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Clinical Trials/NCT06137443
NCT06137443
Completed
Not Applicable

Enhancing Balance and Mobility in Incomplete Spinal Cord Injury With an Overground Gait Trainer

Ankara City Hospital Bilkent1 site in 1 country5 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
Ankara City Hospital Bilkent
Enrollment
5
Locations
1
Primary Endpoint
Berg Balance Scale
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to compare the effects of balance therapy with an overground gait trainer in incomplete spinal cord injury (SCI). The main questions it aims to answer are:

  • Is balance therapy with an overground gait trainer effective in improving functional ambulation in SCI?
  • Is balance therapy with an overground gait trainer effective in enhancing Activities of Daily Living in SCI?

Participants treated with either:

• Overground gait trainer along with conventional exercise therapy

Detailed Description

Background: Spinal Cord Injury (SCI) and similar pathologies not only negatively affect a person's ability to walk but also have adverse effects on their participation in social, vocational, and recreational activities. The correction of walking impairments resulting from SCI is one of the most important goals of rehabilitation, as it is essential for a person's social and vocational integration. When considering balance function, the use of challenging balance and walking exercises at an adequate level is necessary to trigger motor learning. Ensuring the patient's safety is the primary priority when using advanced balance and walking exercises based on the patient's current condition. In this study, Andago V2.0 (Hocoma AG, Volketswil, Switzerland) has been preferred for ensuring safety by adapting to patient movements. The main objective of the study was to assess the impact of Andago on balance in patients with motor incomplete SCI. The secondary aim was to evaluate its influence on quality of life and independence. Methods: The study included five participants who were over 18 years of age and had experienced a spinal injury within the past year. These participants were classified as AIS D (American Spinal Injury Association Impairment Scale). Patients underwent eight-week treatment, with walking and balance exercises on Andago performed three days a week. In addition, conventional in-bed exercises, including stretching, strengthening, and mobility exercises, were administered for 40 minutes, two days a week. Modified Borg Scale (MBS), Ten-Meter Walking Test (10MWT), Timed Up and Go Test (TUG), Walking Index in Spinal Cord Injury II (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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
November 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Spinal Cord Injured below T4
  • Time from injury \< 1 year
  • D level on AIS (American Spinal Injury Association Impairment Scale)
  • Patients with spinal stabilization

Exclusion Criteria

  • Osteoporosis
  • An implanted electronic device
  • other neurological diseases
  • Cardio-pulmonary diseases
  • Orthopedic diseases

Outcomes

Primary Outcomes

Berg Balance Scale

Time Frame: 11 months

Berg Balance Scale for balance assessment

Secondary Outcomes

  • Ten-Meter Walking Test(11 months)
  • Walking Index in Spinal Cord Injury II(11 months)
  • Visual Analogue Scale(11 months)
  • Timed Up and Go Test(11 months)
  • World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)(11 months)
  • Modified Borg Scale(11 months)
  • Spinal Cord Independence Measure (SCIM III)(11 months)

Study Sites (1)

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