First Report of a New Exoskeleton in Incomplete Spinal Cord Injury

Sponsor

Ankara City Hospital Bilkent (Other)

Overall Status

Completed

CT.gov ID

NCT06137456

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries Walking, Difficulty	Device: Exoskeletal robotic therapy for walking. Other: Conventional exercise therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Actual Primary Completion Date :

Nov 1, 2023

Actual Study Completion Date :

Nov 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Walking Index in Spinal Cord Injury II [23 months]
Walking Index in Spinal Cord Injury II for walking independence level assessment

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara City Hospital	Ankara		Turkey	06800

Sponsors and Collaborators

Ankara City Hospital Bilkent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Ankara City Hospital Bilkent

ClinicalTrials.gov Identifier:

NCT06137456

Other Study ID Numbers:

AnkaraCHBilkent-PMR-MSS-02

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Spinal Cord Injuries

Mobility Limitation

Wounds and Injuries

Study Results

No Results Posted as of Nov 18, 2023