search
Back to results

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

Primary Purpose

Spinal Cord Injuries, Rehabilitation, Exercise Program

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Structured rehabilitation exercise program
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

    A 20-session structured rehabilitation exercise program in those with spinal cord injuries

    No exercise intervention in those with spinal cord injuries

    Outcomes

    Primary Outcome Measures

    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
    6 minute walk distance
    Sub-maximal exercise test used to assess aerobic capacity and endurance

    Secondary Outcome Measures

    Berg balance scale
    Testing tool with high validity and reliability used to measure balance
    Timed up and go test
    Reliable and valid test for quantifying functional mobility
    Grip strength
    Force applied by the hand to pull on or suspend from objects
    Sit to stand test
    Testing leg strength and endurance
    Sit and reach test
    Test to measure hamstring and low back flexibility
    Fat-free mass from bioelectrical impedance analysis
    A method used to measure the components of the body

    Full Information

    First Posted
    April 27, 2023
    Last Updated
    May 17, 2023
    Sponsor
    Pusan National University Yangsan Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05878145
    Brief Title
    Study on Rehabilitation Exercise Program for Community-based Spinal Cord Injury Patients
    Official Title
    Study on the Safety and Effectiveness of a Rehabilitation Exercise Program for Community-based Spinal Cord Injury Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    October 30, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pusan National University Yangsan Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injuries, Rehabilitation, Exercise Program

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    115 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    A 20-session structured rehabilitation exercise program in those with spinal cord injuries
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    No exercise intervention in those with spinal cord injuries
    Intervention Type
    Behavioral
    Intervention Name(s)
    Structured rehabilitation exercise program
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    EuroQol 5 Dimension 5 Level
    Description
    Self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
    Time Frame
    Evaluation after average 2 months of exercise program
    Title
    6 minute walk distance
    Description
    Sub-maximal exercise test used to assess aerobic capacity and endurance
    Time Frame
    Evaluation after average 2 months of exercise program
    Secondary Outcome Measure Information:
    Title
    Berg balance scale
    Description
    Testing tool with high validity and reliability used to measure balance
    Time Frame
    Baseline evaluation and follow-up evaluation after average 2 months of exercise program
    Title
    Timed up and go test
    Description
    Reliable and valid test for quantifying functional mobility
    Time Frame
    Baseline evaluation and follow-up evaluation after average 2 months of exercise program
    Title
    Grip strength
    Description
    Force applied by the hand to pull on or suspend from objects
    Time Frame
    Baseline evaluation and follow-up evaluation after average 2 months of exercise program
    Title
    Sit to stand test
    Description
    Testing leg strength and endurance
    Time Frame
    Baseline evaluation and follow-up evaluation after average 2 months of exercise program
    Title
    Sit and reach test
    Description
    Test to measure hamstring and low back flexibility
    Time Frame
    Baseline evaluation and follow-up evaluation after average 2 months of exercise program
    Title
    Fat-free mass from bioelectrical impedance analysis
    Description
    A method used to measure the components of the body
    Time Frame
    Baseline evaluation and follow-up evaluation after average 2 months of exercise program

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sungchul Huh, PhD
    Phone
    +82-55-360-4250
    Email
    dr.huhsc@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yoon A Kim, Bachelor
    Phone
    +82-55-360-4250
    Email
    kyoona1289@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sung-Hwa Ko, PhD
    Organizational Affiliation
    Pusan National University Yangsan Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs