Ankle FracturesNCT04235907
Telerehabilitation Following Ankle Fractures
A study testing Telerehabilitation and Standard rehabilitation in people with Ankle Fractures, run by Johns Hopkins University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Telerehabilitation and Standard rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bimalleolar or trimalleolar fracture
- Repaired with open reduction internal fixation technique
- Must have access to computer, tablet, or smart phone with internet access
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: Telerehabilitation Following Ankle Fractures: A Pilot Study
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.
- Conditions
- Ankle Fractures
- Being tested
- Telerehabilitation, Standard rehabilitation
- Keywords
- Rehabilitation, Telerehabilitation
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
Internet-guided rehabilitation with weekly phone calls from a physical therapist.
Standard rehabilitationOther
Prescription for physical therapy and a printed list of exercises to complete.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Physical Therapy | Active comparator | 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. Receives: Other: Standard rehabilitation |
| Telerehabilitation | Active comparator | 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. Receives: Other: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months
Secondary outcomes (7)
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.
Measured: At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months
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.
Measured: At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months
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.
Measured: 6 months
Out of pocket cost
Patient reported estimate of patients' out of pocket costs associated with rehabilitation.
Measured: 6 months
Travel time (hours)
Patient reported estimate of time spent traveling to and from rehabilitation appointments.
Measured: 6 months
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.
Measured: 2 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start28 Sep 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Orthopedic Trauma
- Responsible party
- Sponsor
- Investigators
- Kevin H McLaughlin, DPT, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235907
- Sponsor's protocol ID
- IRB00210272
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2020
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation Following Ankle Fractures: A Pilot Study
- ClinicalTrials.gov ID
- NCT04235907
- Acronym / sponsor ID
- IRB00210272
- Conditions
- Ankle Fractures
- Keywords
- Rehabilitation, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Foundation for Orthopedic Trauma
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Physical Therapy | Active comparator | Other: Standard rehabilitationPatients 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. |
| Telerehabilitation | Active comparator | Other: TelerehabilitationPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bimalleolar or trimalleolar fracture
- Repaired with open reduction internal fixation technique
- Must have access to computer, tablet, or smart phone with internet access
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationInternet-guided rehabilitation with weekly phone calls from a physical therapist. | Other | Telerehabilitation |
| Standard rehabilitationPrescription for physical therapy and a printed list of exercises to complete. | Other | Traditional Physical Therapy |
Primary outcome
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.
7 secondary outcomes
Change in self-reported quality of life
Time frame: At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months
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
Patient Satisfaction as assessed by a 0-10 satisfaction scale
Time frame: 6 months
Out of pocket cost
Time frame: 6 months
Travel time (hours)
Time frame: 6 months
Fear of pain with movement as assessed by the Tampa Kinesiophobia Scale
Time frame: 2 weeks
Self-Efficacy for Home Exercise Program as assessed by a 12-Item questionnaire
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin H McLaughlin, DPT principal investigator
Johns Hopkins School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and Standard rehabilitation in people with Ankle Fractures, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported function (time frame: At 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.