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Teletherapy for Upper Extremity Fracture Rehabilitation (TELE-REHAB Study)

Teletherapy for Upper Extremity Fracture Rehabilitation, A Pilot Randomized Controlled Trial (TELE-REHAB Study)

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04691739
Enrollment
0
Registered
2020-12-31
Start date
2022-01-10
Completion date
2023-11-13
Last updated
2023-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occupational Therapy, Upper Limb Surgery

Keywords

Upper Limb Surgery, Upper Extremity Injury, Occupational Therapy

Brief summary

Following upper limb surgeries, patients could receive occupational therapy either in-person or remotely (teletherapy). The investigators currently do not know which occupational therapy delivery is better in terms of clinical outcomes and patient recovery. The proposed study is a pilot randomized controlled trial (RCT) testing the feasibility of comparing in-person occupational therapy to teletherapy following operative fixation of upper extremity fracture. It is a single site, parallel-arm, randomized controlled trial to compare teletherapy versus in-person occupational therapy. Patients who are eligible will be randomized similar to a flip of a coin (1:1) to occupational therapy in-person or through a telemedicine platform. Patients would also complete surveys at each follow-up visit to measure clinical outcomes.

Interventions

OTHERoccupational therapy

occupational therapy sessions include a set of standardized test exercises plus additional modalities that are optimized to each patient's needs according to the clinical judgement of the treating therapist

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participants must have had operative fixation of upper extremity fracture located between the humeral shaft and distal radius (inclusive) who are indicated for outpatient occupational therapy. * Participants at least 18 years (≥ 18 years of age). * English-speaking participants

Exclusion criteria

* Participants unable to consent * Vulnerable populations including prisoners and marginally housed patients * Additional traumatic conditions that may affect the ultimate-use pattern of the injured limb including traumatic brain injury, spinal cord injury, peripheral nerve injury, or associated soft tissue injury requiring specific postoperative activity modifications. * Contralateral upper extremity injury that prevents participating in the standardized exercises. * Initiation of occupational therapy (OT) during an inpatient hospital stay * Pre-existing comorbidities that may interfere with communication or that may limit the use of standard telecommunications tools (sight/hearing impaired, speech impaired) * Patients without a smart-phone or internet access.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility outcome 1: Enrollment rateAt 12 monthsA success threshold of 40% enrollment of eligible patients
Feasibility outcome 2a: Completion rateat 6 weeksA success threshold of 90% patient follow-up and case report forms completion rates
Feasibility outcome 2b: Completion rateat 3 monthsA success threshold of 90% patient follow-up and case report forms
Feasibility outcome 2c: Completion rateat 6 monthsA success threshold of 90% patient follow-up and case report forms

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026