NCT05332080

Brief Summary

Objective: To determine the effectiveness of telerehabilitation versus supervised therapy in the functional recovery of patients with distal radius fracture. Design: A randomized, controlled, parallel-treatment trial protocol was performed to compare functional recovery after a telerehabilitation program vs supervised rehabilitation in patients with distal radius fracture. Setting: Participants: A total of 91 patients with distal radius fractures grades AO23 A and B. Interventions: the supervised rehabilitation group received for two weeks a 10-session program that included external heat application, stretching, mobilization, strengthening, and occupational therapy. The telerehabilitation group was given instructions to apply hydrotherapy, perform mobility and wrist and hand strengthening exercises for four weeks, using the Moodle application on their cell phone. Main outcomes measures: Outcome measures were measured at the time of admission to rehabilitation and 1, 3, and 6 months; at each follow-up visit, functionality, active range of motion, fist grip strength, quality of life and pain were measured. Results: When the results obtained at the beginning and at six months were compared, both groups presented statistically significant changes in the clinical variables analyzed but with greater functionality in the telerehabilitation group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

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

November 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

April 5, 2022

Last Update Submit

October 21, 2022

Conditions

Keywords

Telerehabilitationphysical therapydistal radius fracture

Outcome Measures

Primary Outcomes (1)

  • Outcome of baseline measures of wrist function and changes at 4, 12 and 24 weeks

    The measures physical function and symptoms in people with musculoskeletal disorders of the upper limb, specifically the wrist, was measured with Disabilities of the Arm, Shoulder and Hand questionnaire, a higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score test ranges from 0 (no disability) to 100 (most severe disability)

    At baseline and subsequently at 4, 12, and 24 weeks

Secondary Outcomes (1)

  • Outcome of baseline measures of quality of life and changes at 4, 12 and 24 weeks

    At baseline and subsequently at 4, 12, and 24 weeks

Study Arms (2)

Telerehabilitation via application on cell phone

EXPERIMENTAL

The patients in this group had application installed on their cell phones to access the online content, where they received advice on self-care and the type of exercises to be performed. The program consisted of hydrotherapy, mobility exercises, muscle strengthening, and activities to improve wrist and hand function, with planned 4-week objectives. Participants in both groups were provided with written exercise material, training, and advice on how to return to work and leisure activities. Each patient made a weekly record of the therapy he/she performed, including the day, type, and time of development of his/her exercises

Procedure: Telerehabilitation via application on cell phone

In-person rehabilitation

NO INTERVENTION

The patients in this group received an in-person rehabilitation program and was considered the control group, this group received for two weeks a 10-session program for two weeks that included external heat application, stretching, mobilization, strengthening, and occupational therapy. Moreover, it was complemented with occupational therapy focused on improving essential functions and strengthening extrinsic and intrinsic hand musculature, effectiveness in wrist mobility, and simulation of specific activities for reincorporation to work

Interventions

Realization of rehabilitation through content in an app they received advice on self-care and the type of exercises to do. The program consisted of hydrotherapy, mobility exercises, muscle strengthening, and activities to improve wrist and hand function, with planned goals.

Telerehabilitation via application on cell phone

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women older than 15 years
  • With closed distal radius fracture type AO23 A and B
  • Immobilization for six weeks (with or without surgical fixation)
  • With indication by the orthopedic physician to perform rehabilitation
  • Have a cell phone and internet access

You may not qualify if:

  • Patients with distal radius fractures with any of the following radiographic findings: volar tilt \>12°, radial tilt \>23° and radial height \>12 mm
  • Patients with neurological problems, illiteracy, presence of pressure ulcers in the distal third of the forearm or hand that did not heal, users of orally or intravenously administered steroids, patients with pre-existing and concomitant arthritis or osteoarthritis of the wrist, or history of injury. Subjects with less than 80% adherence to treatment were eliminated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Mexicano del Seguro Social, HGR 1

Mérida, Yucatán, 97150, Mexico

Location

Related Publications (28)

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    PMID: 21705154BACKGROUND
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    PMID: 18590855BACKGROUND
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    PMID: 19345766BACKGROUND
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    PMID: 16136342BACKGROUND
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    PMID: 9266044BACKGROUND
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    PMID: 10968529BACKGROUND
  • Handoll HH, Elliott J. Rehabilitation for distal radial fractures in adults. Cochrane Database Syst Rev. 2015 Sep 25;2015(9):CD003324. doi: 10.1002/14651858.CD003324.pub3.

    PMID: 26403335BACKGROUND
  • Tenforde AS, Iaccarino MA, Borgstrom H, Hefner JE, Silver J, Ahmed M, Babu AN, Blauwet CA, Elson L, Eng C, Kotler D, Homer S, Makovitch S, McInnis KC, Vora A, Borg-Stein J. Telemedicine During COVID-19 for Outpatient Sports and Musculoskeletal Medicine Physicians. PM R. 2020 Sep;12(9):926-932. doi: 10.1002/pmrj.12422. Epub 2020 Jul 10.

    PMID: 32424977BACKGROUND
  • Turolla A, Rossettini G, Viceconti A, Palese A, Geri T. Musculoskeletal Physical Therapy During the COVID-19 Pandemic: Is Telerehabilitation the Answer? Phys Ther. 2020 Aug 12;100(8):1260-1264. doi: 10.1093/ptj/pzaa093. No abstract available.

    PMID: 32386218BACKGROUND
  • Gunther CM, Burger A, Rickert M, Crispin A, Schulz CU. Grip strength in healthy caucasian adults: reference values. J Hand Surg Am. 2008 Apr;33(4):558-65. doi: 10.1016/j.jhsa.2008.01.008.

    PMID: 18406961BACKGROUND
  • Egund L, Onnby K, Mcguigan F, Akesson K. Disability and Pain are the Best Predictors of Sick Leave After a Distal Radius Fracture in Men. J Occup Rehabil. 2020 Dec;30(4):656-664. doi: 10.1007/s10926-020-09880-4.

    PMID: 32052265BACKGROUND
  • Azad A, Kang HP, Alluri RK, Vakhshori V, Kay HF, Ghiassi A. Epidemiological and Treatment Trends of Distal Radius Fractures across Multiple Age Groups. J Wrist Surg. 2019 Aug;8(4):305-311. doi: 10.1055/s-0039-1685205. Epub 2019 Apr 16.

    PMID: 31404224BACKGROUND
  • Rundgren J, Bojan A, Mellstrand Navarro C, Enocson A. Epidemiology, classification, treatment and mortality of distal radius fractures in adults: an observational study of 23,394 fractures from the national Swedish fracture register. BMC Musculoskelet Disord. 2020 Feb 8;21(1):88. doi: 10.1186/s12891-020-3097-8.

    PMID: 32035488BACKGROUND
  • Sander AL, Leiblein M, Sommer K, Marzi I, Schneidmuller D, Frank J. Epidemiology and treatment of distal radius fractures: current concept based on fracture severity and not on age. Eur J Trauma Emerg Surg. 2020 Jun;46(3):585-590. doi: 10.1007/s00068-018-1023-7. Epub 2018 Oct 1.

    PMID: 30276724BACKGROUND
  • Wakefield AE, McQueen MM. The role of physiotherapy and clinical predictors of outcome after fracture of the distal radius. J Bone Joint Surg Br. 2000 Sep;82(7):972-6. doi: 10.1302/0301-620x.82b7.10377.

    PMID: 11041584BACKGROUND
  • Challis MJ, Jull GJ, Stanton WR, Welsh MK. Cyclic pneumatic soft-tissue compression enhances recovery following fracture of the distal radius: a randomised controlled trial. Aust J Physiother. 2007;53(4):247-52. doi: 10.1016/s0004-9514(07)70005-3.

    PMID: 18047459BACKGROUND
  • Kay S, Haensel N, Stiller K. The effect of passive mobilisation following fractures involving the distal radius: a randomised study. Aust J Physiother. 2000;46(2):93-101. doi: 10.1016/s0004-9514(14)60317-2.

    PMID: 11676793BACKGROUND
  • Lara TR, Kagan RP, Hiratzka SL, Thompson AR, Nazir OF, Mirarchi AJ. Traditional Versus Digital Media-Based Hand Therapy After Distal Radius Fracture. J Hand Surg Am. 2022 Mar;47(3):291.e1-291.e8. doi: 10.1016/j.jhsa.2021.06.018. Epub 2021 Aug 6.

    PMID: 34366180BACKGROUND
  • Andrade-Silva FB, Rocha JP, Carvalho A, Kojima KE, Silva JS. Influence of postoperative immobilization on pain control of patients with distal radius fracture treated with volar locked plating: A prospective, randomized clinical trial. Injury. 2019 Feb;50(2):386-391. doi: 10.1016/j.injury.2018.12.001. Epub 2018 Dec 4.

    PMID: 30558805BACKGROUND
  • Pasila M, Sundholm A. Mobilization of stiff hands after 104 Colles' fractures: a comparison between the value of the Movelat and its base cream. Rheumatol Rehabil. 1980 Aug;19(3):170-2. doi: 10.1093/rheumatology/19.3.170. No abstract available.

    PMID: 7414186BACKGROUND
  • Lyngcoln A, Taylor N, Pizzari T, Baskus K. The relationship between adherence to hand therapy and short-term outcome after distal radius fracture. J Hand Ther. 2005 Jan-Mar;18(1):2-8; quiz 9. doi: 10.1197/j.jht.2004.10.008.

    PMID: 15674780BACKGROUND
  • Souer JS, Buijze G, Ring D. A prospective randomized controlled trial comparing occupational therapy with independent exercises after volar plate fixation of a fracture of the distal part of the radius. J Bone Joint Surg Am. 2011 Oct 5;93(19):1761-6. doi: 10.2106/JBJS.J.01452.

    PMID: 22005860BACKGROUND
  • Upadhyaya GK, Iyengar K, Jain VK, Vaishya R. Challenges and strategies in management of osteoporosis and fragility fracture care during COVID-19 pandemic. J Orthop. 2020 Jun 2;21:287-290. doi: 10.1016/j.jor.2020.06.001. eCollection 2020 Sep-Oct.

    PMID: 32523258BACKGROUND
  • Moore CM, Leonardi-Bee J. The prevalence of pain and disability one year post fracture of the distal radius in a UK population: a cross sectional survey. BMC Musculoskelet Disord. 2008 Sep 29;9:129. doi: 10.1186/1471-2474-9-129.

    PMID: 18823546BACKGROUND
  • MacIntyre NJ, Dewan N. Epidemiology of distal radius fractures and factors predicting risk and prognosis. J Hand Ther. 2016 Apr-Jun;29(2):136-45. doi: 10.1016/j.jht.2016.03.003.

    PMID: 27264899BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, controlled, parallel-treatment trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 18, 2022

Study Start

November 1, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

October 24, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations