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Completed

NCT Number: NCT04235907

Telerehabilitation Following Ankle Fractures

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telerehabilitation

Other

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

Standard Rehabilitation

Other

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

Primary outcomes

  1. Change in self-reported function

    Time frame: At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months

    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.

Secondary outcomes

  1. Change in self-reported quality of life

    Time frame: At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months

    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.

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

    Time frame: At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months

    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.

  3. Patient Satisfaction as assessed by a 0-10 satisfaction scale

    Time frame: 6 months

    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.

  4. Out of pocket cost

    Time frame: 6 months

    Patient reported estimate of patients' out of pocket costs associated with rehabilitation.

  5. Travel time (hours)

    Time frame: 6 months

    Patient reported estimate of time spent traveling to and from rehabilitation appointments.

  6. Fear of pain with movement as assessed by the Tampa Kinesiophobia Scale

    Time frame: 2 weeks

    17-Item patient questionnaire assessing fear of movement. Scores range from 17-68 with higher scores indicating increased fear of pain with movement.

  7. Self-Efficacy for Home Exercise Program as assessed by a 12-Item questionnaire

    Time frame: 2 weeks

    12-Item questionnaire assessing self-efficacy for completing assigned home exercises. Scored 0-72 with higher scores indicating increased self-efficacy.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Foundation for Orthopedic Trauma

Registry information

Official study title

Telerehabilitation Following Ankle Fractures: A Pilot Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2020
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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