StrokeAPSA-AVCNCT05443529
Adaptive Sports for Individuals With a Physical Disability : Effect Among Stroke Survivors
An observational study of Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Adaptive sports
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Oct 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- significant cognitive impairments
- contra-indication of any type to performing physical activity and physical exercise
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Stoquart, Prof
About this study
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)
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.
- Conditions
- Stroke
- Being tested
- Adaptive sports
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive sportsOther
Participation in community adaptive sports programs
| Study group | Role | What they receive |
|---|---|---|
| Adaptive sports group | Individuals with stroke who regularly, and on a long-term basis, participate in adaptive sports Receives: Other: Adaptive sports | |
| Non adaptive sports group | Individuals with stroke who do not engage in adaptive sports |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (14)
Physical endurance
Measured through a sub-maximal effort test on cycle ergometer.
Measured: baseline
Motor impairment
Measured by the Fugl-Meyer Assessment. The score ranges from 0-226, where lower scores represent greater motor impairment.
Measured: 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.
Measured: 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.
Measured: baseline
Functional walking capacity
Measured by the timed up and go test.
Measured: baseline
Functional walking speed
Measured by the 10 meter walk test.
Measured: baseline
Locomotion ability
Measured by the Abiloco questionnaire. Score ranges from 0 to 13, where lower scores represent loss locomotion ability.
Measured: baseline
Balance
Measured by the Activities-specific balance confidence scale. Scores range from 0 to 160, where higher score mean better confidence in balance.
Measured: 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.
Measured: baseline
Volume of physical activity performed daily
Measured by an accelerometer.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Intensity of physical activity performed daily
Measured by a heart rate monitor
Measured: baseline, during one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start18 Oct 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaëtan Stoquart, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443529
- Sponsor's protocol ID
- 2022/13AVR/164
- Acronym
- APSA-AVC
- Status last verified
- Nov 2023
- First submitted
- 23 Jun 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05443529
- Acronym / sponsor ID
- APSA-AVC / 2022/13AVR/164
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive sports group | – | Other: Adaptive sportsIndividuals with stroke who regularly, and on a long-term basis, participate in adaptive sports |
| Non adaptive sports group | – | –Individuals with stroke who do not engage in adaptive sports |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- significant cognitive impairments
- contra-indication of any type to performing physical activity and physical exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive sportsParticipation in community adaptive sports programs | Other | Adaptive sports group |
Primary outcome
Functional walking
Time frame: baseline
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.
14 secondary outcomes
Physical endurance
Time frame: baseline
Motor impairment
Time frame: baseline
Upper and lower limb strength
Time frame: baseline
Functional autonomy
Time frame: baseline
Functional walking capacity
Time frame: baseline
Functional walking speed
Time frame: baseline
Locomotion ability
Time frame: baseline
Balance
Time frame: baseline
Physical activity level (subjective)
Time frame: baseline
Volume of physical activity performed daily
Time frame: baseline, during one week
Fatigue
Time frame: baseline
Satisfaction with quality of life
Time frame: baseline
Social participation
Time frame: baseline
Intensity of physical activity performed daily
Time frame: baseline, during one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaëtan Stoquart, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louise Declerck, PT (+32476480314, louise.declerck@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional walking (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.