AzTrials
AzTrials

Distal Radius FractureNCT05537493

Tele-rehabilitation in Patients Operated for Distal Radius Fracture

A study testing Telerehabilitation and Face to face in people with Distal Radius Fracture, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Distal Radius Fracture
What is being tested?
Telerehabilitation and Face to face
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 May 2022to 11 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ahi Evran University

    Kirşehir, City Centre, 40100

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Telerehabilitation, Face to face
Keywords
telerehabilitation, distal radius fracture, functionality
Medical subject headings
Wrist Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelerehabilitationOther

    It will be followed by exercising on whatsapp

  • Face to faceOther

    It will be followed by face to face

Study groups in NCT05537493
Study groupRoleWhat they receive
TelerehabilitationExperimentalVideos 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.
Receives: Other: Telerehabilitation
Face to faceActive comparatorA 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.
Receives: Other: Face to face

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0 day

  2. 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.

    Measured: 6 th week

  3. 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.

    Measured: 12 th week

  4. 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.

    Measured: 0 day

  5. 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.

    Measured: 6 th week

  6. 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.

    Measured: 12th week

  7. 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

    Measured: 0 day

  8. 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

    Measured: 6th week

  9. 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

    Measured: 12th week

  10. 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.

    Measured: 0 day

  11. 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.

    Measured: 6th week

  12. 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.

    Measured: 12th week

  13. 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.

    Measured: 0 day

  14. 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.

    Measured: 6th day

  15. 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.

    Measured: 12th week

  16. 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).

    Measured: 0 day

  17. 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).

    Measured: 6 th week

  18. 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).

    Measured: 12th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2022
  2. Study start25 May 2022
  3. Primary completion11 Apr 2023
  4. Study completion11 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Romdomised controlled
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05537493
Sponsor's protocol ID
KAEK_2022-09/96
Status last verified
May 2023
First submitted
9 Sep 2022
Last updated
15 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 26940798
  • 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.

    PubMed 32197766
  • 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.

    PubMed 28449618

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation and Face to face in people with Distal Radius Fracture, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wrist joint range of motion (time frame: 0 day). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05537493, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in