Spinal Cord InjuryPhase 1/2SCI-RCTNCT02550834
Wheelchair Indoors Curling With SCI patients_RCT
A Phase 1/2 study testing Wheelchair indoors curling training in people with Spinal Cord Injury, run by HES-SO Valais-Wallis at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Wheelchair indoors curling training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Aug 2015to Feb 2016
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Clinique romande de réadaptation CRR-SUVA
Sion, Valais, 1951
Uniklink Balgrist
Zurich, Canton of Zurich, 8008
About this study
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.
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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Wheelchair indoors curling training
- Keywords
- Core stability, Indoors curling exercises, Motivation
- 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.
Wheelchair indoors curling trainingOther
8x 90 minutes of training and playing indoors curling in 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental : Curling group | Experimental | Not described Receives: Other: Wheelchair indoors curling training |
| Control : Usual care group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (1)
Intrinsic Motivation
Intrinsic Motivation Inventory (IMI)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- HES-SO Valais-Wallis
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique Romande de Readaptation, Uniklinik Balgrist, Zürich
- Responsible party
- Principal investigator, Mittaz Hager Anne-Gabrielle, HES-SO Valais-Wallis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550834
- Sponsor's protocol ID
- 44408
- Acronym
- SCI-RCT
- Status last verified
- Feb 2016
- First submitted
- 9 Sep 2015
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02550834
- Acronym / sponsor ID
- SCI-RCT / 44408
- Conditions
- Spinal Cord Injury
- Keywords
- Core stability, Indoors curling exercises, Motivation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- HES-SO Valais-WallisUniversity, hospital or other
- Collaborators
- Clinique Romande de Readaptation, Uniklinik Balgrist, Zürich
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 16 Sep 2015 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental : Curling group | Experimental | Other: Wheelchair indoors curling training |
| Control : Usual care group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Progressives pathologies
- Problem in vestibular system
- Severely impaired vision
- Tetraplegia without hand function
- Acute pain
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 |
|---|---|---|
| Wheelchair indoors curling training8x 90 minutes of training and playing indoors curling in 4 weeks | Other | Experimental : Curling group |
Primary outcome
Sitting balance
Time frame: 8 weeks
Control capabilities of trunk movement (6-channel inertial sensor by 25 cycles per minute, back-and-forth trunk movements), Modified Functional Reach Test
1 secondary outcome
Intrinsic Motivation
Time frame: 8 weeks
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 24 Feb 2016.
Related trials for Spinal Cord Injury
Active, not recruitingPhase 1/2
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
Heterotopic Ossification (HO)
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Recruiting
Reticulospinal Control of Movements
Spinal Cord Injuries, Healthy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Wheelchair indoors curling training in people with Spinal Cord Injury, run by HES-SO Valais-Wallis at 2 sites in Switzerland.
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 5 inclusion and 8 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 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sitting balance (time frame: 8 weeks). 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 24 Feb 2016.