Extremity Fracture LowerVR-PTNCT03779425
VR-Based Physical Therapy Pilot Study
A study testing Virtual Reality Physical Therapy in people with Extremity Fracture Lower, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility and acceptability of using the virtual reality-based physical therapy platform in patients with extremity fracture. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Extremity Fracture Lower
- What is being tested?
- Virtual Reality Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2019to 20 Dec 2019
- 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
- 18-65 years old
- Diagnosed with an operative fracture of the femur and/or tibia
- referred to physical therapy as standard of care
Who cannot join
- Injury Severity Score(ISS) > 18
- bilateral lower extremity injuries that preclude crutch ambulation
- associated spine fractures
- Glasgow Coma scale (GCS) < 15 at time of discharge
- major peripheral nerve injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
The purpose of this study is to evaluate the feasibility and acceptability of using the virtual reality-based physical therapy platform in patients with extremity fracture.
- Conditions
- Extremity Fracture Lower
- Being tested
- Virtual Reality Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Physical TherapyOther
Participants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Physical Therapy | Experimental | Participants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session. Receives: Other: Virtual Reality Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction with the virtual reality based physical therapy platform. Patient satisfaction will be assessed using a questionnaire created for this study.
Measured: Assessed directly after virtual reality physical therapy session
Patient Preference
Patient preference for virtual reality-based physical therapy when compared to standard supervised office based physical therapy. Patient preference will be assessed using a questionnaire created for this study.
Measured: Assessed directly after virtual reality physical therapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start9 Mar 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extremity Fracture LowerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- KairosXR, AO North America
- Responsible party
- Principal investigator, Ida Leah Gitajn, Dartmouth-Hitchcock Medical Center
- Investigators
- Ida L Gitajn, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779425
- Sponsor's protocol ID
- D19021
- Acronym
- VR-PT
- Status last verified
- Jan 2020
- First submitted
- 13 Dec 2018
- Last updated
- 28 Jan 2020
- 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 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR-Based Physical Therapy Pilot Study
- ClinicalTrials.gov ID
- NCT03779425
- Acronym / sponsor ID
- VR-PT / D19021
- Conditions
- Extremity Fracture Lower
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- KairosXR, AO North America
- Study start
- 9 Mar 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 19 Dec 2018 (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.
The purpose of this study is to evaluate the feasibility and acceptability of using the virtual reality-based physical therapy platform in patients with extremity fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Physical Therapy | Experimental | Other: Virtual Reality Physical TherapyParticipants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years old
- Diagnosed with an operative fracture of the femur and/or tibia
- referred to physical therapy as standard of care
Key exclusion criteria (5 listed)
- Injury Severity Score(ISS) > 18
- bilateral lower extremity injuries that preclude crutch ambulation
- associated spine fractures
- Glasgow Coma scale (GCS) < 15 at time of discharge
- major peripheral nerve injury
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 |
|---|---|---|
| Virtual Reality Physical TherapyParticipants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session. | Other | Virtual Reality Physical Therapy |
Primary outcome
Patient satisfaction
Time frame: Assessed directly after virtual reality physical therapy session
Patient satisfaction with the virtual reality based physical therapy platform. Patient satisfaction will be assessed using a questionnaire created for this study.
Patient Preference
Time frame: Assessed directly after virtual reality physical therapy session
Patient preference for virtual reality-based physical therapy when compared to standard supervised office based physical therapy. Patient preference will be assessed using a questionnaire created for this study.
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 28 Jan 2020.
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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.
Ida L Gitajn, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Physical Therapy in people with Extremity Fracture Lower, run by Dartmouth-Hitchcock Medical Center at 1 site 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 5 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 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Patient satisfaction (time frame: Assessed directly after virtual reality physical therapy session). The study lists 2 primary outcomes in all. 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 28 Jan 2020.