- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06259643
Effects of Power Wheelchair Soccer for Individuals Presenting With Physical Impairments (chair-soccer)
Clinical and Psychosocial Impact of Power Wheelchair Soccer for Individuals Presenting With Physical Impairments
This study is a prospective interventional study. It will be conducted at a single center with participants who have neuromotor impairments. The primary objective is to assess and measure the clinical and psychosocial effects of a season of power wheelchair soccer among its participants presenting with severe motor impairments due to neuromuscular lesion.
A maximum of twenty participants will be recruited and included in the same group. Data collection will be performed before, during, and after the wheelchair soccer season. The study will span the entire season, starting in November 2023 and ending in June 2024.
Clinical and psychosocial assessments will be conducted every 3 months. Each assessment session will last 2 hours per participant. Before and after the wheelchair soccer season matches, we will evaluate parameters related to the physical load of the sport. These evaluations will last 10 minutes per participant.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Louise Declerck, PT
- Phone Number: +32 0476480314
- Email: louise.declerck@uclouvain.be
Study Locations
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Brussels, Belgium, 1200
- Recruiting
- Neuromusculoskeletal Lab
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Contact:
- Louise Declerck, PT
- Phone Number: +32 0476480314
- Email: louise.declerck@uclouvain.be
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being a male or female between the ages of 12 and 50.
- Presenting with severe motor impairments due to neuromotor and/or musculoskeletal impairment.
- Using a power wheelchair in everyday life.
- Being part of a power wheelchair soccer team.
- Committing to participating in the 2023-2024 season of their sport within the team.
Exclusion Criteria:
- Practicing another adaptive sport outside of power wheelchair soccer in a regular way (once a week or more).
- Occasionally practicing power wheelchair soccer (twice a month or less).
- Presenting with severe cognitive impairments affecting understanding of instructions on how to answer questionnaires and undertake tests.
Presenting with contraindications towards the practice of an adaptive sport such as power wheelchair soccer.
- Participating in another study at baseline.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Power wheelchair soccer
soccer game performed with a wheelchair
|
Participants will practice power wheelchair soccer during the course of the power wheelchair soccer season (starting in November 2023 and ending in June 2024).
Sessions are given once a week, by a coach with experience in this adaptive sport.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: Throughout the entire study (an average of 8 months)
|
Balance will be measured using the Trunk control measurement scale.
Scores range from 0 to 58, where a higher score displays better trunk control.
|
Throughout the entire study (an average of 8 months)
|
|
Balance
Time Frame: Throughout the entire study (an average of 8 months)
|
Balance will be measured using the Level of sitting scale.
Levels range from 1 to 8, where a higher score demonstrates better sitting balance.
|
Throughout the entire study (an average of 8 months)
|
|
Balance
Time Frame: Throughout the entire study (an average of 8 months)
|
Balance will be measured using the function section of the Seated Postural Control measure.
Scores range from 12 to 48, where a higher score is attributed to individuals with better postural control.
|
Throughout the entire study (an average of 8 months)
|
|
Sensorimotor impairment
Time Frame: Throughout the entire study (an average of 8 months)
|
Sensorimotor impairment will be measured by the Fugl-Meyer assessment.
|
Throughout the entire study (an average of 8 months)
|
|
Hyperactivity of the muscles
Time Frame: Throughout the entire study (an average of 8 months)
|
Hyperactivity of the muscles will be measured using the Australian Spasticity Assessment scale of the upper-limb main muscle groups.
Scores per muscle groups range from 0 to 4, where a higher score represents greater spasticity and more hyperactivity in the muscle group.
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Throughout the entire study (an average of 8 months)
|
|
Hyperactivity of the muscles
Time Frame: Throughout the entire study (an average of 8 months)
|
Hyperactivity of the muscles will be measured using the Penn Spasm Frequency Scale.
Scores range from 0 to 4, where a higher score represents more frequent spasms and hyperactivity of the muscles.
|
Throughout the entire study (an average of 8 months)
|
|
Pain
Time Frame: Throughout the entire study (an average of 8 months)
|
Pain perceived by the participants in their daily life will be measured using the PROMIS pain-pediatric Short Form V2 questionnaire.
Scores range from 8 to 40, where a higher score displays more pain in everyday life.
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Throughout the entire study (an average of 8 months)
|
|
Quality of life
Time Frame: Throughout the entire study (an average of 8 months)
|
Quality of life will be assessed using the KIDSCREEN 27 questionnaire.
Scores range from 10 and 50, where 50 represents a very high health-related quality of life.
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Throughout the entire study (an average of 8 months)
|
|
Skills to manage and move power wheelchair
Time Frame: Throughout the entire study (an average of 8 months)
|
Skills to manage and move power wheelchair will be assessed by the Wheelchair Skills Test Questionnaire version 4.2.
Scores range from 0 to 100%, where a greater percentage represents better skills.
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Throughout the entire study (an average of 8 months)
|
|
Social participation
Time Frame: Throughout the entire study (an average of 8 months)
|
Social participation will be assessed using the Questionnaire of young people's participation.Scores range from 0 to 239, where a higher score displays greater social participation.
|
Throughout the entire study (an average of 8 months)
|
|
Autonomy during activities of daily life
Time Frame: Throughout the entire study (an average of 8 months)
|
Autonomy during activities of daily life will be assessed using the Impact on participation and autonomy questionnaire.
A participation score (range: 30-155) and a problem score (0-16) are produced by summing items in each scale.
For both, a higher score represent poorer autonomy and more severe difficulty.
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Throughout the entire study (an average of 8 months)
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Strength of the upper-limbs
Time Frame: Throughout the entire study (an average of 8 months)
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Strength of the main muscle groups of the upper-limb will be measured using a Microfet 2 dynamometer.
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Throughout the entire study (an average of 8 months)
|
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Passive range of motion the upper-limbs
Time Frame: Throughout the entire study (an average of 8 months)
|
Passive range of motion of the upper-limbs will be measured using a goniometer.
|
Throughout the entire study (an average of 8 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body temperature
Time Frame: Throughout the entire study (an average of 8 months)
|
Body temperature will be evaluated using a tympanic thermometer.
|
Throughout the entire study (an average of 8 months)
|
|
Blood oxygen saturation
Time Frame: Throughout the entire study (an average of 8 months)
|
Blood oxygen saturation will be evaluated using a pulse oximeter.
|
Throughout the entire study (an average of 8 months)
|
|
Heart beat rate
Time Frame: Throughout the entire study (an average of 8 months)
|
Heart beat rate will be evaluated using a heart rate monitor.
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Throughout the entire study (an average of 8 months)
|
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Blood pressure
Time Frame: Throughout the entire study (an average of 8 months)
|
Blood pressure will be evaluated on the left upper-arm with a tensiometer.
Both systolic and diastolic pressure will be recorded.
|
Throughout the entire study (an average of 8 months)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction with the power wheelchair soccer practices
Time Frame: Throughout the entire study (an average of 8 months)
|
Satisfaction with the power wheelchair soccer practices will be evaluated on a 10 point Likert-scale.
A higher score displays greater satisfaction with the practices.
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Throughout the entire study (an average of 8 months)
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Demographic variables
Time Frame: Throughout the entire study (an average of 8 months)
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Participants' age, sex, origin of physical impairment, motor impairment severity, hours of physical therapy per week, as well as motor impairment severity, will be collected.
|
Throughout the entire study (an average of 8 months)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FOOT FAUTEUIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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