Adaptive Sports for Individuals With a Physical Disability : Effect Among Stroke Survivors

Stroke Clinical Trial

— APSA-AVC  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443529
• Other study ID #: 2022/13AVR/164
• Status: Recruiting
• Start date: October 18, 2022
• Est. completion date: December 2023

Study information

• Verified date: November 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Louise Declerck, PT
• Phone: +32476480314
• Email: louise.declerck[@]uclouvain.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Adaptive sports
Participation in community adaptive sports programs

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	Physical endurance	Measured through a sub-maximal effort test on cycle ergometer.	baseline
Secondary	Motor impairment	Measured by the Fugl-Meyer Assessment. The score ranges from 0-226, where lower scores represent greater motor impairment.	baseline
Secondary	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
Secondary	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
Secondary	Functional walking capacity	Measured by the timed up and go test.	baseline
Secondary	Functional walking speed	Measured by the 10 meter walk test.	baseline
Secondary	Locomotion ability	Measured by the Abiloco questionnaire. Score ranges from 0 to 13, where lower scores represent loss locomotion ability.	baseline
Secondary	Balance	Measured by the Activities-specific balance confidence scale. Scores range from 0 to 160, where higher score mean better confidence in balance.	baseline
Secondary	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
Secondary	Volume of physical activity performed daily	Measured by an accelerometer.	baseline, during one week
Secondary	Fatigue	Measured by the fatigue severity scale. Scores range from 9 to 63 where a higher score represents greater fatigue severity.	baseline
Secondary	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
Secondary	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
Secondary	Intensity of physical activity performed daily	Measured by a heart rate monitor	baseline, during one week