NCT05443529

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 18, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

June 23, 2022

Last Update Submit

November 22, 2023

Conditions

Outcome Measures

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.

    baseline

Secondary Outcomes (14)

  • Physical endurance

    baseline

  • Motor impairment

    baseline

  • Upper and lower limb strength

    baseline

  • Functional autonomy

    baseline

  • Functional walking capacity

    baseline

  • +9 more secondary outcomes

Other Outcomes (2)

  • Demographic variables

    baseline

  • Medical and paramedical data

    baseline

Study Arms (2)

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

Participation in community adaptive sports programs

Adaptive sports group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gaëtan Stoquart, MD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2022

First Posted

July 5, 2022

Study Start

October 18, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations