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Distal Radius FractureNCT05332080

Telerehabilitation in Distal Radius Fracture

A study testing Telerehabilitation via application on cell phone in people with Distal Radius Fracture, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

Completed

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

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Distal Radius Fracture
What is being tested?
Telerehabilitation via application on cell phone
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteMexico
Study dates
1 Nov 2020to 30 Apr 2021
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Instituto Mexicano del Seguro Social, HGR 1

    Mérida, Yucatán, 97150

Other trials in Mexico

About this study

Official title: FUNCTIONAL RECOVERY AFTER A TELEREHABILITATION PROGRAM IN PATIENTS WITH DISTAL RADIUS FRACTURE: A RANDOMIZED CLINICAL TRIAL

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.

Read more

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.

Read the detailed description

Distal radius fractures (DRF) are among the most frequent fractures worldwide; in the United States, they are the second most common fracture in the upper limb, present an estimated annual incidence of 643,000 and represent 1.5% of consultations for hand and forearm fractures in emergency departments, after fractures of the radius and ulna. Their care implies an increase in the cost of care. In the United Kingdom, the National Health Services estimated an average expenditure of £1375.34 per day/patient, with surgical fixation of the FDR; in the USA, the Medicare system estimated a cost of more than $170 million for the care of these fractures. These patients are usually routinely referred to rehabilitation services after a variable period of immobilization, which increases the cost of care, with inpatient physiotherapy estimated to cost £82.03 per day and outpatient physiotherapy £40.70.

Despite various studies, it is still unclear which type of therapy has the most significant impact on the recovery of wrist function, range of motion, and strength. Currently, studies are showing that home programs are as effective as supervised rehabilitation programs; however, other studies show the opposite.

The Coronavirus disease (COVID-19) pandemic has imposed new paradigms of care for FDR, and now it is recommended to treat it as non-urgent and conservatively. Hence, it is necessary to establish rehabilitation strategies to continue caring for patients without exposing them to the risk of infection. In this sense, the World Confederation of Physical Therapy has proposed the digital practice of rehabilitation services (telemedicine). Therefore, the objective of this study was to determine the effectiveness of telerehabilitation versus supervised therapy in the functional recovery of patients with distal radius fractures.

Material and methods:

Approval was obtained for this study from the institutional review boards of the Hospital General Regional No.1 (R-2020-3201-153) and all patients consented to participate in the study and publication of the results.

Study Design and Intervention:

A randomized, controlled, parallel-treatment trial protocol was performed by using a computer-generated random number of table and concealed allocation (sequential, sealed envelopes filled by a person unconnected with the study), administered by the project coordinator after subject enrollment. Due to the nature of the intervention, neither the subjects nor the investigators were blinded to the intervention.

The first 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.

The second group members had the Moodle 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.

Patient Sample and Setting:

During the period November 2020 - April 2021, men and women older than 15 years were included, with closed distal radius fracture type AO23 A and B, after immobilization for six weeks (with or without surgical fixation), with indication by the orthopedic physician to perform rehabilitation, and who had a cell phone and internet access. Patients with distal radius fractures were excluded if they had 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.

Sample size calculation:

Fourteen points minimum difference on the Disabilities of the Arm, Shoulder, and Hand (DASH) scale, standard deviation of 20, a significance level of 5%, power of 80%, and an estimated loss of 20% were considered for the sample size calculation. The sample size was 44 subjects per group.

Procedures and equipment:

Each patient was assigned a folio number, integrating his or her file with sociodemographic, clinical, and functional data, obtained through the DASH, quality of life was measured with the 36-Item Short Form Survey (SF-36), for the measurement of the range of movement of the wrist, a commercial goniometer was used, and for the measurement of, the CAMRY electronic hand dynamometer, model: EH101 was used; for everyone, the arithmetic mean was calculated after three consecutive attempts, maintaining the maximum grip strength for 4 seconds, with an interval of 1 minute, as previously described, and for the evaluation of pain, the visual analog scale (VAS) was used.

Outcome assessment:

All participants were assessed for function, range of movement of the wrist, FPP, quality of life and pain at baseline and subsequently at 4, 12, and 24 weeks, irrespective of the degree of compliance with the experimental protocols.

Adherence: All the patients in group 1 reported having attended their therapies on time in their registry card, concluding the treatment cycles. In group 2, adherence was estimated to be between 80-90%, as evidenced by the number of clicks, the number of reproductions of each video, and the average time spent on the portal. The patients had to repeat the exercises at home daily, monitored with telephone calls, exercise diary, and checklist.

Statistical analysis:

Qualitative variables were analyzed with absolute and relative frequencies, quantitative variables with measures of central tendency and dispersion; for the comparison of quantitative variables between groups at the end of treatment, Student's t was used for independent samples.

The student T-test for paired samples was used to analyze intragroup dependent variables at the beginning and end of follow-up. Statistical significance was established at p<0.05. IBM-SPSS Software® v21 statistical/computer program was used for the analysis.

Being tested
Telerehabilitation via application on cell phone
Keywords
Telerehabilitation, physical therapy, distal radius fracture
Medical subject headings
Wrist Fractures

What participants receive

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

  • Telerehabilitation via application on cell phoneProcedure or surgery

    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.

Study groups in NCT05332080
Study groupRoleWhat they receive
Telerehabilitation via application on cell phoneExperimentalThe 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
Receives: Procedure: Telerehabilitation via application on cell phone
In-person rehabilitationNo interventionThe 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

What is being measured

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

  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)

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

Secondary outcomes (1)
  1. Outcome of baseline measures of quality of life and changes at 4, 12 and 24 weeks

    Quality of life is an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. It is a broad ranging concept affected in a complex way by the person's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment. The 36-item Short Form Survey was used for measure quality of life, with a test score ranging from 0 (worst quality of life) to 100 (best quality of life)

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

Timeline

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

  1. First posted18 Apr 2022
  2. Study start1 Nov 2020
  3. Primary completion30 Apr 2021
  4. Study completion30 Apr 2021

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
Randomized, controlled, parallel-treatment trial
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05332080
Sponsor's protocol ID
R-2020-3201-153
Status last verified
Oct 2022
First submitted
5 Apr 2022
Last updated
24 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mauck BM, Swigler CW. Evidence-Based Review of Distal Radius Fractures. Orthop Clin North Am. 2018 Apr;49(2):211-222. doi: 10.1016/j.ocl.2017.12.001.

    PubMed 29499822
  • Chung KC, Spilson SV. The frequency and epidemiology of hand and forearm fractures in the United States. J Hand Surg Am. 2001 Sep;26(5):908-15. doi: 10.1053/jhsu.2001.26322.

    PubMed 11561245
  • Tubeuf S, Yu G, Achten J, Parsons NR, Rangan A, Lamb SE, Costa ML. Cost effectiveness of treatment with percutaneous Kirschner wires versus volar locking plate for adult patients with a dorsally displaced fracture of the distal radius: analysis from the DRAFFT trial. Bone Joint J. 2015 Aug;97-B(8):1082-9. doi: 10.1302/0301-620X.97B8.35234.

    PubMed 26224825
  • Shauver MJ, Yin H, Banerjee M, Chung KC. Current and future national costs to medicare for the treatment of distal radius fracture in the elderly. J Hand Surg Am. 2011 Aug;36(8):1282-7. doi: 10.1016/j.jhsa.2011.05.017. Epub 2011 Jun 25.

    PubMed 21705154
  • Wong JY. Time off work in hand injury patients. J Hand Surg Am. 2008 May-Jun;33(5):718-25. doi: 10.1016/j.jhsa.2008.01.015.

    PubMed 18590855
  • Krischak GD, Krasteva A, Schneider F, Gulkin D, Gebhard F, Kramer M. Physiotherapy after volar plating of wrist fractures is effective using a home exercise program. Arch Phys Med Rehabil. 2009 Apr;90(4):537-44. doi: 10.1016/j.apmr.2008.09.575.

    PubMed 19345766
  • Maciel JS, Taylor NF, McIlveen C. A randomised clinical trial of activity-focussed physiotherapy on patients with distal radius fractures. Arch Orthop Trauma Surg. 2005 Oct;125(8):515-20. doi: 10.1007/s00402-005-0037-x. Epub 2005 Oct 22.

    PubMed 16136342
  • Oskarsson GV, Hjall A, Aaser P. Physiotherapy: an overestimated factor in after-treatment of fractures in the distal radius? Arch Orthop Trauma Surg. 1997;116(6-7):373-5. doi: 10.1007/BF00433993.

    PubMed 9266044
  • Watt CF, Taylor NF, Baskus K. Do Colles' fracture patients benefit from routine referral to physiotherapy following cast removal? Arch Orthop Trauma Surg. 2000;120(7-8):413-5. doi: 10.1007/pl00013772.

    PubMed 10968529
  • 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.

    PubMed 26403335
  • 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.

    PubMed 32424977
  • 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.

    PubMed 32386218
  • 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.

    PubMed 18406961
  • 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.

    PubMed 32052265
  • 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.

    PubMed 31404224

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation via application on cell phone in people with Distal Radius Fracture, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

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 5 inclusion and 2 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 24 Oct 2022. 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 Mexico. 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?

Outcome of baseline measures of wrist function and changes at 4, 12 and 24 weeks (time frame: At baseline and subsequently at 4, 12, and 24 weeks). 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 NCT05332080, which also lists 28 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 24 Oct 2022.

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