Adaptive Sports for Individuals With a Physical Disability : Effect Among Stroke Survivors (APSA-AVC)

L'activitié Physique Sportive organisée Pour Sujets en Situation de Handicap : Impact Chez Les Sujets Post-accident Vasculaire cérébrale, Sur Les Trois Domaines de la Classification Internationale du Fonctionnement, du Handicap et de la santé (CIF)

The objective of the study is to evaluate the effect of engaging in adaptive sports for individuals who have had a stroke. The study is cross-sectional, participants with stroke will be recruited and divided into two groups: the first group composed of individuals with stroke who regularly participate in adaptive sports; and the second of individuals with stroke who do not regularly participate in adaptive sports. The two groups will have to be similar in terms of demographic variables (age, gender, time since beginning of stroke). A series of parameters will be tested, on one occasion for each participant. The two groups will then be compared to one another.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Adaptive sports

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Louise Declerck, PT; Phone Number: +32476480314; Email: louise.declerck@uclouvain.be

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc
    • Contact: Stoquart, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population are individuals with a stroke diagnosis since a minimum of 6 months prior to the study. These individuals have to present persistent physical disability due to their stroke. The investigators will recruit individuals with stroke who participate in organised adaptive sports programs on a regular basis, as well as individuals who do not participate in any oranised adaptive sports programs.

Description

Inclusion Criteria:

• diagnosis of stroke since at least 6 months prior to recruitment in the study
• persistent physical disability due to the stroke
• adequate understanding of french

Exclusion Criteria:

• significant cognitive impairments
• contra-indication of any type to performing physical activity and physical exercise

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adaptive sports group; Individuals with stroke who regularly, and on a long-term basis, participate in adaptive sports	Other: Adaptive sports; Participation in community adaptive sports programs
Non adaptive sports group; Individuals with stroke who do not engage in adaptive sports

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional walking	Measured through a 6 minute-walk test where participants walk back and forth from one cone to another (placed 30 meters away), during 6 minutes. The distance walked in the 6 minutes is calculated.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical endurance	Measured through a sub-maximal effort test on cycle ergometer.	baseline
Motor impairment	Measured by the Fugl-Meyer Assessment. The score ranges from 0-226, where lower scores represent greater motor impairment.	baseline
Upper and lower limb strength	Measured using a manual dynamometer (microfet), in flexion, extension, adduction, abduction, internal rotation and external rotation of each limb.	baseline
Functional autonomy	Measured using the Functional Independence Measure. Total scores range from 8 to 126 points. A lower score corresponds to complete dependence/no autonomy.	baseline
Functional walking capacity	Measured by the timed up and go test.	baseline
Functional walking speed	Measured by the 10 meter walk test.	baseline
Locomotion ability	Measured by the Abiloco questionnaire. Score ranges from 0 to 13, where lower scores represent loss locomotion ability.	baseline
Balance	Measured by the Activities-specific balance confidence scale. Scores range from 0 to 160, where higher score mean better confidence in balance.	baseline
Physical activity level (subjective)	Measured by the Physical activity scale for individuals with physical disabilities. Scores range from 0 to 199.5 MET hour per day, where a greater score represents a greater level of physical activity.	baseline
Volume of physical activity performed daily	Measured by an accelerometer.	baseline, during one week
Fatigue	Measured by the fatigue severity scale. Scores range from 9 to 63 where a higher score represents greater fatigue severity.	baseline
Satisfaction with quality of life	Measured by the EUROHIS-QOL (European Health Interview Survey, Quality of Life) 8 item questionnaire. Scores range from 0 to 40, with a greater score representing a better quality of life.	baseline
Social participation	Measured by the Return to normal living index, a scale ranging from 0 to 100, with a greater score for greater social participation.	baseline
Intensity of physical activity performed daily	Measured by a heart rate monitor	baseline, during one week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic variables	Questionnaire asking participants to report age, gender, date of stroke, type of stroke as well as number of weekly sessions in any type of organised physical activity.	baseline
Medical and paramedical data	Questionnaire asking participants to report any medication taken at the time of study participation, number of weekly sessions of physiotherapy and number of weekly sessions of other therapy.	baseline

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2022/13AVR/164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No