Wheelchair Indoors Curling With SCI patients_RCT (SCI-RCT)
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Wheelchair indoors curling training
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Core stability, Indoors curling exercises, Motivation
Eligibility Criteria
Inclusion Criteria:
- Traumatic, non-traumatic or ischemic Spinal Cord Injury with complete or incomplete para- or tetraplegia
- Complete spinal cord status (ASIA Score)
- Sitting capabilities ≥ 4 hours
- Capability to bench 20° forward in trunk flexion
- Signed informed consent after being informed
Exclusion Criteria:
- Progressives pathologies
- Problem in vestibular system
- Severely impaired vision
- Tetraplegia without hand function
- Acute pain
- Contraindications on ethical grounds
- Previously reduced capabilities of cooperation
- Know or suspected non-compliance
Sites / Locations
- Clinique romande de réadaptation CRR-SUVA
- Uniklink Balgrist
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental : Curling group
Control : Usual care group
Arm Description
Outcomes
Primary Outcome Measures
Sitting balance
Control capabilities of trunk movement (6-channel inertial sensor by 25 cycles per minute, back-and-forth trunk movements), Modified Functional Reach Test
Secondary Outcome Measures
Intrinsic Motivation
Intrinsic Motivation Inventory (IMI)
Full Information
NCT ID
NCT02550834
First Posted
September 9, 2015
Last Updated
February 23, 2016
Sponsor
HES-SO Valais-Wallis
Collaborators
Clinique Romande de Readaptation, Uniklinik Balgrist, Zürich
1. Study Identification
Unique Protocol Identification Number
NCT02550834
Brief Title
Wheelchair Indoors Curling With SCI patients_RCT
Acronym
SCI-RCT
Official Title
The Effects of Indoors Curling Exercise in Persons With Chronic Spinal Cord Injury on Control Capabilities of Trunk Movements: a Randomized-controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HES-SO Valais-Wallis
Collaborators
Clinique Romande de Readaptation, Uniklinik Balgrist, Zürich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study investigates if, patients with diagnosed chronic spinal cord injury will benefit from an Indoor Curling Exercise program on their control capabilities of trunk movements and on their intrinsic motivation for physical activity. Half of participants will receive 8 training-sessions during 4 weeks, while the other will receive usual care.
Detailed Description
Spinal cord injury (SCI) is a catastrophic event that can be devastating and costly in human and social terms. These patients require multidisciplinary and interdisciplinary treatment. Physiotherapy is important factor in SCI rehabilitation.
The objectives of physiotherapists are manifold and include the development of the force of healthy muscles, the teaching of transfer techniques, the maintenance of joint motion and of the body map, and the reestablishment of sitting balance in order for the patients to regain their autonomy.
Maintaining postural stability when seated is a challenge for people with a SCI as their sensory and motor systems in their trunk, lower and upper extremities have been damaged to different degrees. To train this postural stability, physiotherapists include many interventions. Physical activities in sport therapy are some of them. In addition to usual physical activities (basketball, tennis, wheelchair running,…) the investigators propose to practice wheelchair Indoors Curling Exercise with wooden Curling Stones.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Core stability, Indoors curling exercises, Motivation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental : Curling group
Arm Type
Experimental
Arm Title
Control : Usual care group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Wheelchair indoors curling training
Intervention Description
8x 90 minutes of training and playing indoors curling in 4 weeks
Primary Outcome Measure Information:
Title
Sitting balance
Description
Control capabilities of trunk movement (6-channel inertial sensor by 25 cycles per minute, back-and-forth trunk movements), Modified Functional Reach Test
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Intrinsic Motivation
Description
Intrinsic Motivation Inventory (IMI)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Traumatic, non-traumatic or ischemic Spinal Cord Injury with complete or incomplete para- or tetraplegia
Complete spinal cord status (ASIA Score)
Sitting capabilities ≥ 4 hours
Capability to bench 20° forward in trunk flexion
Signed informed consent after being informed
Exclusion Criteria:
Progressives pathologies
Problem in vestibular system
Severely impaired vision
Tetraplegia without hand function
Acute pain
Contraindications on ethical grounds
Previously reduced capabilities of cooperation
Know or suspected non-compliance
Facility Information:
Facility Name
Clinique romande de réadaptation CRR-SUVA
City
Sion
State/Province
Valais
ZIP/Postal Code
1951
Country
Switzerland
Facility Name
Uniklink Balgrist
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
12. IPD Sharing Statement
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Wheelchair Indoors Curling With SCI patients_RCT
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