Enhancing Balance and Mobility in Incomplete Spinal Cord Injury

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spinal Cord Injuries, Walking, Difficulty

Intervention / Treatment
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* Device: Balance Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balance Training<br>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 treatment for eight weeks, 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. | Device: Balance Training<br>* Patients underwent treatment for eight weeks, 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale | Berg Balance Scale for balance assessment | 11 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ten-Meter Walking Test | Ten-Meter Walking Test for overground walking speed assessment | 11 months | 
| Timed Up and Go Test | Timed Up and Go Test overground walking assessment | 11 months | 
| Walking Index in Spinal Cord Injury II | Walking Index in Spinal Cord Injury II for walking independence level assessment | 11 months | 
| Modified Borg Scale | Modified Borg Scale for subjective fatigue assessment | 11 months | 
| Visual Analogue Scale | Visual Analogue Scale (VAS) for fear of falling assessment | 11 months | 
| Spinal Cord Independence Measure (SCIM III) | Spinal Cord Independence Measure (SCIM III) for activity of daily living assessment | 11 months | 
| World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) | World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) for quality of life assessment | 11 months |