Effect of Adaptive Sports After Acquired Physical Disability

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04625309
• Other study ID #: SPORT DISABILITY
• Status: Completed
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: September 7, 2021

Study information

• Verified date: September 2021
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 7, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Sports Physical Therapy

Intervention

Other:
• Adaptive sports
This will be the number of hours per week the subjects actively partake in adaptive sports teams.

Locations

Country	Name	City	State
Belgium	Université catholique de Louvain	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Throughout the study, an average of 4 months
Primary	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).	Throughout the study, an average of 4 months
Primary	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).	Throughout the study, an average of 4 months
Primary	Physical activity level	Measured by a validated questionnaire, "Physical Activity Scale for Individuals with a Physical Disability".	Through study completion, an average of 4 months
Primary	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.	Throughout the study, an average of 4 months
Primary	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.	Throughout the study, an average of 4 months
Primary	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.	Throughout the study, an average of 4 months