Effect of Hybrid Assistive Limb (HAL) Application on Locomotor Function and Balance Parameters in Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- 10-Meter Walk Test (10mWT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No previous robotic rehabilitation.
- •Completion of the 10-meter walk test.
- •Mini mental status score ≥
- •MASS score <
- •EDSS <6.
排除标准
- •History of serious degenerative disease.
- •Presence of open wounds.
- •History of thoracic surgery.
- •Chronic respiratory diseases.
- •Presence of unstable cardiovascular disease.
- •Medical conditions that prevent mobilization.
研究组 & 干预措施
MS
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.
干预措施: Hybrid Assistive Limb (HAL) (Device)
结局指标
主要结局
10-Meter Walk Test (10mWT)
时间窗: Baseline (study start) and at 2 months.
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.
Timed Up and Go Test (TUG)
时间窗: Baseline (study start) and at 2 months.
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.
6-Minute Walk Test (6MWT)
时间窗: Baseline (study start) and at 2 months.
The test will be performed in a straight 30-meter corridor, following the standard protocol established by the American Thoracic Society.
Balance performance assessed using the TecnoBody D-Wall system
时间窗: Baseline (study start) and at 2 months.
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.
Stride Length Assessed by TecnoBody Walker View
时间窗: Baseline and at 2 months
Stride length measured using the TecnoBody Walker View gait analysis system.
Walking Speed Assessed by TecnoBody Walker View
时间窗: Baseline and at 2 months
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.
Double Support Time Assessed by TecnoBody Walker View
时间窗: Baseline and at 2 months
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.
Gait Symmetry Index Assessed by TecnoBody Walker View
时间窗: Baseline and at 2 months
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.
次要结局
- Disease severity assessed by the Expanded Disability Status Scale (EDSS)(Baseline (study start) and at 2 months.)
研究者
Mehmet Ozkeskin
Associate Professor of Physical Therapy and Rehabilitation
Ege University