Telerehabilitation Following Ankle Fractures

Ankle Fractures Clinical Trial

Official title:

Telerehabilitation Following Ankle Fractures: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235907
• Other study ID #: IRB00210272
• Status: Completed
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

Intervention

Other:
• Telerehabilitation
Internet-guided rehabilitation with weekly phone calls from a physical therapist.
• Standard rehabilitation
Prescription for physical therapy and a printed list of exercises to complete.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Foundation for Orthopedic Trauma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Out of pocket cost	Patient reported estimate of patients' out of pocket costs associated with rehabilitation.	6 months
Secondary	Travel time (hours)	Patient reported estimate of time spent traveling to and from rehabilitation appointments.	6 months
Secondary	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
Secondary	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