Clinical trial NCT05332080: Telerehabilitation in Distal Radius Fracture
Official title: FUNCTIONAL RECOVERY AFTER A TELEREHABILITATION PROGRAM IN PATIENTS WITH DISTAL RADIUS FRACTURE: A RANDOMIZED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Keywords: Telerehabilitation
physical therapy
distal radius fracture
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2022-04-18
Enrollment: 88
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, parallel-treatment trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Outcome of baseline measures of wrist function and changes at 4, 12 and 24 weeks
timeFrame: At baseline and subsequently at 4, 12, and 24 weeks
Secondary outcomes:
measure: Outcome of baseline measures of quality of life and changes at 4, 12 and 24 weeks
timeFrame: At baseline and subsequently at 4, 12, and 24 weeks
Other outcomes:
Locations:
city: Mérida
country: Mexico
facility: Instituto Mexicano del Seguro Social, HGR 1
state: Yucatán
Study officials:
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