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

NCT ID: NCT04691739

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2023-11-13

Brief Summary

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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

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Conditions

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Upper Limb Surgery Occupational Therapy

Keywords

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Upper Limb Surgery Upper Extremity Injury Occupational Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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In-person occupational therapy

occupational therapy delivered in-person

Group Type ACTIVE_COMPARATOR

occupational therapy

Intervention Type 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

Teletherapy

Video-conferencing occupational therapy

Group Type ACTIVE_COMPARATOR

occupational therapy

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Christopher Langhammer

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Langhammer, MD

Role: PRINCIPAL_INVESTIGATOR

U of Maryland, Baltimore

Locations

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U of Maryland

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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HP-00094373

Identifier Type: -

Identifier Source: org_study_id