CClinicalTrials.gg
RecruitingNCT05443529APSA-AVCUpdated Nov 24, 2023

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

An observational study in Stroke, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-24.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Oct 2022; still recruiting 3 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 50 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • significant cognitive impairments
  • contra-indication of any type to performing physical activity and physical exercise
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adaptive sports group

    Individuals with stroke who regularly, and on a long-term basis, participate in adaptive sports

    Other: Adaptive sports

  • Non adaptive sports group

    Individuals with stroke who do not engage in adaptive sports

Interventions

  • OtherAdaptive sports

    Participation in community adaptive sports programs

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline

Secondary outcomes

  1. Physical endurance

    Measured through a sub-maximal effort test on cycle ergometer.

    Time frame: baseline

  2. Motor impairment

    Measured by the Fugl-Meyer Assessment. The score ranges from 0-226, where lower scores represent greater motor impairment.

    Time frame: baseline

  3. Upper and lower limb strength

    Measured using a manual dynamometer (microfet), in flexion, extension, adduction, abduction, internal rotation and external rotation of each limb.

    Time frame: baseline

  4. 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.

    Time frame: baseline

  5. Functional walking capacity

    Measured by the timed up and go test.

    Time frame: baseline

  6. Functional walking speed

    Measured by the 10 meter walk test.

    Time frame: baseline

  7. Locomotion ability

    Measured by the Abiloco questionnaire. Score ranges from 0 to 13, where lower scores represent loss locomotion ability.

    Time frame: baseline

  8. Balance

    Measured by the Activities-specific balance confidence scale. Scores range from 0 to 160, where higher score mean better confidence in balance.

    Time frame: baseline

  9. 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.

    Time frame: baseline

  10. Volume of physical activity performed daily

    Measured by an accelerometer.

    Time frame: baseline, during one week

  11. Fatigue

    Measured by the fatigue severity scale. Scores range from 9 to 63 where a higher score represents greater fatigue severity.

    Time frame: baseline

  12. 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.

    Time frame: baseline

  13. 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.

    Time frame: baseline

  14. Intensity of physical activity performed daily

    Measured by a heart rate monitor

    Time frame: baseline, during one week

Other outcomes

  1. 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.

    Time frame: baseline

  2. 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.

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
  • Cliniques Universitaires Saint-Luc
    Brussels, 1200, Belgium
    • Stoquart, Prof · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05443529
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Sponsor
First posted
Jul 5, 2022
Start date
Oct 18, 2022
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Nov 24, 2023

Study contacts

Louise Declerck, PT
Contact
louise.declerck@uclouvain.be
+32476480314
Gaëtan Stoquart, MD
Contact
gaetan.stoquart@saintluc.uclouvain.be
+3227641649
Gaëtan Stoquart, MD
principal investigator · Cliniques universitaires Saint-Luc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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