigue Severity Score
Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
Hospital Anxiety Depression Scale-Depression Subscale (HADS-D)
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A)
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.
Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.
Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.

Secondary Outcome Measures

Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health
The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. Each composite summary scored 0-100. Higher values indicate better QoL.
Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health
The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. Each composite summary scored 0-100. Higher values indicate better QoL.
Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health
The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. Each composite summary scored 0-100. Higher values indicate better QoL.
Expanded Disability Status Scale (EDSS)
The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Expanded Disability Status Scale (EDSS)
The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Expanded Disability Status Scale (EDSS)
The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Functional Ambulation Classification
scored 0 to 5 (non functional ambulator to independant ambulator)
Functional Ambulation Classification
scored 0 to 5 (non functional ambulator to independant ambulator)
Functional Ambulation Classification
scored 0 to 5 (non functional ambulator to independant ambulator)
Walking Ability
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Walking Ability
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Walking Ability
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Berg Balance Test (BBT)
Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.
Berg Balance Test (BBT)
Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.
Berg Balance Test (BBT)
Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.

Full Information

First Posted
January 9, 2019
Last Updated
April 11, 2021
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT03801473
Brief Title
Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients
Official Title
Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 4, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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
The aim of this study is to compare conventional neurorehabilitation with robot-assisted gait training program in terms of fatigue, anxiety, depression and quality of life.
Detailed Description
Gait disturbances are common in Multiple Sclerosis (MS) patients. Nowadays, gait training with robot assisted technology is used for rehabilitation. In several studies conventional rehabilitation was compared with robot assisted rehabilitation program, and they found no superior effects of robot assisted walking program. In this study we aimed to compare these modalities in terms of fatigue, anxiety and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
rehabilitation, robot assisted gait training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Initial assessments will be performed by first clinician (EA). Then, patients will be randomly grouped. The outcome assessor, second clinician (TOU) will be blinded.
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
robot assisted training (RAT)
Arm Type
Experimental
Arm Description
RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities
Arm Title
conventional training (CT)
Arm Type
Active Comparator
Arm Description
Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Intervention Type
Other
Intervention Name(s)
robot assisted gait therapy
Intervention Description
The Robogait is a fixed lower body hip-knee exoskeleton. The user's weight is supported by a combination of an overhead attached harness and the support from the exoskeleton.
Intervention Type
Other
Intervention Name(s)
Conventional rehabilitation
Intervention Description
Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists.
Primary Outcome Measure Information:
Title
Fatigue Severity Score
Description
Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
Time Frame
baseline
Title
Fatigue Severity Score
Description
Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
Time Frame
after treatment (4th week)
Title
Fatigue Severity Score
Description
Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
Time Frame
3 months after treatment
Title
Hospital Anxiety Depression Scale-Depression Subscale (HADS-D)
Description
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
Time Frame
Baseline
Title
Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)
Description
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
Time Frame
After treatment (4th week)
Title
Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)
Description
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
Time Frame
3 months after treatment
Title
Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A)
Description
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.
Time Frame
baseline
Title
Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
Description
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.
Time Frame
After treatment (4th week)
Title
Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
Description
Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D). HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health
Description
The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. Each composite summary scored 0-100. Higher values indicate better QoL.
Time Frame
baseline
Title
Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health
Description
The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. Each composite summary scored 0-100. Higher values indicate better QoL.
Time Frame
after treatment (4th week)
Title
Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health
Description
The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. Each composite summary scored 0-100. Higher values indicate better QoL.
Time Frame
3 months after treatment
Title
Expanded Disability Status Scale (EDSS)
Description
The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Time Frame
baseline
Title
Expanded Disability Status Scale (EDSS)
Description
The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Time Frame
after treatment (4th week)
Title
Expanded Disability Status Scale (EDSS)
Description
The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Time Frame
3 months after treatment
Title
Functional Ambulation Classification
Description
scored 0 to 5 (non functional ambulator to independant ambulator)
Time Frame
baseline
Title
Functional Ambulation Classification
Description
scored 0 to 5 (non functional ambulator to independant ambulator)
Time Frame
after treatment (4th week)
Title
Functional Ambulation Classification
Description
scored 0 to 5 (non functional ambulator to independant ambulator)
Time Frame
3 months after treatment
Title
Walking Ability
Description
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Time Frame
baseline
Title
Walking Ability
Description
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Time Frame
after treatment (4th week)
Title
Walking Ability
Description
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Time Frame
3 months after treatment
Title
Berg Balance Test (BBT)
Description
Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.
Time Frame
Baseline
Title
Berg Balance Test (BBT)
Description
Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.
Time Frame
After treatment (4th week)
Title
Berg Balance Test (BBT)
Description
Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.
Time Frame
3 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-70 years old Multiple Sclerosis patients EDSS score: 5.5-7.5 Being oriented and cooperated Mini-mental score ≥24/30 Exclusion Criteria: Modified Ashworth >3 in lower extremity muscles Cognitive impairment Botox injection within last 6-months Having another neurological disease Pregnancy or breast-feeding
Facility Information:
Facility Name
Sultan Abdulhamid Han Training and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27762641
Citation
Lefeber N, Swinnen E, Kerckhofs E. The immediate effects of robot-assistance on energy consumption and cardiorespiratory load during walking compared to walking without robot-assistance: a systematic review. Disabil Rehabil Assist Technol. 2017 Oct;12(7):657-671. doi: 10.1080/17483107.2016.1235620. Epub 2016 Oct 20.
Results Reference
background
PubMed Identifier
28241776
Citation
Straudi S, Manfredini F, Lamberti N, Zamboni P, Bernardi F, Marchetti G, Pinton P, Bonora M, Secchiero P, Tisato V, Volpato S, Basaglia N. The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial. Trials. 2017 Feb 27;18(1):88. doi: 10.1186/s13063-017-1838-2.
Results Reference
background
PubMed Identifier
24904361
Citation
Gandolfi M, Geroin C, Picelli A, Munari D, Waldner A, Tamburin S, Marchioretto F, Smania N. Robot-assisted vs. sensory integration training in treating gait and balance dysfunctions in patients with multiple sclerosis: a randomized controlled trial. Front Hum Neurosci. 2014 May 22;8:318. doi: 10.3389/fnhum.2014.00318. eCollection 2014.
Results Reference
background
PubMed Identifier
34686632
Citation
Ozsoy-Unubol T, Ata E, Cavlak M, Demir S, Candan Z, Yilmaz F. Effects of Robot-Assisted Gait Training in Patients With Multiple Sclerosis: A Single-Blinded Randomized Controlled Study. Am J Phys Med Rehabil. 2022 Aug 1;101(8):768-774. doi: 10.1097/PHM.0000000000001913. Epub 2021 Oct 21.
Results Reference
derived

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Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients

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