NCT03779425

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 9, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

December 13, 2018

Last Update Submit

January 27, 2020

Conditions

Extremity Fracture Lower

Outcome Measures

Primary Outcomes (2)

  • Patient satisfaction

    Patient satisfaction with the virtual reality based physical therapy platform. Patient satisfaction will be assessed using a questionnaire created for this study.

    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.

    Assessed directly after virtual reality physical therapy session

Study Arms (1)

Virtual Reality Physical Therapy

EXPERIMENTAL

Participants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session.

Other: Virtual Reality Physical Therapy

Interventions

Virtual Reality Physical TherapyOTHER

Participants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session.

Virtual Reality Physical Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Diagnosed with an operative fracture of the femur and/or tibia
  • referred to physical therapy as standard of care

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Study Officials

  • Ida L Gitajn, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

December 13, 2018

First Posted

December 19, 2018

Study Start

March 9, 2019

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

US(1)