- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05537493
Tele-rehabilitation in Patients Operated for Distal Radius Fracture
May 11, 2023 updated by: Levent Horoz, Ahi Evran University Education and Research Hospital
Efficiency of Telerehabilitation in Patients Operated With the Diagnosis of Distal Radius Fracture
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
City Centre
-
Kirşehir, City Centre, Turkey, 40100
- Ahi Evran University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Application of volar plate for distal radius fracture
- Patients not having undergone any surgery on that extremity before, not having an extremity defect that prevents rehabilitation
- Patients with normal pre-fracture cognitive functions
- Patients without major postoperative complications
Exclusion Criteria:
- Polytrauma
- Previous extremity-related surgery
- Injury in more than one anatomical region in the relevant extremity
- Patients living alone at home
- Malignancy, presence of known rheumatological disease, pregnancy
- Patients receiving any treatment other than the planned treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telerehabilitation
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.
|
It will be followed by exercising on whatsapp
|
|
Active Comparator: Face to face
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.
|
It will be followed by face to face
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wrist joint range of motion
Time Frame: 0 day
|
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.
|
0 day
|
|
Wrist joint range of motion
Time Frame: 6 th week
|
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.
|
6 th week
|
|
Wrist joint range of motion
Time Frame: 12 th week
|
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.
|
12 th week
|
|
Environmental Measurement
Time Frame: 0 day
|
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.
|
0 day
|
|
Environmental Measurement
Time Frame: 6 th week
|
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.
|
6 th week
|
|
Environmental Measurement
Time Frame: 12th week
|
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.
|
12th week
|
|
Quick-DASH
Time Frame: 0 day
|
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
|
0 day
|
|
Quick-DASH
Time Frame: 6th week
|
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
|
6th week
|
|
Quick-DASH
Time Frame: 12th week
|
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
|
12th week
|
|
Coarse Grip Strength
Time Frame: 0 day
|
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.
|
0 day
|
|
Coarse Grip Strength
Time Frame: 6th week
|
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.
|
6th week
|
|
Coarse Grip Strength
Time Frame: 12th week
|
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.
|
12th week
|
|
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Time Frame: 0 day
|
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.
|
0 day
|
|
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Time Frame: 6th day
|
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.
|
6th day
|
|
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Time Frame: 12th week
|
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.
|
12th week
|
|
pinch grip strength.
Time Frame: 0 day
|
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).
|
0 day
|
|
pinch grip strength.
Time Frame: 6 th week
|
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).
|
6 th week
|
|
pinch grip strength.
Time Frame: 12th week
|
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).
|
12th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Levent Horoz, Asisst Prof, Kirsehir Ahi Evran Universitesi
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2022
Primary Completion (Actual)
April 11, 2023
Study Completion (Actual)
May 11, 2023
Study Registration Dates
First Submitted
September 9, 2022
First Submitted That Met QC Criteria
September 9, 2022
First Posted (Actual)
September 13, 2022
Study Record Updates
Last Update Posted (Actual)
May 15, 2023
Last Update Submitted That Met QC Criteria
May 11, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAEK_2022-09/96
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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