Effectiveness of Virtual Reality in Hand Therapy

Distal Radius Fracture Clinical Trial

Official title:

Virtual Reality in Hand Therapy Effectiveness and Implementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05188040
• Other study ID #: 72833
• Status: Completed
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the use of Virtual Reality as an intervention for patients following specific hand injuries will positively affect patients with decreased hand function and reduce pain and improve outcomes. Participants will be recruited from 3 different clinics in central Kentucky.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 1, 2023
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Attending hand therapy for rehabilitation of an upper extremity injury with a diagnosis of distal radius fracture, complex regional pain syndrome or tendon ruptures

2. Must be in an active exercise phase of rehabilitation

Exclusion Criteria:

1. Not in a phase in their rehabilitation in which they can perform active exercises

2. Having arm injury due to a neurological disorder (stroke, Multiple sclerosis, spinal cord injury, other)

3. Non-English speaking

4. Patient reporting a history of severe claustrophobia or motion sickness

Related Conditions & MeSH terms

• Chronic Regional Pain Syndrome
• Distal Radius Fracture
• Flexor Tendon Rupture
• Radius Fractures
• Rupture
• Wrist Fractures

Intervention

Other:
• Virtual Reality Exercises
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.

Locations

Country	Name	City	State
United States	Commonwealth Hand and Physical Therapy	Georgetown	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
Timothy Uhl	Commonwealth Hand and Physical Therapy, University of Kentucky

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hand Function Measures - Box and Block Test	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
Primary	Hand Function Measures - Nine Hole Peg Test	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	Quick Disability of Arm Shoulder and Hand (QDASH)	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
Secondary	Visual Analog Scale	Self-Report Pain Measure on a 0 - 10 scale.	1 minute
Secondary	Enjoyment Subscale of the Intrinsic Motivation Inventory scale	7 items on a subjective questionnaire (7 point Likert scale) - completed post intervention only	7 minutes