Effect of Adaptive Sports After Acquired Physical Disability
Primary Purpose
Spinal Cord Injuries, Sports Physical Therapy
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Adaptive sports
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility Criteria
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
Sites / Locations
- Université catholique de Louvain
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sport
No sport
Arm Description
This group will be made up of subjects with a spinal cord injury that are actively participating in adaptive sports teams.
This group will be made up of subjects with a spinal cord injury that are not actively participating in any sports team.
Outcomes
Primary Outcome Measures
Pain experienced during mobility
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.
Fatigue Severity
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).
Independence in mobility of daily living
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).
Physical activity level
Measured by a validated questionnaire, "Physical Activity Scale for Individuals with a Physical Disability".
Social participation
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.
Quality of Life: WHOQOL-BREF
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.
patient's medical history
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04625309
First Posted
February 20, 2020
Last Updated
September 27, 2021
Sponsor
Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT04625309
Brief Title
Effect of Adaptive Sports After Acquired Physical Disability
Official Title
Adaptive Sports for Individuals With a Physical Disability: Impact on the ICF Domains
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
July 7, 2021 (Actual)
Study Completion Date
September 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain
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
This study is a cross-sectional trial which aims to evaluate the effect of practicing a physical activity on different domains of the ICF among individuals with an acquired physical disability. Two different groups of individuals with a spinal cord injury will be enrolled: one composed of subjects who manage to reach the WHO's recommendations regarding physical activity, and the other of subjects who do not.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Sports Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sport
Arm Type
Experimental
Arm Description
This group will be made up of subjects with a spinal cord injury that are actively participating in adaptive sports teams.
Arm Title
No sport
Arm Type
No Intervention
Arm Description
This group will be made up of subjects with a spinal cord injury that are not actively participating in any sports team.
Intervention Type
Other
Intervention Name(s)
Adaptive sports
Intervention Description
This will be the number of hours per week the subjects actively partake in adaptive sports teams.
Primary Outcome Measure Information:
Title
Pain experienced during mobility
Description
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.
Time Frame
Throughout the study, an average of 4 months
Title
Fatigue Severity
Description
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).
Time Frame
Throughout the study, an average of 4 months
Title
Independence in mobility of daily living
Description
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).
Time Frame
Throughout the study, an average of 4 months
Title
Physical activity level
Description
Measured by a validated questionnaire, "Physical Activity Scale for Individuals with a Physical Disability".
Time Frame
Through study completion, an average of 4 months
Title
Social participation
Description
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.
Time Frame
Throughout the study, an average of 4 months
Title
Quality of Life: WHOQOL-BREF
Description
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.
Time Frame
Throughout the study, an average of 4 months
Title
patient's medical history
Description
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.
Time Frame
Throughout the study, an average of 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Declerck, PT
Organizational Affiliation
Université Catholique de Louvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université catholique de Louvain
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Adaptive Sports After Acquired Physical Disability
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