Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-02 @ 8:39 PM
Study NCT ID:
NCT02308618
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2014-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation Programs After Achilles Tendon Rupture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046353', 'term': 'Immobility Response, Tonic'}, {'id': 'D012422', 'term': 'Rupture, Spontaneous'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004434', 'term': 'Early Ambulation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2014-12-02', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Muscular electrical activation change', 'timeFrame': 'Muscular electrical activation was measured 3 times during the study: three, six and more than 12 months after surgical repair', 'description': 'Electrical activation was assessed by electromyography (EMG)'}, {'measure': 'Tendon mechanical and material properties change', 'timeFrame': 'Tendon mechanical and material properties were measured 3 times during the study: three, six and more than 12 months after surgical repair.', 'description': 'Tendon mechanical and material properties were assessed by Achilles tendon elongation (measured by ultrasound) during isometric plantar flexion ramp contraction as a function of ankle joint torque.'}, {'measure': 'Functional performance change', 'timeFrame': 'Functional performace was measured 3 times during the study: three, six and more than 12 months after surgical repair', 'description': 'Functional performance was assessed by functional tests (standing heel-rise, time up and go and jump tests) and AOFAS questionnaire.'}], 'primaryOutcomes': [{'measure': 'Torque change', 'timeFrame': 'Torque was measured 3 times during the study: three, six and more than 12 months after surgical repair.', 'description': 'Torque is an expression of the muscular strength and was assessed by dynamometry'}], 'secondaryOutcomes': [{'measure': 'Ankle range of motion change', 'timeFrame': 'Ankle range of motion was measured 5 times during the study: 15 days, 45 days, three, six and more than 12 months after surgical repair.', 'description': 'Ankle range of motion was assessed by goniometry during active and passive dorsiflexion and plantar flexion.'}, {'measure': 'Muscular architecture change', 'timeFrame': 'Muscle architecture was measured 4 times during the study: 45 days, three, six and more than 12 months after surgical repair.', 'description': 'Muscular architecture (muscle thickness, pennation angle and fascicle length) was assessed by ultrasonography'}, {'measure': 'Plantarflexor muscle volume change', 'timeFrame': 'Plantarflexor muscle volume was assessed 4 times during the study: 45 days, three, six and more than 12 months after surgical repair.', 'description': 'Plantarflexor muscle volume was estimated from calf muscle thickness and limb length using the equation proposed by Miyatani et al. 2004.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Achilles tendon rupture', 'Rehabilitation', 'Immobilization', 'Muscle architecture', 'Functionality', 'Neuromuscular parameters', 'Weight-Bearing'], 'conditions': ['Rupture of Achilles Tendon', 'Immobility Response, Tonic', 'Rupture, Spontaneous']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of early mobilization versus traditional immobilization rehabilitation programs after surgical Achilles tendon repair on the mechanical (torque-angle and torque-velocity relationships) and electrical (neuromuscular activation) properties of the plantar- and dorsiflexor muscles, gastrocnemius medialis morphology (muscle architecture), functional performance, and the mechanical and material properties (force-elongation and stress-strain relationships) of the injured and uninjured Achilles tendon.\n\nThe hypothesis is that the early mobilization could reduce the deleterious effects of the joint immobilization and improve the tendon healing.', 'detailedDescription': 'Participants were allocated into one of two intervention groups (traditional immobilization or early mobilization).\n\nTraditional immobilization group (45 days of plaster cast immobilization; after the immobilization period, subjects received instructions on how to perform a home-based exercise program)\n\nEarly mobilization (six weeks of physical therapy program; three times per week; one to two hours of exercises for regaining range of motion and muscular endurance)\n\nControl group (subjects had no history of lower limb injury, and were matched in age and anthropometric measurements to subjects that performed physical rehabilitation and to subjects that remained immobilized.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Achilles tendon rupture\n\nExclusion Criteria:\n\n* arterial insufficiency\n* diabetes\n* autoimmune disease\n* patients who used systemic antibiotics or steroids or showed any other clinical contraindication to perform maximum voluntary contractions on a dynamometer.'}, 'identificationModule': {'nctId': 'NCT02308618', 'briefTitle': 'Rehabilitation Programs After Achilles Tendon Rupture', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Rio Grande do Sul'}, 'officialTitle': 'Achilles Tendon Rupture: Comparative Study Between Two Rehabilitation Programs.', 'orgStudyIdInfo': {'id': 'UFRGS - 2007882'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Traditional Immobilization', 'description': '45 days of plaster cast immobilization After the immobilization period, subjects received instructions on how to perform a home-based exercise program', 'interventionNames': ['Other: Traditional Immobilization']}, {'type': 'EXPERIMENTAL', 'label': 'Early mobilization', 'description': 'Six weeks of physical therapy program', 'interventionNames': ['Other: Early Mobilization']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subjects had no history of lower limb injury, and were matched in age and anthropometric measurements to subjects that performed physical rehabilitation and to subjects that remained immobilized.'}], 'interventions': [{'name': 'Traditional Immobilization', 'type': 'OTHER', 'otherNames': ['Plaster cast immobilization'], 'description': 'After surgery subjects were immobilized in a plaster cast, with the ankle positioned in gravitational equinus; weight bearing was not allowed. Two weeks post-operatively, the cast was removed and the patient was immobilized with a new plaster cast, with the ankle in the same position. Four weeks post-operatively, the ankle was plastered in neutral position (i.e. with the sole of the foot perpendicular to the shank), and weight bearing was encouraged. Six weeks post-operatively, the plaster cast was removed\n\nThe home exercise program consisted of active exercises and stretches to improve ankle range of motion, and resistance and balance exercises', 'armGroupLabels': ['Traditional Immobilization']}, {'name': 'Early Mobilization', 'type': 'OTHER', 'otherNames': ['Accelerated rehabilitation'], 'description': 'The physical therapy started two weeks after the surgery and lasted six weeks, during which a removable brace was used. Therapy sessions, three times per week in the six-week period, included one to two hours of exercises for regaining range of motion and muscular endurance.', 'armGroupLabels': ['Early mobilization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90690-200', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Marco A Vaz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Rio Grande do Sul'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Rio Grande do Sul', 'class': 'OTHER'}, 'collaborators': [{'name': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.', 'class': 'OTHER_GOV'}, {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Marco Aurélio Vaz, PhD', 'investigatorAffiliation': 'Federal University of Rio Grande do Sul'}}}}