Effects of Power Wheelchair Soccer for Individuals Presenting With Physical Impairments (chair-soccer)

February 6, 2024 updated by: Université Catholique de Louvain

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Power wheelchair soccer
soccer game performed with a wheelchair
Other: Power wheelchair soccer
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
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.
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.
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.
Throughout the entire study (an average of 8 months)
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.
Throughout the entire study (an average of 8 months)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Throughout the entire study (an average of 8 months)
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)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.
Throughout the entire study (an average of 8 months)
Demographic variables
Time Frame: Throughout the entire study (an average of 8 months)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FOOT FAUTEUIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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