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Telerehabilitation Following Ankle Fractures

Primary Purpose

Ankle Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telerehabilitation
Standard rehabilitation
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures focused on measuring Rehabilitation, Telerehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Bayview Medical Center
  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Traditional Physical Therapy

Telerehabilitation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Out of pocket cost
Patient reported estimate of patients' out of pocket costs associated with rehabilitation.
Travel time (hours)
Patient reported estimate of time spent traveling to and from rehabilitation appointments.
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.
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.

Full Information

First Posted
January 17, 2020
Last Updated
January 4, 2023
Sponsor
Johns Hopkins University
Collaborators
Foundation for Orthopedic Trauma
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1. Study Identification

Unique Protocol Identification Number
NCT04235907
Brief Title
Telerehabilitation Following Ankle Fractures
Official Title
Telerehabilitation Following Ankle Fractures: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Foundation for Orthopedic Trauma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures
Keywords
Rehabilitation, Telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Physical Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Telerehabilitation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
Internet-guided rehabilitation with weekly phone calls from a physical therapist.
Intervention Type
Other
Intervention Name(s)
Standard rehabilitation
Intervention Description
Prescription for physical therapy and a printed list of exercises to complete.
Primary Outcome Measure Information:
Title
Change in self-reported function
Description
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.
Time Frame
At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Change in self-reported quality of life
Description
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.
Time Frame
At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months
Title
Change in pain as assessed by the Brief Pain Inventory short form
Description
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.
Time Frame
At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months
Title
Patient Satisfaction as assessed by a 0-10 satisfaction scale
Description
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.
Time Frame
6 months
Title
Out of pocket cost
Description
Patient reported estimate of patients' out of pocket costs associated with rehabilitation.
Time Frame
6 months
Title
Travel time (hours)
Description
Patient reported estimate of time spent traveling to and from rehabilitation appointments.
Time Frame
6 months
Title
Fear of pain with movement as assessed by the Tampa Kinesiophobia Scale
Description
17-Item patient questionnaire assessing fear of movement. Scores range from 17-68 with higher scores indicating increased fear of pain with movement.
Time Frame
2 weeks
Title
Self-Efficacy for Home Exercise Program as assessed by a 12-Item questionnaire
Description
12-Item questionnaire assessing self-efficacy for completing assigned home exercises. Scored 0-72 with higher scores indicating increased self-efficacy.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin H McLaughlin, DPT
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Telerehabilitation Following Ankle Fractures

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