Telerehabilitation Following Ankle Fractures

Telerehabilitation Following Ankle Fractures: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Ankle Fractures
• Intervention / Treatment: Other: Standard rehabilitation; Other: Telerehabilitation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional Physical Therapy; 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; Prescription for physical therapy and a printed list of exercises to complete.
Active Comparator: Telerehabilitation; 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; Internet-guided rehabilitation with weekly phone calls from a physical therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-reported quality of life	Measured using the Veterans RAND 12-Item Health Survey. This is a 12-Item global health questionnaire with a physical and mental component scores. Utilizes a t-score method standardized to the US population. Positive t-scores indicate better than average quality of life and negative t-score values represent lower than average 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	Measured using the Brief Pain Inventory short form. This is a 15-item questionnaire resulting in scores for pain severity and pain interference. Each of these is scored 0-10 with higher scores indicating increased pain severity/interference.	At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months
Patient Satisfaction as assessed by a 0-10 satisfaction scale	Patient reported measure of satisfaction with treatment received and progress made while recovering from injury. Will be measured on a scale of 0-10, with higher scores indicating increased satisfaction with treatment.	6 months
Out of pocket cost	Patient reported estimate of patients' out of pocket costs associated with rehabilitation.	6 months
Travel time (hours)	Patient reported estimate of time spent traveling to and from rehabilitation appointments.	6 months
Fear of pain with movement as assessed by the Tampa Kinesiophobia Scale	17-Item patient questionnaire assessing fear of movement. Scores range from 17-68 with higher scores indicating increased fear of pain with movement.	2 weeks
Self-Efficacy for Home Exercise Program as assessed by a 12-Item questionnaire	12-Item questionnaire assessing self-efficacy for completing assigned home exercises. Scored 0-72 with higher scores indicating increased self-efficacy.	2 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Foundation for Orthopedic Trauma
• Investigators: Principal Investigator: Kevin H McLaughlin, DPT, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Telerehabilitation
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: IRB00210272

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No