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Tele-rehabilitation in Patients Operated for Distal Radius Fracture

Primary Purpose

Distal Radius Fracture

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation
Face to face
Sponsored by
Ahi Evran University Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring telerehabilitation, distal radius fracture, functionality

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ahi Evran University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation

Face to face

Arm 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.

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.

Outcomes

Primary Outcome Measures

Wrist joint range of motion
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.
Wrist joint range of motion
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.
Wrist joint range of motion
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.
Environmental Measurement
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.
Environmental Measurement
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.
Environmental Measurement
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.
Quick-DASH
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
Quick-DASH
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
Quick-DASH
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
Coarse Grip Strength
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.
Coarse Grip Strength
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.
Coarse Grip Strength
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.
Patient-Rated Wrist Evaluation (PRWE) questionnaire
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.
Patient-Rated Wrist Evaluation (PRWE) questionnaire
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.
Patient-Rated Wrist Evaluation (PRWE) questionnaire
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.
pinch grip strength.
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).
pinch grip strength.
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).
pinch grip strength.
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).

Secondary Outcome Measures

Full Information

First Posted
September 9, 2022
Last Updated
May 11, 2023
Sponsor
Ahi Evran University Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05537493
Brief Title
Tele-rehabilitation in Patients Operated for Distal Radius Fracture
Official Title
Efficiency of Telerehabilitation in Patients Operated With the Diagnosis of Distal Radius Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
April 11, 2023 (Actual)
Study Completion Date
May 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahi Evran University Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
telerehabilitation, distal radius fracture, functionality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Romdomised controlled
Masking
Outcomes Assessor
Masking Description
Evaluator is blind to study groups
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation
Arm Type
Experimental
Arm 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.
Arm Title
Face to face
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
It will be followed by exercising on whatsapp
Intervention Type
Other
Intervention Name(s)
Face to face
Intervention Description
It will be followed by face to face
Primary Outcome Measure Information:
Title
Wrist joint range of motion
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.
Time Frame
0 day
Title
Wrist joint range of motion
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.
Time Frame
6 th week
Title
Wrist joint range of motion
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.
Time Frame
12 th week
Title
Environmental Measurement
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.
Time Frame
0 day
Title
Environmental Measurement
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.
Time Frame
6 th week
Title
Environmental Measurement
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.
Time Frame
12th week
Title
Quick-DASH
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
Time Frame
0 day
Title
Quick-DASH
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
Time Frame
6th week
Title
Quick-DASH
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
Time Frame
12th week
Title
Coarse Grip Strength
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.
Time Frame
0 day
Title
Coarse Grip Strength
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.
Time Frame
6th week
Title
Coarse Grip Strength
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.
Time Frame
12th week
Title
Patient-Rated Wrist Evaluation (PRWE) questionnaire
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.
Time Frame
0 day
Title
Patient-Rated Wrist Evaluation (PRWE) questionnaire
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.
Time Frame
6th day
Title
Patient-Rated Wrist Evaluation (PRWE) questionnaire
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.
Time Frame
12th week
Title
pinch grip strength.
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).
Time Frame
0 day
Title
pinch grip strength.
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).
Time Frame
6 th week
Title
pinch grip strength.
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).
Time Frame
12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Levent Horoz, Asisst Prof
Organizational Affiliation
Kirsehir Ahi Evran Universitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahi Evran University
City
Kirşehir
State/Province
City Centre
ZIP/Postal Code
40100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26940798
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.
Results Reference
background
PubMed Identifier
32197766
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.
Results Reference
background
PubMed Identifier
28449618
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.
Results Reference
background

Learn more about this trial

Tele-rehabilitation in Patients Operated for Distal Radius Fracture

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