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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04625309
Other study ID # SPORT DISABILITY
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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