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The Hybrid Assistive Limb (HAL) exoskeleton detects bioelectrical signals from the muscles, responds to the intention of voluntary movement, and provides biological feedback. In this study, the effects of HAL application on walking performance and balance in patients with multiple sclerosis will be examined in a single-center, controlled design. Participants will undergo walking rehabilitation with HAL for 1 hour per day, 5 days a week, for a total of 2 months. Walking and balance performance will be assessed before and after the intervention using the 10-Minute Walk Test (10MWT) to measure maximum walking speed, the 6-Minute Walk Test (6MWT) to evaluate walking endurance and cardiorespiratory performance, and the Timed Up and Go Test (TUG) to assess functional mobility and dynamic balance. Additionally, walking parameters and static balance will be measured using Tecnobody systems. Appropriate statistical tests will be applied, and a significance level of p<0.05 will be considered.
The Hybrid Assistive Limb (HAL) exoskeleton is a robotic device that detects bioelectrical signals from the muscles, responds to the user's intention to move voluntarily, and provides biological feedback to support motor function. This study aims to investigate the effects of HAL-assisted walking rehabilitation on walking performance and balance in patients with MS in a single-center, controlled design.
Participants will undergo HAL-assisted walking rehabilitation for 1 hour per day, 5 days a week, over a period of 2 months. Assessments will be conducted before and after the intervention by trained clinicians and physiotherapists under standardized conditions. Walking and balance performance will be evaluated using the 10-Minute Walk Test (10MWT) to measure maximum walking speed, the 6-Minute Walk Test (6MWT) to assess walking endurance and cardiorespiratory performance, and the Timed Up and Go Test (TUG) to evaluate functional mobility and dynamic balance. Additionally, walking parameters-including step length, cadence, walking speed, joint range of motion of the hip, knee, and trunk, and gait symmetry-will be analyzed using the Tecnobody Walker View system, while static balance will be measured with the Tecnobody D-Wall system under eyes-open and eyes-closed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MS | Experimental | Participants will receive walking rehabilitation with a lower extremity type Hybrid Assistive Limb (HAL) device, 5 days a week, 1 hour per day, for a total of 2 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Assistive Limb (HAL) | Device | Participants will receive walking rehabilitation with a lower extremity type Hybrid Assistive Limb (HAL) device, 5 days a week, 1 hour per day, for a total of 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 10-Meter Walk Test (10mWT) | 10-Meter Walk Test (10mWT): In this study, the 10-Meter Walk Test (10mWT) will be administered to assess walking speed. Participants will be asked to walk at a comfortable pace along the middle 10-meter section of a 14-meter walkway on level ground. | Baseline (study start) and at 2 months. |
| Timed Up and Go Test (TUG) | During the test, participants will be asked to rise from a 47 cm high chair with a backrest and armrests, walk a distance of 3 meters, return to the starting point by turning at a marked cone, and then sit back down in the chair. | Baseline (study start) and at 2 months. |
| 6-Minute Walk Test (6MWT) | The test will be performed in a straight 30-meter corridor, following the standard protocol established by the American Thoracic Society. | Baseline (study start) and at 2 months. |
| Balance performance assessed using the TecnoBody D-Wall system | Balance performance will be evaluated using the TecnoBody D-Wall device (TecnoBody Srl, Bergamo, Italy). The primary balance outcome will be the stability index score obtained from the system. Higher scores indicate better balance performance. | Baseline (study start) and at 2 months. |
| Stride Length Assessed by TecnoBody Walker View | Stride length measured using the TecnoBody Walker View gait analysis system. | Baseline and at 2 months |
| Walking Speed Assessed by TecnoBody Walker View | Walking speed will be measured using the TecnoBody Walker View gait analysis system. Participants will walk at a comfortable pace along the walkway, and the average speed in meters per second will be recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease severity assessed by the Expanded Disability Status Scale (EDSS) | Disease severity will be assessed using the Expanded Disability Status Scale (EDSS), a standardized and validated scale for patients with multiple sclerosis. The EDSS score ranges from 0 to 10, with higher scores indicating greater disability and worse clinical status. | Baseline (study start) and at 2 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University | Izmir | Karşıyaka | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Baseline and at 2 months |
| Double Support Time Assessed by TecnoBody Walker View | Double support time, defined as the duration when both feet are in contact with the ground during gait, will be measured in seconds using the TecnoBody Walker View system. | Baseline and at 2 months |
| Gait Symmetry Index Assessed by TecnoBody Walker View | Gait symmetry will be assessed using the TecnoBody Walker View system by calculating the symmetry index from step length and stance duration for both legs, expressed as a percentage. | Baseline and at 2 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |