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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Upper Limb Surgery; Occupational Therapy
• Intervention / Treatment: Other: occupational therapy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher Langhammer, MD; Phone Number: 4103286280; Email: CLanghammer@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • U of Maryland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: In-person occupational therapy; occupational therapy delivered in-person	Other: occupational 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
Active Comparator: Teletherapy; Video-conferencing occupational therapy	Other: occupational 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Christopher Langhammer, MD, U of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): November 13, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: December 24, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Occupational Therapy; Upper Limb Surgery; Upper Extremity Injury
• Other Study ID Numbers: HP-00094373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No