Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 6:25 PM
Study NCT ID:
NCT00438750
Status:
COMPLETED
Last Update Posted:
2012-06-08
First Post:
2007-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009788', 'term': 'Occupational Therapy'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dring@partners.org', 'phone': '617-724-3953', 'title': 'David Ring, MD, PhD', 'organization': 'Orthopaedic Hand and Upper Extremity Service, Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Independent Exercise Cohort', 'description': 'Subjects who learn their therapy exercises from the surgeon and practice them independently at home.', 'otherNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Occupational Therapy Cohort', 'description': 'Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.', 'otherNumAtRisk': 46, 'otherNumAffected': 2, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Extensor pollicis longus tendon rupture', 'notes': 'Subject declined tendon transfer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Loosening and prominence of a distal (periarticular) screw', 'notes': 'Subject underwent implant removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Range of Motion in Degrees of the Wrists', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Independent Exercise Cohort', 'description': 'Subjects who learn their therapy exercises from the surgeon and practice them independently at home.'}, {'id': 'OG001', 'title': 'Occupational Therapy Cohort', 'description': 'Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.'}], 'classes': [{'categories': [{'measurements': [{'value': '129', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '118', 'spread': '17.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Mean arc of wrist flexion and extension six months after surgery.\n\nNormal/expected range of motion for arc of wrist flexion and extension is approximately 160 degrees.', 'unitOfMeasure': 'Degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Independent Exercise Cohort', 'description': 'Subjects who learn their therapy exercises from the surgeon and practice them independently at home.'}, {'id': 'OG001', 'title': 'Occupational Therapy Cohort', 'description': 'Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '6.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.\n\nMean and standard deviations are identical for both arms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '10-point Ordinal Pain Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Independent Exercise Cohort', 'description': 'Subjects who learn their therapy exercises from the surgeon and practice them independently at home.'}, {'id': 'OG001', 'title': 'Occupational Therapy Cohort', 'description': 'Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pinch Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Independent Exercise Cohort', 'description': 'Subjects who learn their therapy exercises from the surgeon and practice them independently at home.'}, {'id': 'OG001', 'title': 'Occupational Therapy Cohort', 'description': 'Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '17', 'spread': '8.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Pinch strength measured with the B\\&L pinch gauge.\n\nB\\&L Engineering is the official name of the company (nowhere is there an expansion of this acronym).', 'unitOfMeasure': 'Pounds (lbs)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gartland and Werley Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Independent Exercise Cohort', 'description': 'Subjects who learn their therapy exercises from the surgeon and practice them independently at home.'}, {'id': 'OG001', 'title': 'Occupational Therapy Cohort', 'description': 'Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'An objective evaluation of wrist function with 0 to 2 as excellent, 3-8 as good, 9-20 as fair, and 21 and above as poor range of motion.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mayo Wrist Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Independent Exercise Cohort', 'description': 'Subjects who learn their therapy exercises from the surgeon and practice them independently at home.'}, {'id': 'OG001', 'title': 'Occupational Therapy Cohort', 'description': 'Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.4', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '79.0', 'spread': '9.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'A composite score based on pain intensity, range of motion, grip strength, and functional status. The scale is as follows: below 60 is poor, 60-80 is satisfactory, 80-90 is good, and 90-100 is excellent.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Grip Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Independent Exercise Cohort', 'description': 'Subjects who learn their therapy exercises from the surgeon and practice them independently at home.'}, {'id': 'OG001', 'title': 'Occupational Therapy Cohort', 'description': 'Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '51', 'spread': '17.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Measured with use of a grip meter as the average of three attempts.', 'unitOfMeasure': 'Pounds (lbs)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Independent Exercise Cohort', 'description': 'Subjects who learn their therapy exercises from the surgeon and practice them independently at home.'}, {'id': 'FG001', 'title': 'Occupational Therapy Cohort', 'description': 'Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Independent Exercise Cohort', 'description': 'Subjects who learn their therapy exercises from the surgeon and practice them independently at home.'}, {'id': 'BG001', 'title': 'Occupational Therapy Cohort', 'description': 'Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'spread': '15', 'groupId': 'BG000'}, {'value': '51', 'spread': '15', 'groupId': 'BG001'}, {'value': '50', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-01', 'studyFirstSubmitDate': '2007-02-20', 'resultsFirstSubmitDate': '2012-03-27', 'studyFirstSubmitQcDate': '2007-02-21', 'lastUpdatePostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-25', 'studyFirstPostDateStruct': {'date': '2007-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of Motion in Degrees of the Wrists', 'timeFrame': '6 months', 'description': 'Mean arc of wrist flexion and extension six months after surgery.\n\nNormal/expected range of motion for arc of wrist flexion and extension is approximately 160 degrees.'}], 'secondaryOutcomes': [{'measure': 'Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire', 'timeFrame': '6 months', 'description': 'The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.\n\nMean and standard deviations are identical for both arms.'}, {'measure': '10-point Ordinal Pain Scale', 'timeFrame': '6 months', 'description': 'A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever.'}, {'measure': 'Pinch Strength', 'timeFrame': '6 months', 'description': 'Pinch strength measured with the B\\&L pinch gauge.\n\nB\\&L Engineering is the official name of the company (nowhere is there an expansion of this acronym).'}, {'measure': 'Gartland and Werley Score', 'timeFrame': '6 months', 'description': 'An objective evaluation of wrist function with 0 to 2 as excellent, 3-8 as good, 9-20 as fair, and 21 and above as poor range of motion.'}, {'measure': 'Mayo Wrist Score', 'timeFrame': '6 months', 'description': 'A composite score based on pain intensity, range of motion, grip strength, and functional status. The scale is as follows: below 60 is poor, 60-80 is satisfactory, 80-90 is good, and 90-100 is excellent.'}, {'measure': 'Grip Strength', 'timeFrame': '6 months', 'description': 'Measured with use of a grip meter as the average of three attempts.'}]}, 'conditionsModule': {'keywords': ['distal radius fracture', 'rehabilitation', 'volar plate fixation', 'DASH questionnaire'], 'conditions': ['Distal Radius Fractures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare to ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.', 'detailedDescription': 'Operative treatment of distal radius fractures has become commonplace over the last three decades as our understanding of the relationship between the alignment of the distal radius and the function of the wrist and forearm has improved. Over the last 15 years there has been a trend towards more invasive, internal plate fixation of fractures of the distal radius. One argument in favor of internal fixation for these fractures is that it would be beneficial to allow early movement of the wrist articulation in an attempt to maximize final outcome. There is a difference in opinion among physicians on the importance of supervision of exercises in the recovery process. Some physicians advocate formal occupational therapy while other physicians believe that appropriate instructions for home exercises are just as good. A common belief is that the motivation of the patient plays an important part in recovery. In addition, Psychological and personality factors, such as pain anxiety, catastrophizing, and depression are strongly related to upper extremity specific health status and may also influence recovery. The goal of this study is to determine which protocol for exercises leads to better outcome in patients treated for distal radius with a volar plate. As a secondary goal and to generate hypotheses for later studies we would like to evaluate the influence of psychosocial factors on both objective (motion, grip strength) and subjective (DASH questionnaire) measures of functional recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or greater.\n* Isolated distal radial fracture.\n* Fracture treated with volar plates, stable fixation.\n* Initial treatment within 4 weeks of trauma.\n\nExclusion Criteria:\n\n* Complex fractures that require additional or different material than volar plates.'}, 'identificationModule': {'nctId': 'NCT00438750', 'briefTitle': 'Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Prospective Randomized Comparison of Occupational Therapy vs Home Exercises After Volar Plate Fixation of a Fracture of the Distal Radius', 'orgStudyIdInfo': {'id': '2006-P-001157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Independent Home Exercises', 'description': 'Subjects who learn their therapy exercises from the surgeon and practice them independently at home.', 'interventionNames': ['Other: Independent Excercises']}, {'type': 'EXPERIMENTAL', 'label': 'Formal Therapy', 'description': 'Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.', 'interventionNames': ['Other: Occupational Therapy']}], 'interventions': [{'name': 'Independent Excercises', 'type': 'OTHER', 'description': 'Subjects provided with wrist splint and instructions for independent exercises to perform at home on their own. Subjects were advised to perform exercises as often as possible, but at least three to four times a day for a minimum of thirty minutes. There was no formal strengthening program.', 'armGroupLabels': ['Independent Home Exercises']}, {'name': 'Occupational Therapy', 'type': 'OTHER', 'description': 'Subjects were prescribed formal occupational therapy with supervised exercises to regain digit, wrist, and forearm motion and to strengthen the hand. The content, frequency, and duration of the rehabilitation program were at the discretion of the treating hand therapist.', 'armGroupLabels': ['Formal Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'David Ring, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator; Director of Research, Hand Service', 'investigatorFullName': 'David C. Ring, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}