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

Occupational Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04691739
• Other study ID #: HP-00094373
• Status: Withdrawn
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: November 13, 2023

Study information

• Verified date: November 2023
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 13, 2023
• Est. primary completion date: November 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Occupational Therapy
• Upper Limb Surgery

Intervention

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

Locations

Country	Name	City	State
United States	U of Maryland	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

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