Effects of Power Wheelchair Soccer for Individuals Presenting With Physical Impairments

Cerebral Palsy Clinical Trial

— chair-soccer  

Official title:

Clinical and Psychosocial Impact of Power Wheelchair Soccer for Individuals Presenting With Physical Impairments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06259643
• Other study ID #: FOOT FAUTEUIL
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: February 2024
• Source: Université Catholique de Louvain
• Contact: Louise Declerck, PT
• Phone: 0476480314
• Email: louise.declerck[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Neuromuscular Diseases

Intervention

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.

Locations

Country	Name	City	State
Belgium	Neuromusculoskeletal Lab	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
Other	Satisfaction with the power wheelchair soccer practices	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)
Other	Demographic variables	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)
Primary	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.	Throughout the entire study (an average of 8 months)
Primary	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.	Throughout the entire study (an average of 8 months)
Primary	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.	Throughout the entire study (an average of 8 months)
Primary	Sensorimotor impairment	Sensorimotor impairment will be measured by the Fugl-Meyer assessment.	Throughout the entire study (an average of 8 months)
Primary	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.	Throughout the entire study (an average of 8 months)
Primary	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.	Throughout the entire study (an average of 8 months)
Primary	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.	Throughout the entire study (an average of 8 months)
Primary	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.	Throughout the entire study (an average of 8 months)
Primary	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.	Throughout the entire study (an average of 8 months)
Primary	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.	Throughout the entire study (an average of 8 months)
Primary	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.	Throughout the entire study (an average of 8 months)
Primary	Strength of the upper-limbs	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)
Primary	Passive range of motion the upper-limbs	Passive range of motion of the upper-limbs will be measured using a goniometer.	Throughout the entire study (an average of 8 months)
Secondary	Body temperature	Body temperature will be evaluated using a tympanic thermometer.	Throughout the entire study (an average of 8 months)
Secondary	Blood oxygen saturation	Blood oxygen saturation will be evaluated using a pulse oximeter.	Throughout the entire study (an average of 8 months)
Secondary	Heart beat rate	Heart beat rate will be evaluated using a heart rate monitor.	Throughout the entire study (an average of 8 months)
Secondary	Blood pressure	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)