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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
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.
Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists.
Sultan Abdulhamid Han Training and Research Hospital
Istanbul, Turkey (Türkiye)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months after treatment
Functional Ambulation Classification
scored 0 to 5 (non functional ambulator to independant ambulator)
Time frame: baseline
Functional Ambulation Classification
scored 0 to 5 (non functional ambulator to independant ambulator)
Time frame: after treatment (4th week)
Functional Ambulation Classification
scored 0 to 5 (non functional ambulator to independant ambulator)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months after treatment