Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Fatigue Severity Score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Fatigue Severity Score
Time Frame: 3 months after treatment
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)
Time Frame: 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)
Time Frame: 3 months after treatment
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)
Time Frame: 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)
Time Frame: 3 months after treatment
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 Outcomes
- Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health(after treatment (4th week))
- Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health(3 months after treatment)
- Expanded Disability Status Scale (EDSS)(3 months after treatment)
- Functional Ambulation Classification(3 months after treatment)
- Walking Ability(3 months after treatment)
- Berg Balance Test (BBT)(3 months after treatment)