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NCT Number: NCT04625309

Effect of Adaptive Sports After Acquired Physical Disability

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Sports Physical Therapy Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université catholique de Louvain

Brussels, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adaptive sports

Other

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

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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".

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2020
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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