Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT06152133
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2023-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telerehabilitation, Core Stability Exercises and Hereditary Ataxia (TRCore-ataxia)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013132', 'term': 'Spinocerebellar Degenerations'}, {'id': 'D002524', 'term': 'Cerebellar Ataxia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001259', 'term': 'Ataxia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Pilot'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2023-11-21', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of dynamic sitting balance and trunk coordination', 'timeFrame': 'T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks', 'description': 'panish-version of Trunk Impairment Scale 2.0. Each item will be performed three times and the highest score counts. Otherwise, no practice session allowed. The patient can be corrected between attempts. The tests are verbally explained to the patient and can be demonstrated if needed. There are two subscales: dynamic sitting balance and coordination. The first have 10 items and second 6. The highest possible total score is consequently 16 points, which indicates a good dynamic sitting balance and correct trunk control and sitting coordination. If the patient cannot maintain a sitting position for 10 seconds without back and arm support, with hands on thighs, feet in contact with the ground and knees bent at 90° (starting position), the total score for the scale is 0 points.'}, {'measure': 'Static sitting balance and Standing balance', 'timeFrame': 'T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks', 'description': 'Static sitting balance will be recorded with the sitting section of SARA, standing balance will be recorded with the standing section of SARA as well, as well as walking.'}, {'measure': 'Walking Speed', 'timeFrame': 'T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks', 'description': 'The walking speed will be determined with the 4 meter walking test.'}], 'secondaryOutcomes': [{'measure': 'ADLs', 'timeFrame': 'T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks', 'description': 'ADLs will be assessed with the Activities-specific Balance Confidence (ABC)'}, {'measure': 'Lower extremity strength', 'timeFrame': 'T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks', 'description': 'Lower extremity strength will be assessed with the 30 s Sit-to-stand test.'}, {'measure': 'Adherence to treatment', 'timeFrame': 'T1: 7 weeks and T0: follow up 7 weeks', 'description': 'Adherence to treatment will be asses with the Exercise Adherence Rating Scale (EARS) (Newman-Beinart 2017).'}, {'measure': 'Risk of falls', 'timeFrame': 'T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks', 'description': 'The risk of falls with the Timed Up and GO scale'}, {'measure': 'Severity of ataxia', 'timeFrame': 'T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks', 'description': 'The severity of ataxia will be evaluated with the SARA scale'}, {'measure': 'Treatment compliance', 'timeFrame': 'T1: 7 weeks and T0: follow up 7 weeks', 'description': 'treatment compliance measured as the rate of sessions performed/prescribed (Capecci 2023), we will obtain the % compliance for each participant with the calculation Total number of minutes performed by the patient / Total number of minutes that should have been done (1400 minutes) x 100. Or with the calculation Total number of exercises per session performed by the patient / Total number of exercises that should have been done (23 per session) x 100'}, {'measure': 'Program satisfaction', 'timeFrame': 'T1: 7 weeks', 'description': 'A questionnaire will be administered to participants to evaluate both their experience and satisfaction with the program, as well as its adverse effects.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinocerebellar Degenerations', 'Telerehabilitation', 'Exercise'], 'conditions': ['Hereditary Ataxia', 'Spinocerebellar Degenerations', 'Cerebellar Ataxia']}, 'descriptionModule': {'briefSummary': 'Hereditary ataxias (HA) are a heterogeneous group of degenerative diseases of the cerebellum, brain stem and spinal cord. People who suffer from AH, among other symptoms, present deficiencies in the stability of the trunk, which leads to an alteration in postural control, with a strongly influential factor in the loss of balance and gait disorders. Improving the functionality of these physical aspects can help reduce the rate of falls, increase autonomy and quality of life for people with HA.\n\nEvidence suggests that rehabilitation strategies based on core stability exercises (CSE) are effective in improving balance and postural control in several neurological diseases, such as stroke. However, there is little evidence with people with HA. In a previous study carried out by researchers of this project, in which an EEC exercise program was piloted at home, low adherence to treatment was perceived due to the little follow-up that was given to the participants. Therefore, including telerehabilitation in these programs would increase follow-up and could influence adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Suffer from degenerative HA at any stage of the disease (Spinocerebellar ataxia, Friedreich's ataxia, sporadic idiopathic cerebellar ataxia and neurodegenerative diseases where ataxia is the dominant symptom).\n* Adults over 18 years of age.\n* Be able to use a computer or mobile phone (It will be evaluated using the DILE scale)\n* Have an internet connection.\n\nExclusion Criteria:\n\n* Suffer from other neurological diseases and inability to follow simple instructions. -\n* Suffering from a musculoskeletal injury that prevents you from performing the exercises.\n* Being unable to maintain standing for more than 10 seconds without support (assessed with item 2 on the SARA scale)."}, 'identificationModule': {'nctId': 'NCT06152133', 'acronym': 'TRCore-ataxia', 'briefTitle': 'Telerehabilitation, Core Stability Exercises and Hereditary Ataxia (TRCore-ataxia)', 'organization': {'class': 'OTHER', 'fullName': 'Universitat de Lleida'}, 'officialTitle': 'Effects of a Telerehabilitation Program of Central Stability Exercises to Improve Balance and Gait in Hereditary Ataxia. A Randomized Controlled Pilot Study.', 'orgStudyIdInfo': {'id': '01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation Core stability exercises group', 'interventionNames': ['Other: Therapeutic core stability exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Core stability exercises group', 'interventionNames': ['Other: Therapeutic core stability exercises']}], 'interventions': [{'name': 'Therapeutic core stability exercises', 'type': 'OTHER', 'otherNames': ['trunk exercises'], 'description': "exercises focused on trunk muscle strengthening, proprioception, selective movements of the trunk and pelvis muscle, and coordination, and will be carried out in supine, sitting on a stable surface and sitting on an unstable surface (ball). The exercise involves changes in the position of the body with or without resistance, aiming to improve strength, endurance, proprioception and coordination. Training is determined by the patient's ability to undertake easy exercises and progress to more challenging exercises.", 'armGroupLabels': ['Core stability exercises group', 'Telerehabilitation Core stability exercises group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25198', 'city': 'Lleida', 'state': 'Lleida', 'country': 'Spain', 'facility': 'University of Lleida', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat de Lleida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitat Internacional de Catalunya', 'class': 'OTHER'}, {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, {'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maria Masbernat-Almenara', 'investigatorAffiliation': 'Universitat de Lleida'}}}}