Multiple Sclerosis
Conditions
Keywords
rehabilitation, robot assisted gait training
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.
Interventions
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.
OTHERConventional rehabilitation
Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists.
Sponsors
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity Score | baseline | 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) | Baseline | 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) | After treatment (4th week) | 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) | baseline | 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) | After treatment (4th week) | 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
| Measure | Time frame | Description |
|---|---|---|
| Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health | baseline | 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. |
| Berg Balance Test (BBT) | Baseline | 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. |
| Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health | 3 months after treatment | 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) | baseline | 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 | baseline | scored 0 to 5 (non functional ambulator to independant ambulator) |
| Walking Ability | baseline | The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Robot Assisted Training (RAT) 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 | 18 |
| Conventional Training (CT) Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker. | 19 |
| Total | 37 |
Baseline characteristics
| Characteristic | Robot Assisted Training (RAT) | Conventional Training (CT) | Total |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 9.2 | 44.7 years STANDARD_DEVIATION 8.4 | 44.8 years STANDARD_DEVIATION 8.7 |
| Disease duration | 14.1 years STANDARD_DEVIATION 5.9 | 13.4 years STANDARD_DEVIATION 6.2 | 13.7 years STANDARD_DEVIATION 6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 24 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Fatigue Severity Score | 4.4 score on a scale |
| Conventional Training (CT) | Fatigue Severity Score | 5.8 score on a scale |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Fatigue Severity Score | 5.5 score on a scale |
| Conventional Training (CT) | Fatigue Severity Score | 5.7 score on a scale |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Fatigue Severity Score | 5.5 score on a scale |
| Conventional Training (CT) | Fatigue Severity Score | 6 score on a scale |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A) | 7.5 score on a scale |
| Conventional Training (CT) | Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A) | 8 score on a scale |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A) | 5 score on a scale |
| Conventional Training (CT) | Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A) | 8 score on a scale |
Primary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A) | 5 score on a scale |
| Conventional Training (CT) | Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A) | 8 score on a scale |
Primary
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: After treatment (4th week)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Hospital Anxiety Depression Scale- Depression Subscale (HADS-D) | 5.5 score on a scale |
| Conventional Training (CT) | Hospital Anxiety Depression Scale- Depression Subscale (HADS-D) | 9 score on a scale |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Hospital Anxiety Depression Scale- Depression Subscale (HADS-D) | 6.5 score on a scale |
| Conventional Training (CT) | Hospital Anxiety Depression Scale- Depression Subscale (HADS-D) | 9 score on a scale |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Hospital Anxiety Depression Scale-Depression Subscale (HADS-D) | 8.5 score on a scale |
| Conventional Training (CT) | Hospital Anxiety Depression Scale-Depression Subscale (HADS-D) | 10 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Berg Balance Test (BBT) | 23 score on a scale |
| Conventional Training (CT) | Berg Balance Test (BBT) | 18 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Berg Balance Test (BBT) | 20 score on a scale |
| Conventional Training (CT) | Berg Balance Test (BBT) | 15 score on a scale |
Secondary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Berg Balance Test (BBT) | 24.5 score on a scale |
| Conventional Training (CT) | Berg Balance Test (BBT) | 18 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Expanded Disability Status Scale (EDSS) | 6.5 units on a scale |
| Conventional Training (CT) | Expanded Disability Status Scale (EDSS) | 6 units on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Expanded Disability Status Scale (EDSS) | 6 units on a scale |
| Conventional Training (CT) | Expanded Disability Status Scale (EDSS) | 6 units on a scale |
Secondary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Expanded Disability Status Scale (EDSS) | 6 units on a scale |
| Conventional Training (CT) | Expanded Disability Status Scale (EDSS) | 6 units on a scale |
Secondary
Functional Ambulation Classification
scored 0 to 5 (non functional ambulator to independant ambulator)
Time frame: after treatment (4th week)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Functional Ambulation Classification | 1 score on a scale |
| Conventional Training (CT) | Functional Ambulation Classification | 1 score on a scale |
Secondary
Functional Ambulation Classification
scored 0 to 5 (non functional ambulator to independant ambulator)
Time frame: 3 months after treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Functional Ambulation Classification | 1 score on a scale |
| Conventional Training (CT) | Functional Ambulation Classification | 1 score on a scale |
Secondary
Functional Ambulation Classification
scored 0 to 5 (non functional ambulator to independant ambulator)
Time frame: baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Functional Ambulation Classification | 1 score on a scale |
| Conventional Training (CT) | Functional Ambulation Classification | 1 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health | 32.9 score on a scale |
| Conventional Training (CT) | Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health | 29.1 score on a scale |
Secondary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health | 34.2 score on a scale |
| Conventional Training (CT) | Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health | 33.7 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health | 28.5 score on a scale |
| Conventional Training (CT) | Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health | 29.9 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Walking Ability | 50 meters |
| Conventional Training (CT) | Walking Ability | 60 meters |
Secondary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Walking Ability | 70 meters |
| Conventional Training (CT) | Walking Ability | 70 meters |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Robot Assisted Training (RAT) | Walking Ability | 60 meters |
| Conventional Training (CT) | Walking Ability | 65 meters |