Hybrid Assistive Limb Application in Multiple Sclerosis Patients

NCT07326852 | Enrolling By Invitation

• 1 other identifier: MOzkeskin25
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; exoskeleton

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Disease severity assessed by the Expanded Disability Status Scale (EDSS)

  Baseline (study start) and at 2 months.

Study Arms (1)

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.

Device: Hybrid Assistive Limb (HAL)

Interventions

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.

MS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Karşıyaka, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy and Rehabilitation

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: January 8, 2026
• Study Start: October 8, 2025
• Primary Completion: December 9, 2025
• Study Completion: February 9, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

TU (1)