Telerehabilitation Following Ankle Fractures

Johns Hopkins University

Status: Completed

Conditions: Ankle Fractures

Treatments: Other: Telerehabilitation; Other: Standard rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04235907

IRB00210272

Details and patient eligibility

About

Background and Purpose: Ankle fractures represent one of the most common fractures in North America. Surgical fixation is often required in the presence of dislocation or instability and has been shown to have a high rate of success. Following surgical fixation, physical therapy is commonly utilized to assist in regaining function. Advice alone has been shown to be non-inferior to traditional physical therapy for patients post-ankle fracture in two studies. The results of these studies have yet to be repeated in the US. It is the intent of this study to investigate the feasibility of a large clinical trial comparing the results of traditional physical therapy and an internet-based telerehabilitation program. Following surgical repair of ankle fractures, patients will be randomized to traditional rehabilitation or telerehabilitation. Telerehabilitation may represent an alternative patient option to traditional physical therapy following ankle fracture repair. The results of this study will inform the design of larger multi-site clinical trials investigating the effectiveness of telerehabilitation for this patient population.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bimalleolar or trimalleolar fracture
• Repaired with open reduction internal fixation technique
• Must have access to computer, tablet, or smart phone with internet access

Exclusion criteria

• Severe soft tissue damage associated with injury
• Physical or mental conditions that will affect patient's ability to participate in independent rehabilitation
• Non-English speaking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Traditional Physical Therapy

Active Comparator group

Description:

Patients will be given a prescription to see a physical therapist and a paper-based rehabilitation protocol. Patients will be allowed to receive physical therapy at a location of patients' choosing. This arm represents the current standard of care.

Treatment:

Other: Standard rehabilitation

Telerehabilitation

Active Comparator group

Description:

Patients will be given access to a website containing instructions with pictures and videos for the exercises patients are to complete as part of patients' rehabilitation. Patients will not be given a prescription to physical therapy. Patients in this group will receive weekly calls from a physical therapist during weeks 6-12 post-operatively.

Treatment:

Other: Telerehabilitation