Clinical trial NCT04625309: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Sports Physical Therapy
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain experienced during mobility
timeFrame: Throughout the study, an average of 4 months
measure: Fatigue Severity
timeFrame: Throughout the study, an average of 4 months
measure: Independence in mobility of daily living
timeFrame: Throughout the study, an average of 4 months
measure: Physical activity level
timeFrame: Through study completion, an average of 4 months
measure: Social participation
timeFrame: Throughout the study, an average of 4 months
measure: Quality of Life: WHOQOL-BREF
timeFrame: Throughout the study, an average of 4 months
measure: patient's medical history
timeFrame: Throughout the study, an average of 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Université catholique de Louvain
Study officials:
affiliation: Université Catholique de Louvain
name: Louise Declerck, PT
role: PRINCIPAL_INVESTIGATOR
References: