Spinal Cord InjuriesNCT04625309
Effect of Adaptive Sports After Acquired Physical Disability
A study testing Adaptive sports in people with Spinal Cord Injuries and Sports Physical Therapy, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study is a cross-sectional trial which aims to evaluate the effect of practicing a physical activity on different domains of the ICF among individuals with an acquired physical disability. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Sports Physical Therapy
- What is being tested?
- Adaptive sports
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Oct 2020to 7 Sep 2021
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed non-progressive spinal cord injury
- dependent on wheelchair for mobility
- more than 6 months since diagnosis of spinal injury
- able to understand and speak french
Who cannot join
- medical contra-indication to the testing
- cognitive deficiency which limits communication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptive Sports for Individuals With a Physical Disability: Impact on the ICF Domains
This study is a cross-sectional trial which aims to evaluate the effect of practicing a physical activity on different domains of the ICF among individuals with an acquired physical disability. Two different groups of individuals with a spinal cord injury will be enrolled: one composed of subjects who manage to reach the WHO's recommendations regarding physical activity, and the other of subjects who do not.
Read the detailed description
The present study will recruit participants based on a set of defined eligibility criteria, in adaptive sports clubs teams and in groups or associations of individuals with an acquired, and permanent, physical disability. Based on the presence or absence of a regular physical activity practice undertaken by the subjects who give their consent to participate in the study, they will be divided into two groups: one where individuals regularly practice a physical activity, and one where they do not.
A set of defined outcome measures (detailed in the "Outcome Measures"section) will be assessed in both groups.
The outcomes measures will be analysed statistically, using SPSS software. Depending on the nature of the variables (qualitative or quantitative), different tests will be performed. Normality will also be verified and will determine which statistical analysis will be carried out.
- Conditions
- Spinal Cord Injuries, Sports Physical Therapy
- Being tested
- Adaptive sports
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive sportsOther
This will be the number of hours per week the subjects actively partake in adaptive sports teams.
| Study group | Role | What they receive |
|---|---|---|
| Sport | Experimental | This group will be made up of subjects with a spinal cord injury that are actively participating in adaptive sports teams. Receives: Other: Adaptive sports |
| No sport | No intervention | This group will be made up of subjects with a spinal cord injury that are not actively participating in any sports team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain experienced during mobility
This variable will be measured through a Likert scale out of 5, where greater values show more pain during mobility. Subjects will be asked to rate presence, frequency and intensity of pain felt in the upper-limb when wheeling in their daily environments.
Measured: Throughout the study, an average of 4 months
Fatigue Severity
This variable will be measured using a validated questionnaire, "Fatigue Severity scale". The minimum score is 9, and the maximum is 63. The higher the score, the greater the fatigue severity (= worse outcome for the participant).
Measured: Throughout the study, an average of 4 months
Independence in mobility of daily living
This variable will be measured using the validated "Spinal Cord Independence Measure -mobility". Minimum score is 0 while maximum score is 40. The higher the score, the better the independence of the participant (=better outcome).
Measured: Throughout the study, an average of 4 months
Physical activity level
Measured by a validated questionnaire, "Physical Activity Scale for Individuals with a Physical Disability".
Measured: Through study completion, an average of 4 months
Social participation
This variable will be measured through the validated "Reintegration to Normal Living" index. Minimum score is 0, maximum score is 100. The higher the score, the better the outcome.
Measured: Throughout the study, an average of 4 months
Quality of Life: WHOQOL-BREF
This variable will be measured through the World Health Organization's 8th version questionnaire, the WHOQOL-BREF. Every one of the 4 domain can obtain a score ranging from 0 (minimum) to 100 (maximum). The higher the score, the greater the quality of life.
Measured: Throughout the study, an average of 4 months
patient's medical history
We will ask the subjects to report how many times they were hospitalised in the last six months and how many times they experienced a serious health-complication. We will also ask them how many times per week they receive physiotherapy.
Measured: Throughout the study, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start7 Oct 2020
- Primary completion7 Jul 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise Declerck, PT, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625309
- Sponsor's protocol ID
- SPORT DISABILITY
- Status last verified
- Sep 2021
- First submitted
- 20 Feb 2020
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Sports for Individuals With a Physical Disability: Impact on the ICF Domains
- ClinicalTrials.gov ID
- NCT04625309
- Acronym / sponsor ID
- SPORT DISABILITY
- Conditions
- Spinal Cord Injuries, Sports Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 12 Nov 2020 (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.
This study is a cross-sectional trial which aims to evaluate the effect of practicing a physical activity on different domains of the ICF among individuals with an acquired physical disability. Two different groups of individuals with a spinal cord injury will be enrolled: one composed of subjects who manage to reach the WHO's recommendations regarding physical activity, and the other of subjects who do not.
Detailed description
The present study will recruit participants based on a set of defined eligibility criteria, in adaptive sports clubs teams and in groups or associations of individuals with an acquired, and permanent, physical disability. Based on the presence or absence of a regular physical activity practice undertaken by the subjects who give their consent to participate in the study, they will be divided into two groups: one where individuals regularly practice a physical activity, and one where they do not.
A set of defined outcome measures (detailed in the "Outcome Measures"section) will be assessed in both groups.
The outcomes measures will be analysed statistically, using SPSS software. Depending on the nature of the variables (qualitative or quantitative), different tests will be performed. Normality will also be verified and will determine which statistical analysis will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sport | Experimental | Other: Adaptive sportsThis group will be made up of subjects with a spinal cord injury that are actively participating in adaptive sports teams. |
| No sport | No intervention | –This group will be made up of subjects with a spinal cord injury that are not actively participating in any sports team. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed non-progressive spinal cord injury
- dependent on wheelchair for mobility
- more than 6 months since diagnosis of spinal injury
- able to understand and speak french
Key exclusion criteria (2 listed)
- medical contra-indication to the testing
- cognitive deficiency which limits communication
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 sportsThis will be the number of hours per week the subjects actively partake in adaptive sports teams. | Other | Sport |
Primary outcome
Pain experienced during mobility
Time frame: Throughout the study, an average of 4 months
This variable will be measured through a Likert scale out of 5, where greater values show more pain during mobility. Subjects will be asked to rate presence, frequency and intensity of pain felt in the upper-limb when wheeling in their daily environments.
Fatigue Severity
Time frame: Throughout the study, an average of 4 months
This variable will be measured using a validated questionnaire, "Fatigue Severity scale". The minimum score is 9, and the maximum is 63. The higher the score, the greater the fatigue severity (= worse outcome for the participant).
Independence in mobility of daily living
Time frame: Throughout the study, an average of 4 months
This variable will be measured using the validated "Spinal Cord Independence Measure -mobility". Minimum score is 0 while maximum score is 40. The higher the score, the better the independence of the participant (=better outcome).
Physical activity level
Time frame: Through study completion, an average of 4 months
Measured by a validated questionnaire, "Physical Activity Scale for Individuals with a Physical Disability".
Social participation
Time frame: Throughout the study, an average of 4 months
This variable will be measured through the validated "Reintegration to Normal Living" index. Minimum score is 0, maximum score is 100. The higher the score, the better the outcome.
Quality of Life: WHOQOL-BREF
Time frame: Throughout the study, an average of 4 months
This variable will be measured through the World Health Organization's 8th version questionnaire, the WHOQOL-BREF. Every one of the 4 domain can obtain a score ranging from 0 (minimum) to 100 (maximum). The higher the score, the greater the quality of life.
patient's medical history
Time frame: Throughout the study, an average of 4 months
We will ask the subjects to report how many times they were hospitalised in the last six months and how many times they experienced a serious health-complication. We will also ask them how many times per week they receive physiotherapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Louise Declerck, PT principal investigator
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?
A study testing Adaptive sports in people with Spinal Cord Injuries and Sports Physical Therapy, run by 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 4 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: finished, as of the sponsor's last update on 4 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain experienced during mobility (time frame: Throughout the study, an average of 4 months). The study lists 7 primary outcomes in all. 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 4 Oct 2021.