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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02550834
Other study ID # 44408
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 9, 2015
Last updated February 23, 2016
Start date August 2015
Est. completion date February 2016

Study information

Verified date February 2016
Source HES-SO Valais-Wallis
Contact n/a
Is FDA regulated No
Health authority Commission cantonale valaisanne d'éthique médicale, Switzwerland ':'
Study type Interventional

Clinical 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. Half of participants will receive 8 training-sessions during 4 weeks, while the other will receive usual care.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date February 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Wheelchair indoors curling training
8x 90 minutes of training and playing indoors curling in 4 weeks

Locations

Country Name City State
Switzerland Clinique romande de réadaptation CRR-SUVA Sion Valais
Switzerland Uniklink Balgrist Zurich

Sponsors (3)

Lead Sponsor Collaborator
HES-SO Valais-Wallis Clinique Romande de Réadaptation CRR-Suva, Uniklinik Balgrist, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 8 weeks Yes
Secondary Intrinsic Motivation Intrinsic Motivation Inventory (IMI) 8 weeks No
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