NCT04625309

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 7, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2021

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

February 20, 2020

Last Update Submit

September 27, 2021

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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.

    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).

    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).

    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".

    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.

    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.

    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.

    Throughout the study, an average of 4 months

Study Arms (2)

Sport

EXPERIMENTAL

This group will be made up of subjects with a spinal cord injury that are actively participating in adaptive sports teams.

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.

Interventions

This will be the number of hours per week the subjects actively partake in adaptive sports teams.

Sport

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • medical contra-indication to the testing
  • cognitive deficiency which limits communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université catholique de Louvain

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Louise Declerck, PT

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

November 12, 2020

Study Start

October 7, 2020

Primary Completion

July 7, 2021

Study Completion

September 7, 2021

Last Updated

October 4, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations