Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:33 PM
Study NCT ID:
NCT05537493
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2022-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tele-rehabilitation in Patients Operated for Distal Radius Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000069350', 'term': 'Telerehabilitation'}], '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'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Evaluator is blind to study groups'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Romdomised controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2022-09-09', 'studyFirstSubmitQcDate': '2022-09-09', 'lastUpdatePostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wrist joint range of motion', 'timeFrame': '0 day', 'description': 'Wrist joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.'}, {'measure': 'Wrist joint range of motion', 'timeFrame': '6 th week', 'description': 'Wrist joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.'}, {'measure': 'Wrist joint range of motion', 'timeFrame': '12 th week', 'description': 'Wrist joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.Likert scale. Patients are asked to indicate the level of pain, with 0 points as no pain, 5 points as moderate pain, and 10 points as unbearable pain. Increased scores indicate higher pain level.'}, {'measure': 'Environmental Measurement', 'timeFrame': '0 day', 'description': 'Environmental Measurement; Both hands and wrists of the patient will be measured with the figure of eight method with the help of a tape measure. The cm difference between both upper extremities will be recorded.'}, {'measure': 'Environmental Measurement', 'timeFrame': '6 th week', 'description': 'Environmental Measurement; Both hands and wrists of the patient will be measured with the figure of eight method with the help of a tape measure. The cm difference between both upper extremities will be recorded.'}, {'measure': 'Environmental Measurement', 'timeFrame': '12th week', 'description': 'Environmental Measurement; Both hands and wrists of the patient will be measured with the figure of eight method with the help of a tape measure. The cm difference between both upper extremities will be recorded.'}, {'measure': 'Quick-DASH', 'timeFrame': '0 day', 'description': 'The short version of the Arm, Shoulder and Hand Questionnaire (Quick-DASH) Disability will be used to evaluate the functional status of patients. Quick-DASH is a self-report questionnaire designed to measure physical function and symptoms in people with upper extremity musculoskeletal conditions. Turkish validity reliability was done'}, {'measure': 'Quick-DASH', 'timeFrame': '6th week', 'description': 'The short version of the Arm, Shoulder and Hand Questionnaire (Quick-DASH) Disability will be used to evaluate the functional status of patients. Quick-DASH is a self-report questionnaire designed to measure physical function and symptoms in people with upper extremity musculoskeletal conditions. Turkish validity reliability was done'}, {'measure': 'Quick-DASH', 'timeFrame': '12th week', 'description': 'The short version of the Arm, Shoulder and Hand Questionnaire (Quick-DASH) Disability will be used to evaluate the functional status of patients. Quick-DASH is a self-report questionnaire designed to measure physical function and symptoms in people with upper extremity musculoskeletal conditions. Turkish validity reliability was done'}, {'measure': 'Coarse Grip Strength', 'timeFrame': '0 day', 'description': 'Coarse Grip Strength: Coarse grip; It is caused by the combined activities of the intrinsic and extrinsic muscles of the hand. In our study, Jamar dynamometer was used for the evaluation of rough grip strength. The digital handheld dynamometer can measure in pounds and kg.'}, {'measure': 'Coarse Grip Strength', 'timeFrame': '6th week', 'description': 'Coarse Grip Strength: Coarse grip; It is caused by the combined activities of the intrinsic and extrinsic muscles of the hand. In our study, Jamar dynamometer was used for the evaluation of rough grip strength. The digital handheld dynamometer can measure in pounds and kg.'}, {'measure': 'Coarse Grip Strength', 'timeFrame': '12th week', 'description': 'Coarse Grip Strength: Coarse grip; It is caused by the combined activities of the intrinsic and extrinsic muscles of the hand. In our study, Jamar dynamometer was used for the evaluation of rough grip strength. The digital handheld dynamometer can measure in pounds and kg.'}, {'measure': 'Patient-Rated Wrist Evaluation (PRWE) questionnaire', 'timeFrame': '0 day', 'description': "Patient-Rated Wrist Evaluation (PRWE) questionnaire: PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. PRWE consists of 2 subscales that assess patients' wrist pain levels and disability. The PAIN subscale (0 = no pain, 10 = worst ever) and the FUNCTION subscale (0 = no difficulty, 10 = unable). Turkish validity and reliability was established."}, {'measure': 'Patient-Rated Wrist Evaluation (PRWE) questionnaire', 'timeFrame': '6th day', 'description': "Patient-Rated Wrist Evaluation (PRWE) questionnaire: PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. PRWE consists of 2 subscales that assess patients' wrist pain levels and disability. The PAIN subscale (0 = no pain, 10 = worst ever) and the FUNCTION subscale (0 = no difficulty, 10 = unable). Turkish validity and reliability was established."}, {'measure': 'Patient-Rated Wrist Evaluation (PRWE) questionnaire', 'timeFrame': '12th week', 'description': "Patient-Rated Wrist Evaluation (PRWE) questionnaire: PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. PRWE consists of 2 subscales that assess patients' wrist pain levels and disability. The PAIN subscale (0 = no pain, 10 = worst ever) and the FUNCTION subscale (0 = no difficulty, 10 = unable). Turkish validity and reliability was established."}, {'measure': 'pinch grip strength.', 'timeFrame': '0 day', 'description': "Pinchmeter device will be used to measure the pinch grip strength. The pinchmeter will be placed between the tip of the participant's thumb and the tip of the index finger to measure in the standard position recommended by the American Association of Hand Therapists (AETD)."}, {'measure': 'pinch grip strength.', 'timeFrame': '6 th week', 'description': "Pinchmeter device will be used to measure the pinch grip strength. The pinchmeter will be placed between the tip of the participant's thumb and the tip of the index finger to measure in the standard position recommended by the American Association of Hand Therapists (AETD)."}, {'measure': 'pinch grip strength.', 'timeFrame': '12th week', 'description': "Pinchmeter device will be used to measure the pinch grip strength. The pinchmeter will be placed between the tip of the participant's thumb and the tip of the index finger to measure in the standard position recommended by the American Association of Hand Therapists (AETD)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['telerehabilitation', 'distal radius fracture', 'functionality'], 'conditions': ['Distal Radius Fracture']}, 'referencesModule': {'references': [{'pmid': '26940798', 'type': 'BACKGROUND', 'citation': 'Bini SA, Mahajan J. Clinical outcomes of remote asynchronous telerehabilitation are equivalent to traditional therapy following total knee arthroplasty: A randomized control study. J Telemed Telecare. 2017 Feb;23(2):239-247. doi: 10.1177/1357633X16634518. Epub 2016 Jul 9.'}, {'pmid': '32197766', 'type': 'BACKGROUND', 'citation': 'Kane LT, Thakar O, Jamgochian G, Lazarus MD, Abboud JA, Namdari S, Horneff JG. The role of telehealth as a platform for postoperative visits following rotator cuff repair: a prospective, randomized controlled trial. J Shoulder Elbow Surg. 2020 Apr;29(4):775-783. doi: 10.1016/j.jse.2019.12.004.'}, {'pmid': '28449618', 'type': 'BACKGROUND', 'citation': 'Pastora-Bernal JM, Martin-Valero R, Baron-Lopez FJ, Moyano NG, Estebanez-Perez MJ. Telerehabilitation after arthroscopic subacromial decompression is effective and not inferior to standard practice: Preliminary results. J Telemed Telecare. 2018 Jul;24(6):428-433. doi: 10.1177/1357633X17706583. Epub 2017 Apr 27.'}]}, 'descriptionModule': {'briefSummary': "It was designed as a randomized controlled prospective. After 2 weeks of splint follow-up, the splints of the patients who were operated due to distal radius fracture and volar plate were applied will be removed and included in the physical therapy program. The measurements and scores of the patients at the time of removal of the splint will be recorded. Patients' non-injured contralateral extremity data will also be recorded. The dominant party will be registered. Preoperative fracture classification of the patients, reduction parameters after surgery, waiting time for post-fracture surgery, pre-fracture chronic diseases, cognitive disorders, psychiatric disease histories, whether the patients lived alone at home or not will be recorded. Patients will be randomized with the help of a free computer aided numerator. The patients will be divided into two groups and conventional face-to-face rehabilitation will be applied to one group, and the previously planned tele-rehabilitation program will be applied to the other group.", 'detailedDescription': "It was designed as a randomized controlled prospective. After 2 weeks of splint follow-up, the splints of the patients who were operated due to distal radius fracture and volar plate were applied will be removed and included in the physical therapy program. The measurements and scores of the patients at the time of removal of the splint will be recorded. Patients' non-injured contralateral extremity data will also be recorded. The dominant party will be registered. Preoperative fracture classification of the patients, reduction parameters after surgery, waiting time for post-fracture surgery, pre-fracture chronic diseases, cognitive disorders, psychiatric disease histories, whether the patients lived alone at home or not will be recorded. Patients will be randomized with the help of a free computer aided numerator. The patients will be divided into two groups and conventional face-to-face rehabilitation will be applied to one group, and the previously planned tele-rehabilitation program will be applied to the other group. Videos of the exercises they will do via whatsapp will be sent to the telerehabilitation group. Again, in telerehabilitation, whatapp application will be made in the form of videoconference. Rehabilitation program will be applied to the patients 4 times a week for 6 weeks. Rehabilitation will be applied to the groups by the same person. At the end of the rehabilitation program, the first measurements of the patients will be taken. The third measurement of the patients will be taken at the 3rd month after the surgery. Among the parameters to be checked, grip strength, wrist range of motion, Shortened Disabilities of the Arm, Shoulder, and Hand (QuickDASH) and Patient-Rated Wrist Evaluation (PRWE) questionnaire, VAS scale will be used. Solid side values will be recorded. Tele-rehabilitation satisfaction survey will be applied in the 3rd month controls of the patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Application of volar plate for distal radius fracture\n* Patients not having undergone any surgery on that extremity before, not having an extremity defect that prevents rehabilitation\n* Patients with normal pre-fracture cognitive functions\n* Patients without major postoperative complications\n\nExclusion Criteria:\n\n* Polytrauma\n* Previous extremity-related surgery\n* Injury in more than one anatomical region in the relevant extremity\n* Patients living alone at home\n* Malignancy, presence of known rheumatological disease, pregnancy\n* Patients receiving any treatment other than the planned treatment'}, 'identificationModule': {'nctId': 'NCT05537493', 'briefTitle': 'Tele-rehabilitation in Patients Operated for Distal Radius Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Ahi Evran University Education and Research Hospital'}, 'officialTitle': 'Efficiency of Telerehabilitation in Patients Operated With the Diagnosis of Distal Radius Fracture', 'orgStudyIdInfo': {'id': 'KAEK_2022-09/96'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation', 'description': 'Videos of the exercises they will do via whatsapp will be sent to the telerehabilitation group. Again, in telerehabilitation, whatapp application will be made in the form of videoconference. Rehabilitation program will be applied to the patients 4 times a week for 6 weeks.', 'interventionNames': ['Other: Telerehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Face to face', 'description': 'A rehabilitation program will be applied to the Face to Face rehabilitation group by a physiotherapist in the hospital for a total of 30 sessions per week for 6 weeks.', 'interventionNames': ['Other: Face to face']}], 'interventions': [{'name': 'Telerehabilitation', 'type': 'OTHER', 'description': 'It will be followed by exercising on whatsapp', 'armGroupLabels': ['Telerehabilitation']}, {'name': 'Face to face', 'type': 'OTHER', 'description': 'It will be followed by face to face', 'armGroupLabels': ['Face to face']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40100', 'city': 'Kirşehir', 'state': 'City Centre', 'country': 'Turkey (Türkiye)', 'facility': 'Ahi Evran University'}], 'overallOfficials': [{'name': 'Levent Horoz, Asisst Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kirsehir Ahi Evran Universitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahi Evran University Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist Prof', 'investigatorFullName': 'Levent Horoz', 'investigatorAffiliation': 'Ahi Evran University Education and Research Hospital'}}}}