NCT07326852

Hybrid Assistive Limb Application in Multiple Sclerosis Patients

Effect of Hybrid Assistive Limb (HAL) Application on Locomotor Function and Balance Parameters in Multiple Sclerosis Patients

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Ege University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	Hybrid Assistive Limb (HAL)	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.

Timeline

• Start date: 2025-10-08
• Primary completion: 2025-12-09
• Completion: 2026-02-09
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: Turkey (Türkiye)