Clinical trial NCT06137456: First Report of a New Exoskeleton in Incomplete Spinal Cord Injury
Official title: First Report of a New Exoskeleton in Incomplete Spinal Cord Injury: FreeGait®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Walking, Difficulty
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Walking Index in Spinal Cord Injury II
timeFrame: 23 months
Secondary outcomes:
measure: Ten-Meter Walking Test
timeFrame: 23 months
measure: Timed Up and Go Test
timeFrame: 23 months
measure: Berg Balance Scale
timeFrame: 23 months
measure: Visual Analogue Scale
timeFrame: 23 months
measure: Spinal Cord Independence Measure (SCIM III)
timeFrame: 23 months
measure: World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)
timeFrame: 23 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
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