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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: robot assisted gait therapy
* Other: Conventional rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: robot assisted training (RAT)<br>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 | Other: robot assisted gait therapy<br>* 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.<br>|
| Active Comparator: conventional training (CT)<br>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker. | Other: Conventional rehabilitation<br>* Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline | 
| 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. | after treatment (4th week) | 
| 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. | 3 months after treatment | 
| 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. | Baseline | 
| 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. | After treatment (4th week) | 
| 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. | 3 months after treatment | 
| 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. | baseline | 
| 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. | After treatment (4th week) | 
| 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. | 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | after treatment (4th week) | 
| 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. | 3 months after treatment | 
| 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. | baseline | 
| 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. | after treatment (4th week) | 
| 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. | 3 months after treatment | 
| Functional Ambulation Classification | scored 0 to 5 (non functional ambulator to independant ambulator) | baseline | 
| Functional Ambulation Classification | scored 0 to 5 (non functional ambulator to independant ambulator) | after treatment (4th week) | 
| Functional Ambulation Classification | scored 0 to 5 (non functional ambulator to independant ambulator) | 3 months after treatment | 
| 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. | baseline | 
| 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. | after treatment (4th week) | 
| 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. | 3 months after treatment | 
| 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. | Baseline | 
| 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. | After treatment (4th week) | 
| 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. | 3 months after treatment | 
| 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. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, robot assisted gait training