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Clinical Trials/NCT04625309
NCT04625309
Completed
N/A

Adaptive Sports for Individuals With a Physical Disability: Impact on the ICF Domains

Université Catholique de Louvain1 site in 1 country34 target enrollmentOctober 7, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
Université Catholique de Louvain
Enrollment
34
Locations
1
Primary Endpoint
Pain experienced during mobility
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 7, 2020
End Date
September 7, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

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).

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).

Physical activity level

Time Frame: Through study completion, an average of 4 months

Measured by a validated questionnaire, "Physical Activity Scale for Individuals with a Physical Disability".

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.

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.

patient's medical history

Time Frame: Throughout the study, an average of 4 months

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.

Study Sites (1)

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