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

Not Applicable

Withdrawn

• Conditions: Upper Limb Surgery; Occupational Therapy
• Interventions: Other: occupational therapy

• Registration Number: NCT04691739
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-24
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-31
• Study Start: 2022-01-10
• Status Verified: 2023-11
• Primary Completion: 2023-11-13
• Study Completion: 2023-11-13
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teletherapy	occupational therapy	Video-conferencing occupational therapy
In-person occupational therapy	occupational therapy	occupational therapy delivered in-person

Primary Outcome Measures

Name	Time	Method
Feasibility outcome 2b: Completion rate	at 3 months	A success threshold of 90% patient follow-up and case report forms
Feasibility outcome 2c: Completion rate	at 6 months	A success threshold of 90% patient follow-up and case report forms
Feasibility outcome 1: Enrollment rate	At 12 months	A success threshold of 40% enrollment of eligible patients
Feasibility outcome 2a: Completion rate	at 6 weeks	A success threshold of 90% patient follow-up and case report forms completion rates

Trial Locations

Locations (1)

U of Maryland; 🇺🇸 Baltimore, Maryland, United States