First Report of a New Exoskeleton in Incomplete Spinal Cord Injury

November 14, 2023 updated by: Ankara City Hospital Bilkent

First Report of a New Exoskeleton in Incomplete Spinal Cord Injury: FreeGait®

The goal of this clinical trial is to compare the effects of exoskeletal robotic therapy and conventional exercise therapy in incomplete spinal cord injury (SCI). The main questions it aims to answer are:

  • Is exoskeletal robotic therapy effective in improving functional ambulation in SCI?
  • Is exoskeletal robotic therapy effective in enhancing Activities of Daily Living in SCI?

Participants treated with either:

  • Exoskeletal robotic therapy along with conventional exercise therapy, or
  • Only conventional exercise therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Intensive walking practice is a task that requires performance above the limits of conventional therapy. As a solution, robot-assisted exoskeletons that allow walking on the ground are produced. The exoskeletons can allow the user to perform intense, targeted, and multi-repetitive movements and at the same time provide stability and balance during walking. In this study, a new robot-supported exoskeleton system was used for gait and balance rehabilitation. This study is important as the first clinical study of a new walking system. The primary aim of the study was to evaluate the effect of the FreeGait® exoskeleton system (BAMA Technology, Ankara, Türkiye) on gait parameters in patients with motor incomplete spinal cord injury. The secondary aim was to assess its impact on quality of life and independence.

Methods: Fourteen participants with incomplete spinal cord injury were included in the study. An average of 20.7 sessions of exoskeleton therapy was administered to the study group. Gait training was attempted to be diversified as much as possible during the exoskeleton training. 10MWT, Timed Up and Go Test (TUG), WISCI II, Berg Balance Scale (BBS), Visual Analogue Scale (VAS) for fear of falling, Spinal Cord Independence Measure (SCIM III), World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) were used for evaluation.

Results: WISCI II levels improved significantly in the study group (p = 0.031). Overground walking speed means calculated from 10MWT increased by 66%, twofold compared to the control group (p = 0.016, p = 0.063, respectively). The mobility subscale of SCIM III, the total SCIM III scores, and the WHOQOL-BREF physical health domain score increased significantly, contrary to the control group (p < 0.05). However, there was no difference in the mean change of all measurements between groups (p > 0.05).

Conclusions: Gait training with the new exoskeleton system contributes to functional walking skills. It is possible that the residual motor learning ability, together with the balance and compensation mechanisms, played a role in the outcome. It is also important that this improvement in functional mobility is reflected in ADLs. It can be supposed that walking in different patterns, and speeds gives a way to simulate daily living conditions, which is the basis of the achievements in this study.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Ankara City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • SCI below T4,
  • Patients with AIS (American Spinal Injury Association Impairment Scale) C or D injury,
  • Bilateral quadriceps femoris manual test scores ≥ 2,
  • Upper extremity manual muscle test scores = 5,
  • Participants with adequate spinal stabilization

Exclusion Criteria:

  • Severe spasticity (Modified Ashworth Scale ≥ 3),
  • Difference in leg length,
  • Pregnancy, osteoporosis,
  • Contracture, or limited range of motion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Participants were involved in exoskeletal robotic therapy three days a week and conventional therapy five days a week for a maximum of eight weeks.
Device: Exoskeletal robotic therapy for walking.
Exoskeletal robotic therapy for walking. Therapy sessions were scheduled for 40 minutes each. The study group performed exoskeleton walking and balance exercises 3 days a week.
Active Comparator: Control group
Participants were involved in conventional therapy five days a week for a maximum of eight weeks.
Other: Conventional exercise therapy
Conventional treatment consisted of walking and balance exercises, stretching, strengthening, and mobility exercises, for 40 minutes, 5 days a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking Index in Spinal Cord Injury II
Time Frame: 23 months
Walking Index in Spinal Cord Injury II for walking independence level assessment
23 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ten-Meter Walking Test
Time Frame: 23 months
Ten-Meter Walking Test for overground walking speed assessment
23 months
Timed Up and Go Test
Time Frame: 23 months
Timed Up and Go Test overground walking assessment
23 months
Berg Balance Scale
Time Frame: 23 months
Berg Balance Scale for balance assessment
23 months
Visual Analogue Scale
Time Frame: 23 months
Visual Analogue Scale (VAS) for fear of falling assessment
23 months
Spinal Cord Independence Measure (SCIM III)
Time Frame: 23 months
Spinal Cord Independence Measure (SCIM III) for activity of daily living assessment
23 months
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)
Time Frame: 23 months
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) for quality of life assessment
23 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Estimated)

November 17, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraCHBilkent-PMR-MSS-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injuries

Clinical Trials on Exoskeletal robotic therapy for walking.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe