Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-03 @ 7:11 AM
Study NCT ID:
NCT02550834
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2015-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wheelchair Indoors Curling With SCI patients_RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2015-09-09', 'studyFirstSubmitQcDate': '2015-09-14', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sitting balance', 'timeFrame': '8 weeks', 'description': 'Control capabilities of trunk movement (6-channel inertial sensor by 25 cycles per minute, back-and-forth trunk movements), Modified Functional Reach Test'}], 'secondaryOutcomes': [{'measure': 'Intrinsic Motivation', 'timeFrame': '8 weeks', 'description': 'Intrinsic Motivation Inventory (IMI)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Core stability', 'Indoors curling exercises', 'Motivation'], 'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nMaintaining 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Traumatic, non-traumatic or ischemic Spinal Cord Injury with complete or incomplete para- or tetraplegia\n* Complete spinal cord status (ASIA Score)\n* Sitting capabilities ≥ 4 hours\n* Capability to bench 20° forward in trunk flexion\n* Signed informed consent after being informed\n\nExclusion Criteria:\n\n* Progressives pathologies\n* Problem in vestibular system\n* Severely impaired vision\n* Tetraplegia without hand function\n* Acute pain\n* Contraindications on ethical grounds\n* Previously reduced capabilities of cooperation\n* Know or suspected non-compliance'}, 'identificationModule': {'nctId': 'NCT02550834', 'acronym': 'SCI-RCT', 'briefTitle': 'Wheelchair Indoors Curling With SCI patients_RCT', 'organization': {'class': 'OTHER', 'fullName': 'HES-SO Valais-Wallis'}, 'officialTitle': 'The Effects of Indoors Curling Exercise in Persons With Chronic Spinal Cord Injury on Control Capabilities of Trunk Movements: a Randomized-controlled Trial.', 'orgStudyIdInfo': {'id': '44408'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental : Curling group', 'interventionNames': ['Other: Wheelchair indoors curling training']}, {'type': 'NO_INTERVENTION', 'label': 'Control : Usual care group'}], 'interventions': [{'name': 'Wheelchair indoors curling training', 'type': 'OTHER', 'description': '8x 90 minutes of training and playing indoors curling in 4 weeks', 'armGroupLabels': ['Experimental : Curling group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Uniklink Balgrist', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '1951', 'city': 'Sion', 'state': 'Valais', 'country': 'Switzerland', 'facility': 'Clinique romande de réadaptation CRR-SUVA', 'geoPoint': {'lat': 46.22739, 'lon': 7.35559}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HES-SO Valais-Wallis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinique Romande de Readaptation', 'class': 'NETWORK'}, {'name': 'Uniklinik Balgrist, Zürich', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mittaz Hager Anne-Gabrielle', 'investigatorAffiliation': 'HES-SO Valais-Wallis'}}}}