Study on Rehabilitation Exercise Program for Community-based Spinal Cord Injury Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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Spinal cord injury is classified into complete paralysis and incomplete paralysis depending on the degree of spinal cord damage. In the case of complete paralysis, functional recovery is almost impossible, but in the case of incomplete paralysis, the level of functional recovery is determined through active rehabilitation exercises. In the past, most spinal cord injuries were traumatic, but due to the decrease in accidents, traumatic spinal cord injuries have decreased, and the incidence of non-traumatic spinal cord injuries (spinal cord disorders) has increased significantly due to aging. Most people with spinal cord injuries have difficulty performing appropriate rehabilitation exercises in the local community due to mobility impairments and limitations in daily activities. Spinal cord injury patients who participate in existing disabled sports are limited to some (relatively young) patients who have received epilepsy diagnosis. Individualized rehabilitation exercises based on each patient's personalized protocol are necessary, and sufficient functional recovery can be achieved through this approach. It is predicted that rehabilitation exercises through a protocol will improve cardiac and respiratory function and quality of life. Rehabilitation exercises for spinal cord injury patients should be applied based on accurate evaluation of function, and assessment of exercise-related risk factors should also be conducted. Customized exercise programs based on individual exercise function evaluations should be applied, but currently there is a lack of rehabilitation exercise programs that consider this. Additionally, risk factor evaluations related to exercise are not being conducted. Therefore, the development and application of patient-tailored community-based rehabilitation exercise programs for spinal cord injury patients that include risk factor evaluations and functional assessments are necessary.

Official Title
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Study on the Safety and Effectiveness of a Rehabilitation Exercise Program for Community-based Spinal Cord Injury Patients

Conditions
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Spinal Cord Injuries, Rehabilitation, Exercise Program

Intervention / Treatment
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* Behavioral: Structured rehabilitation exercise program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>A 20-session structured rehabilitation exercise program in those with spinal cord injuries | Behavioral: Structured rehabilitation exercise program<br>* Stretching (10 mins): neck, shoulder, wrist, back; Aerobic exercise (20 mins): cycle ergometer, wheelchair run; Strengthening exercise (15 mins): shoulder press, chest press, front raise, biceps curl, lateral raise, bent over rowing or rowing, bent over lateral raise, triceps extension; Balance training (5 mins); Stretching exercise (10 mins)<br>|
| No Intervention: Control group<br>No exercise intervention in those with spinal cord injuries | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 6 minute walk distance | Sub-maximal exercise test used to assess aerobic capacity and endurance | Evaluation after average 2 months of exercise program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Sit to stand test | Testing leg strength and endurance | Baseline evaluation and follow-up evaluation after average 2 months of exercise program | 
| 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 | 
| 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 |