Clinical trial NCT04691739: Teletherapy for Upper Extremity Fracture Rehabilitation (TELE-REHAB Study)
Official title: Teletherapy for Upper Extremity Fracture Rehabilitation, A Pilot Randomized Controlled Trial (TELE-REHAB Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Upper Limb Surgery
Occupational Therapy
Keywords: Upper Limb Surgery
Upper Extremity Injury
Occupational Therapy
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility outcome 1: Enrollment rate
timeFrame: At 12 months
measure: Feasibility outcome 2a: Completion rate
timeFrame: at 6 weeks
measure: Feasibility outcome 2b: Completion rate
timeFrame: at 3 months
measure: Feasibility outcome 2c: Completion rate
timeFrame: at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: U of Maryland
state: Maryland
Study officials:
affiliation: U of Maryland, Baltimore
name: Christopher Langhammer, MD
role: PRINCIPAL_INVESTIGATOR
References: