Spinal Cord Injuries Clinical Trial
Official title:
Study on the Safety and Effectiveness of a Rehabilitation Exercise Program for Community-based Spinal Cord Injury Patients
In the case of spinal cord injury, patients have shown a passive attitude towards participating in leisure sports or exercise programs, and there is a lack of suitable guidelines or experience in the local community for coaching exercise and sports for spinal cord injury patients, which makes coaches feel burdened when coaching these patients. Therefore, in this study, a suitable comprehensive exercise program will be designed and prescribed for patients who reside in the local community and want to participate in leisure sports, and the effectiveness and safety of the program will be verified. Based on the results, the aim of the study is to provide evidence that spinal cord injury patients can exercise safely and confidently in the local community in the future.
Status | Not yet recruiting |
Enrollment | 115 |
Est. completion date | December 31, 2023 |
Est. primary completion date | October 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Spinal cord injury patients who are 19 years old or above and residing in the local community - A person who is unable to walk independently for more than 10 meters without assistance from others - A person whose elbow joint flexor muscle strength level is MMT 3 (Fair) or higher Exclusion Criteria: - Individuals who have difficulty understanding the exercise program or expressing their symptoms - Individuals who cannot participate in the intervention exercise program due to serious cardiovascular diseases - Individuals who are deemed unsuitable for this study by a specialist in rehabilitation medicine due to other medical conditions |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Pusan National University Yangsan Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EuroQol 5 Dimension 5 Level | Self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression | Evaluation after average 2 months of exercise program | |
Primary | 6 minute walk distance | Sub-maximal exercise test used to assess aerobic capacity and endurance | Evaluation after average 2 months of exercise program | |
Secondary | Berg balance scale | Testing tool with high validity and reliability used to measure balance | Baseline evaluation and follow-up evaluation after average 2 months of exercise program | |
Secondary | Timed up and go test | Reliable and valid test for quantifying functional mobility | Baseline evaluation and follow-up evaluation after average 2 months of exercise program | |
Secondary | Grip strength | Force applied by the hand to pull on or suspend from objects | Baseline evaluation and follow-up evaluation after average 2 months of exercise program | |
Secondary | Sit to stand test | Testing leg strength and endurance | Baseline evaluation and follow-up evaluation after average 2 months of exercise program | |
Secondary | Sit and reach test | Test to measure hamstring and low back flexibility | Baseline evaluation and follow-up evaluation after average 2 months of exercise program | |
Secondary | Fat-free mass from bioelectrical impedance analysis | A method used to measure the components of the body | Baseline evaluation and follow-up evaluation after average 2 months of exercise program |
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