- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04625309
Effect of Adaptive Sports After Acquired Physical Disability
Adaptive Sports for Individuals With a Physical Disability: Impact on the ICF Domains
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The present study will recruit participants based on a set of defined eligibility criteria, in adaptive sports clubs teams and in groups or associations of individuals with an acquired, and permanent, physical disability. Based on the presence or absence of a regular physical activity practice undertaken by the subjects who give their consent to participate in the study, they will be divided into two groups: one where individuals regularly practice a physical activity, and one where they do not.
A set of defined outcome measures (detailed in the "Outcome Measures"section) will be assessed in both groups.
The outcomes measures will be analysed statistically, using SPSS software. Depending on the nature of the variables (qualitative or quantitative), different tests will be performed. Normality will also be verified and will determine which statistical analysis will be carried out.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Brussels, Belgium, 1200
- Université Catholique de Louvain
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosed non-progressive spinal cord injury
- dependent on wheelchair for mobility
- more than 6 months since diagnosis of spinal injury
- able to understand and speak french
Exclusion Criteria:
- medical contra-indication to the testing
- cognitive deficiency which limits communication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sport
This group will be made up of subjects with a spinal cord injury that are actively participating in adaptive sports teams.
|
This will be the number of hours per week the subjects actively partake in adaptive sports teams.
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No Intervention: No sport
This group will be made up of subjects with a spinal cord injury that are not actively participating in any sports team.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain experienced during mobility
Time Frame: Throughout the study, an average of 4 months
|
This variable will be measured through a Likert scale out of 5, where greater values show more pain during mobility.
Subjects will be asked to rate presence, frequency and intensity of pain felt in the upper-limb when wheeling in their daily environments.
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Throughout the study, an average of 4 months
|
Fatigue Severity
Time Frame: Throughout the study, an average of 4 months
|
This variable will be measured using a validated questionnaire, "Fatigue Severity scale".
The minimum score is 9, and the maximum is 63.
The higher the score, the greater the fatigue severity (= worse outcome for the participant).
|
Throughout the study, an average of 4 months
|
Independence in mobility of daily living
Time Frame: Throughout the study, an average of 4 months
|
This variable will be measured using the validated "Spinal Cord Independence Measure -mobility".
Minimum score is 0 while maximum score is 40.
The higher the score, the better the independence of the participant (=better outcome).
|
Throughout the study, an average of 4 months
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Physical activity level
Time Frame: Through study completion, an average of 4 months
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Measured by a validated questionnaire, "Physical Activity Scale for Individuals with a Physical Disability".
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Through study completion, an average of 4 months
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Social participation
Time Frame: Throughout the study, an average of 4 months
|
This variable will be measured through the validated "Reintegration to Normal Living" index.
Minimum score is 0, maximum score is 100.
The higher the score, the better the outcome.
|
Throughout the study, an average of 4 months
|
Quality of Life: WHOQOL-BREF
Time Frame: Throughout the study, an average of 4 months
|
This variable will be measured through the World Health Organization's 8th version questionnaire, the WHOQOL-BREF.
Every one of the 4 domain can obtain a score ranging from 0 (minimum) to 100 (maximum).
The higher the score, the greater the quality of life.
|
Throughout the study, an average of 4 months
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patient's medical history
Time Frame: Throughout the study, an average of 4 months
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We will ask the subjects to report how many times they were hospitalised in the last six months and how many times they experienced a serious health-complication.
We will also ask them how many times per week they receive physiotherapy.
|
Throughout the study, an average of 4 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Louise Declerck, PT, Université Catholique de Louvain
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPORT DISABILITY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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