Clinical trial NCT04235907: Telerehabilitation Following Ankle Fractures
Official title: Telerehabilitation Following Ankle Fractures: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fractures
Keywords: Rehabilitation
Telerehabilitation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Foundation for Orthopedic Trauma
First posted: 2020-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in self-reported function
timeFrame: At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months
Secondary outcomes:
measure: Change in self-reported quality of life
timeFrame: At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months
measure: Change in pain as assessed by the Brief Pain Inventory short form
timeFrame: At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months
measure: Patient Satisfaction as assessed by a 0-10 satisfaction scale
timeFrame: 6 months
measure: Out of pocket cost
timeFrame: 6 months
measure: Travel time (hours)
timeFrame: 6 months
measure: Fear of pain with movement as assessed by the Tampa Kinesiophobia Scale
timeFrame: 2 weeks
measure: Self-Efficacy for Home Exercise Program as assessed by a 12-Item questionnaire
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Kevin H McLaughlin, DPT
role: PRINCIPAL_INVESTIGATOR
References: