Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 5:35 PM
Study NCT ID:
NCT03278834
Status:
COMPLETED
Last Update Posted:
2017-09-12
First Post:
2017-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NMES and Pelvic Fracture Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Treatment and intervention group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2014-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-08', 'studyFirstSubmitDate': '2017-07-13', 'studyFirstSubmitQcDate': '2017-09-08', 'lastUpdatePostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Strength', 'timeFrame': '12 weeks post operation', 'description': 'Peak Torque muscle strength'}], 'secondaryOutcomes': [{'measure': 'Feasibility questionnaire', 'timeFrame': '12 weeks post operation', 'description': 'questionnaire of 10 questions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trauma', 'Rehabilitation']}, 'descriptionModule': {'briefSummary': 'Objectives: The acute care of pelvic fractures has improved recently however there are no formal guidelines for rehabilitation of these types of fractures. Patients have long periods of non-weight bearing causing muscle wastage. Neuromuscular electrical stimulation (NMES) has proven to minimise muscle loss. However, this has not previously been investigated within this patient population.\n\nDesign: Double blind, randomised, feasibility study.\n\nSetting: NHS trust hospital setting.\n\nParticipants: Nine patients with surgically fixed pelvic fractures were randomly allocated at six weeks post fracture.\n\nInterventions: The intervention group completed six weeks of NMES. The placebo group used transcutaneous electrical nerve stimulation (TENS).\n\nMain outcome measures: Peak torque (Nm) was calculated in the operated limb at 12 weeks using the non-operated limb as a baseline. Compliance and intensity levels were recorded. Feasibility of NMES was evaluated using a feasibility questionnaire. Pain was measured at six and 12 weeks using a visual analogue scale (VAS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria were any patient with a pelvic fracture that was surgically fixed with no associated injuries and able to give written informed consent.\n* Pelvic fractures including acetabular and pelvic ring fracture that were fixed using open reduction internal fixation (ORIF) were considered.\n\nExclusion Criteria:\n\n* Exclusion criteria were patients who could not comply with the NMES or who had previous mental health diagnosis.\n* Patients who may be pregnant, have severe kidney injury or have a pacemaker were excluded.'}, 'identificationModule': {'nctId': 'NCT03278834', 'briefTitle': 'NMES and Pelvic Fracture Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Barts & The London NHS Trust'}, 'officialTitle': 'The Use of Neuromuscular Electrical Stimulation With Pelvic Fracture Rehabilitation: A Randomised, Double Blind, Pilot Study', 'orgStudyIdInfo': {'id': 'NMES Pilot Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Neuromuscular muscle stimulation machine - Muscle stimulation machine to be used on glutes and abductors on disuse atrophy setting.\n\nTwice per day for 45 minutes.\n\nExercise - Home exercises programme once per day with 10 exercises.', 'interventionNames': ['Device: Neuromuscular muscle stimulation machine- Strength Setting']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Neuromuscular muscle stimulation- Muscle stimulation machine to be used on glutes and abductors on TENS setting. Twice per day for 45 minutes.\n\nExercise - Home exercises programme once per day with 10 exercises.', 'interventionNames': ['Device: Neuromuscular muscle stimulation machine - TENS Setting']}], 'interventions': [{'name': 'Neuromuscular muscle stimulation machine- Strength Setting', 'type': 'DEVICE', 'description': 'Muscle stimulation to strength skeletal muscle', 'armGroupLabels': ['Intervention Group']}, {'name': 'Neuromuscular muscle stimulation machine - TENS Setting', 'type': 'DEVICE', 'description': 'Muscle stimulation to mimic the intervention but without the strength gains.', 'armGroupLabels': ['Placebo Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}