Telerehabilitation Following Ankle Fractures

NCT04235907 | Completed

• 1 other identifier: IRB00210272
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Ankle Fractures

Keywords

Rehabilitation; Telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in self-reported function

  Measured by the Lower Extremity Functional Scale, a patient-reported function of the lower extremity. Scores range from 0-80 with lower scores indicating increased impairment levels.

  At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months

Secondary Outcomes (7)

• Change in self-reported quality of life

  At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months

• Change in pain as assessed by the Brief Pain Inventory short form

  At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months

• Patient Satisfaction as assessed by a 0-10 satisfaction scale

  6 months

• Out of pocket cost

  6 months

• Travel time (hours)

  6 months

Study Arms (2)

Traditional Physical Therapy

ACTIVE COMPARATOR

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.

Other: Standard rehabilitation

Telerehabilitation

ACTIVE COMPARATOR

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.

Other: Telerehabilitation

Interventions

Telerehabilitation OTHER

Internet-guided rehabilitation with weekly phone calls from a physical therapist.

Telerehabilitation

Standard rehabilitation OTHER

Prescription for physical therapy and a printed list of exercises to complete.

Traditional Physical Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Foundation for Orthopedic Trauma: collaborator

Study Sites (2)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Ankle Fractures

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Kevin H McLaughlin, DPT

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 22, 2020
• Study Start: September 28, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 6, 2023

Record last verified: 2023-01

Locations

US (2)