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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Hybrid Assistive Limb (HAL)

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.

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Karşıyaka
    • Izmir, Karşıyaka, Turkey (Türkiye)
      • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• No previous robotic rehabilitation.
• Completion of the 10-meter walk test.
• Mini mental status score ≥24.
• MASS score <2.
• EDSS <6.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2025
• Primary Completion (Actual): December 9, 2025
• Study Completion (Estimated): February 9, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Multiple sclerosis; exoskeleton
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: MOzkeskin25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No