Enhancing Balance and Mobility in Incomplete Spinal Cord Injury
- Conditions
- Spinal Cord InjuriesWalking, Difficulty
- Interventions
- Device: Balance Training
- Registration Number
- NCT06137443
- Lead Sponsor
- Ankara City Hospital Bilkent
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- Spinal Cord Injured below T4
- Time from injury < 1 year
- D level on AIS (American Spinal Injury Association Impairment Scale)
- Patients with spinal stabilization
- Osteoporosis
- An implanted electronic device
- other neurological diseases
- Cardio-pulmonary diseases
- Orthopedic diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Balance Training Balance Training 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.
- Primary Outcome Measures
Name Time Method Berg Balance Scale 11 months Berg Balance Scale for balance assessment
- Secondary Outcome Measures
Name Time Method Ten-Meter Walking Test 11 months Ten-Meter Walking Test for overground walking speed assessment
Walking Index in Spinal Cord Injury II 11 months Walking Index in Spinal Cord Injury II for walking independence level assessment
Visual Analogue Scale 11 months Visual Analogue Scale (VAS) for fear of falling assessment
Timed Up and Go Test 11 months Timed Up and Go Test overground walking assessment
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) 11 months World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) for quality of life assessment
Spinal Cord Independence Measure (SCIM III) 11 months Spinal Cord Independence Measure (SCIM III) for activity of daily living assessment
Modified Borg Scale 11 months Modified Borg Scale for subjective fatigue assessment
Trial Locations
- Locations (1)
Ankara City Hospital
🇹🇷Ankara, Turkey