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

Study Overview
=================
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.

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

Conditions
-----------------
Upper Limb Surgery, Occupational Therapy

Intervention / Treatment
-----------------
* Other: occupational therapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-person occupational therapy<br>occupational therapy delivered in-person | Other: occupational therapy<br>* 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<br>|
| Active Comparator: Teletherapy<br>Video-conferencing occupational therapy | Other: occupational therapy<br>* 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<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Upper Limb Surgery, Upper Extremity Injury, Occupational Therapy