NCT05537493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2023

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

September 9, 2022

Last Update Submit

May 11, 2023

Conditions

Distal Radius Fracture

Keywords

telerehabilitationdistal radius fracturefunctionality

Outcome Measures

Primary Outcomes (18)

  • 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.

    0 day

  • 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.

    6 th week

  • 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.

    12 th week

  • 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.

    0 day

  • 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.

    6 th week

  • 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.

    12th week

  • 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

    0 day

  • 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

    6th week

  • 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

    12th week

  • 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.

    0 day

  • 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.

    6th week

  • 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.

    12th week

  • 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.

    0 day

  • 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.

    6th day

  • 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.

    12th week

  • 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).

    0 day

  • 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).

    6 th week

  • 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).

    12th week

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

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.

Other: Telerehabilitation

Face to face

ACTIVE COMPARATOR

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.

Other: Face to face

Interventions

TelerehabilitationOTHER

It will be followed by exercising on whatsapp

Telerehabilitation
Face to faceOTHER

It will be followed by face to face

Face to face

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahi Evran University

Kirşehir, City Centre, 40100, Turkey (Türkiye)

Location

Related Publications (3)

  • 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: 26940798BACKGROUND

  • 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: 32197766BACKGROUND

  • 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.

    PMID: 28449618BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Levent Horoz, Asisst Prof

    Kirsehir Ahi Evran Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Evaluator is blind to study groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Romdomised controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 13, 2022

Study Start

May 25, 2022

Primary Completion

April 11, 2023

Study Completion

May 11, 2023

Last Updated

May 15, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)