Effects of Power Wheelchair Soccer for Individuals Presenting With Physical Impairments

NCT06259643 | Recruiting

• 1 other identifier: FOOT FAUTEUIL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuromuscular Diseases; Cerebral Palsy

Outcome Measures

Primary Outcomes (13)

• 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)

• 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)

• 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)

• Sensorimotor impairment

  Sensorimotor impairment will be measured by the Fugl-Meyer assessment.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Throughout the entire study (an average of 8 months)

Secondary Outcomes (4)

• Body temperature

  Throughout the entire study (an average of 8 months)

• Blood oxygen saturation

  Throughout the entire study (an average of 8 months)

• Heart beat rate

  Throughout the entire study (an average of 8 months)

• Blood pressure

  Throughout the entire study (an average of 8 months)

Other Outcomes (2)

• Satisfaction with the power wheelchair soccer practices

  Throughout the entire study (an average of 8 months)

• Demographic variables

  Throughout the entire study (an average of 8 months)

Study Arms (1)

Power wheelchair soccer

EXPERIMENTAL

soccer game performed with a wheelchair

Other: Power wheelchair soccer

Interventions

Power wheelchair soccer OTHER

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.

Power wheelchair soccer

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Neuromusculoskeletal Lab

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases; Cerebral Palsy

Condition Hierarchy (Ancestors)

Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

Louise Declerck, PT

CONTACT

0476480314; louise.declerck@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 14, 2024
• Study Start: November 1, 2023
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)