Neuromuscular Diseaseschair-soccerNCT06259643
Effects of Power Wheelchair Soccer for Individuals Presenting With Physical Impairments
A study testing Power wheelchair soccer in people with Neuromuscular Diseases and Cerebral Palsy, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Neuromuscular Diseases, Cerebral Palsy
- What is being tested?
- Power wheelchair soccer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2023to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Neuromusculoskeletal Lab
Brussels, 1200
Louise Declerck, PT, 0476480314 ext. +32, louise.declerck@uclouvain.be
About this study
Official title: 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.
- Conditions
- Neuromuscular Diseases, Cerebral Palsy
- Being tested
- Power wheelchair soccer
- Medical subject headings
- Neuromuscular Diseases, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power wheelchair soccerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Power wheelchair soccer | Experimental | soccer game performed with a wheelchair Receives: Other: Power wheelchair soccer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Balance will be measured using the Trunk control measurement scale. Scores range from 0 to 58, where a higher score displays better trunk control.
Measured: Throughout the entire study (an average of 8 months)
Balance
Balance will be measured using the Level of sitting scale. Levels range from 1 to 8, where a higher score demonstrates better sitting balance.
Measured: Throughout the entire study (an average of 8 months)
Balance
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.
Measured: Throughout the entire study (an average of 8 months)
Sensorimotor impairment
Sensorimotor impairment will be measured by the Fugl-Meyer assessment.
Measured: Throughout the entire study (an average of 8 months)
Hyperactivity of the muscles
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.
Measured: Throughout the entire study (an average of 8 months)
Hyperactivity of the muscles
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.
Measured: Throughout the entire study (an average of 8 months)
Pain
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.
Measured: Throughout the entire study (an average of 8 months)
Quality of life
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.
Measured: Throughout the entire study (an average of 8 months)
Skills to manage and move power wheelchair
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.
Measured: Throughout the entire study (an average of 8 months)
Social participation
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.
Measured: Throughout the entire study (an average of 8 months)
Autonomy during activities of daily life
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.
Measured: Throughout the entire study (an average of 8 months)
Strength of the upper-limbs
Strength of the main muscle groups of the upper-limb will be measured using a Microfet 2 dynamometer.
Measured: Throughout the entire study (an average of 8 months)
Passive range of motion the upper-limbs
Passive range of motion of the upper-limbs will be measured using a goniometer.
Measured: Throughout the entire study (an average of 8 months)
Secondary outcomes (4)
Body temperature
Body temperature will be evaluated using a tympanic thermometer.
Measured: Throughout the entire study (an average of 8 months)
Blood oxygen saturation
Blood oxygen saturation will be evaluated using a pulse oximeter.
Measured: Throughout the entire study (an average of 8 months)
Heart beat rate
Heart beat rate will be evaluated using a heart rate monitor.
Measured: Throughout the entire study (an average of 8 months)
Blood pressure
Blood pressure will be evaluated on the left upper-arm with a tensiometer. Both systolic and diastolic pressure will be recorded.
Measured: Throughout the entire study (an average of 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Nov 2023
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259643
- Sponsor's protocol ID
- FOOT FAUTEUIL
- Acronym
- chair-soccer
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Psychosocial Impact of Power Wheelchair Soccer for Individuals Presenting With Physical Impairments
- ClinicalTrials.gov ID
- NCT06259643
- Acronym / sponsor ID
- chair-soccer / FOOT FAUTEUIL
- Conditions
- Neuromuscular Diseases, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Power wheelchair soccer | Experimental | Other: Power wheelchair soccersoccer game performed with a wheelchair |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power wheelchair soccerParticipants 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. | Other | Power wheelchair soccer |
Primary outcome
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.
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.
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.
Sensorimotor impairment
Time frame: Throughout the entire study (an average of 8 months)
Sensorimotor impairment will be measured by the Fugl-Meyer assessment.
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.
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.
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.
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.
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.
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.
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.
Strength of the upper-limbs
Time frame: Throughout the entire study (an average of 8 months)
Strength of the main muscle groups of the upper-limb will be measured using a Microfet 2 dynamometer.
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.
4 secondary outcomes
Body temperature
Time frame: Throughout the entire study (an average of 8 months)
Blood oxygen saturation
Time frame: Throughout the entire study (an average of 8 months)
Heart beat rate
Time frame: Throughout the entire study (an average of 8 months)
Blood pressure
Time frame: Throughout the entire study (an average of 8 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power wheelchair soccer in people with Neuromuscular Diseases and Cerebral Palsy, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louise Declerck, PT (0476480314 ext. +32, louise.declerck@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Throughout the entire study (an average of 8 months)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.