- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05188040
Effectiveness of Virtual Reality in Hand Therapy
Virtual Reality in Hand Therapy Effectiveness and Implementation
Study Overview
Status
Intervention / Treatment
Detailed Description
Participants will participate in four sessions of therapy treatment over a 2-3 week time span of schedule therapy appointments during their active phase of rehabilitation for approximately 1-hour virtual reality (VR) training dosage which will be recorded. The specific virtual reality games within the Oculus Quest 2 VR system will be selected by the therapist providing interventions each session.
In addition to the Virtual Reality intervention noted above, participants will participate in a pre and post-test outcome measure session (25-30 minutes) with a research team member. (See outcome measure section for more details).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
-
Georgetown, Kentucky, United States, 40324
- Commonwealth Hand and Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Attending hand therapy for rehabilitation of an upper extremity injury with a diagnosis of distal radius fracture, complex regional pain syndrome or tendon ruptures
- Must be in an active exercise phase of rehabilitation
Exclusion Criteria:
- Not in a phase in their rehabilitation in which they can perform active exercises
- Having arm injury due to a neurological disorder (stroke, Multiple sclerosis, spinal cord injury, other)
- Non-English speaking
- Patient reporting a history of severe claustrophobia or motion sickness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Intervention Group
Hand Therapy Exercises utilizing Oculus Quest 2 VR system with augmented feedback for patient to perform active hand therapy.
Specific interventions / games will be selected by the participants individual therapist.
|
Hand Therapy Exercises utilizing Oculus Quest 2 VR system with augmented feedback for patient to perform active hand therapy.
Specific interventions / games will be selected by the participants individual therapist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand Function Measures - Box and Block Test
Time Frame: 4 minutes
|
The patient is asked to grasp a single block out of one box and move the block into the other box.
They must cross midline to drop the box into the other box.
This is a timed test for 1 minute.
The number of blocks moved are counted and then the test is repeated with the other hand.
A 15 second trial practice is performed so the participant understands the test.
The number of blocks move with each hand is recorded.
|
4 minutes
|
|
Hand Function Measures - Nine Hole Peg Test
Time Frame: 8 minutes
|
Nine Hole Peg Test measures finger dexterity and motor function.
The participants will take 9 pegs from a container and place into a board as quickly as possible and then return them back to the container.
A practice trial of this assessment will also occur prior to the documented time trial.
|
8 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quick Disability of Arm Shoulder and Hand (QDASH)
Time Frame: 5 minutes
|
Quick DASH (QDASH) subjective report measure is an 11-item questionnaire to indicate the level of disability a person is currently having given their injury.
It is scored from 0-100 with 0 representing no disability and 100 indicating the have severe disability.
A lower score is a better score on this outcome measure.
|
5 minutes
|
|
Visual Analog Scale
Time Frame: 1 minute
|
Self-Report Pain Measure on a 0 - 10 scale.
|
1 minute
|
|
Enjoyment Subscale of the Intrinsic Motivation Inventory scale
Time Frame: 7 minutes
|
7 items on a subjective questionnaire (7 point Likert scale) - completed post intervention only
|
7 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tim L Uhl, PhD, University of Kentucky
Publications and helpful links
General Publications
- McAuley E, Duncan T, Tammen VV. Psychometric properties of the Intrinsic Motivation Inventory in a competitive sport setting: a confirmatory factor analysis. Res Q Exerc Sport. 1989 Mar;60(1):48-58. doi: 10.1080/02701367.1989.10607413.
- Hoffman HG, Patterson DR, Carrougher GJ, Sharar SR. Effectiveness of virtual reality-based pain control with multiple treatments. Clin J Pain. 2001 Sep;17(3):229-35. doi: 10.1097/00002508-200109000-00007.
- Hoffman HG, Chambers GT, Meyer WJ 3rd, Arceneaux LL, Russell WJ, Seibel EJ, Richards TL, Sharar SR, Patterson DR. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann Behav Med. 2011 Apr;41(2):183-91. doi: 10.1007/s12160-010-9248-7.
- Cuthbert JP, Staniszewski K, Hays K, Gerber D, Natale A, O'Dell D. Virtual reality-based therapy for the treatment of balance deficits in patients receiving inpatient rehabilitation for traumatic brain injury. Brain Inj. 2014;28(2):181-8. doi: 10.3109/02699052.2013.860475.
- Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1.
- Tefertiller C, Hays K, Natale A, O'Dell D, Ketchum J, Sevigny M, Eagye CB, Philippus A, Harrison-Felix C. Results From a Randomized Controlled Trial to Address Balance Deficits After Traumatic Brain Injury. Arch Phys Med Rehabil. 2019 Aug;100(8):1409-1416. doi: 10.1016/j.apmr.2019.03.015. Epub 2019 Apr 19.
- Palaus M, Marron EM, Viejo-Sobera R, Redolar-Ripoll D. Neural Basis of Video Gaming: A Systematic Review. Front Hum Neurosci. 2017 May 22;11:248. doi: 10.3389/fnhum.2017.00248. eCollection 2017.
- Glegg SMN, Levac DE. Barriers, Facilitators and Interventions to Support Virtual Reality Implementation in Rehabilitation: A Scoping Review. PM R. 2018 Nov;10(11):1237-1251.e1. doi: 10.1016/j.pmrj.2018.07.004.
- Fowler CA, Ballistrea LM, Mazzone KE, Martin AM, Kaplan H, Kip KE, Murphy JL, Winkler SL. A virtual reality intervention for fear of movement for Veterans with chronic pain: protocol for a feasibility study. Pilot Feasibility Stud. 2019 Dec 11;5:146. doi: 10.1186/s40814-019-0501-y. eCollection 2019.
- Hoffman HG, Boe DA, Rombokas E, Khadra C, LeMay S, Meyer WJ, Patterson S, Ballesteros A, Pitt SW. Virtual reality hand therapy: A new tool for nonopioid analgesia for acute procedural pain, hand rehabilitation, and VR embodiment therapy for phantom limb pain. J Hand Ther. 2020 Apr-Jun;33(2):254-262. doi: 10.1016/j.jht.2020.04.001. Epub 2020 May 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 72833
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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