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

NCT04691739 | Withdrawn DMC

• 1 other identifier: HP-00094373
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Limb Surgery; Occupational Therapy

Keywords

Upper Limb Surgery; Upper Extremity Injury; Occupational Therapy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

In-person occupational therapy

ACTIVE COMPARATOR

occupational therapy delivered in-person

Other: occupational therapy

Teletherapy

ACTIVE COMPARATOR

Video-conferencing occupational therapy

Other: occupational therapy

Interventions

occupational therapy OTHER

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

In-person occupational therapy; Teletherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

U of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Arm Injuries

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Christopher Langhammer, MD

  U of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: December 31, 2020
• Study Start: January 10, 2022
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)