Ankle Fractures
Conditions
Keywords
Rehabilitation, Telerehabilitation
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.
Interventions
OTHERTelerehabilitation
Internet-guided rehabilitation with weekly phone calls from a physical therapist.
OTHERStandard rehabilitation
Prescription for physical therapy and a printed list of exercises to complete.
Sponsors
Foundation for Orthopedic Trauma
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported function | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in pain as assessed by the Brief Pain Inventory short form | 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. |
| Patient Satisfaction as assessed by a 0-10 satisfaction scale | 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. |
| Out of pocket cost | 6 months | Patient reported estimate of patients' out of pocket costs associated with rehabilitation. |
| Change in self-reported quality of life | 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. |
| Fear of pain with movement as assessed by the Tampa Kinesiophobia Scale | 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. |
| Self-Efficacy for Home Exercise Program as assessed by a 12-Item questionnaire | 2 weeks | 12-Item questionnaire assessing self-efficacy for completing assigned home exercises. Scored 0-72 with higher scores indicating increased self-efficacy. |
| Travel time (hours) | 6 months | Patient reported estimate of time spent traveling to and from rehabilitation appointments. |
Countries
United States
Outcome results
None listed