NCT05188040

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

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 10, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 16, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

December 10, 2021

Last Update Submit

November 20, 2023

Conditions

Keywords

Virtual RealityFunctionHand TherapyExercises

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Quick Disability of Arm Shoulder and Hand (QDASH)

    5 minutes

  • Visual Analog Scale

    1 minute

  • Enjoyment Subscale of the Intrinsic Motivation Inventory scale

    7 minutes

Study Arms (1)

Virtual Reality Intervention Group

EXPERIMENTAL

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.

Other: Virtual Reality Exercises

Interventions

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.

Virtual Reality Intervention Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Commonwealth Hand and Physical Therapy

Georgetown, Kentucky, 40324, United States

Location

Related Publications (10)

  • 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.

    PMID: 31009598BACKGROUND
  • 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.

    PMID: 28588464BACKGROUND
  • 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.

    PMID: 11587113BACKGROUND
  • 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.

    PMID: 2489825BACKGROUND
  • 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.

    PMID: 24456057BACKGROUND
  • 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.

    PMID: 30503231BACKGROUND
  • 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.

    PMID: 25889199BACKGROUND
  • 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.

    PMID: 31890259BACKGROUND
  • 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.

    PMID: 21264690BACKGROUND
  • 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.

    PMID: 32482376BACKGROUND

MeSH Terms

Conditions

Wrist FracturesComplex Regional Pain SyndromesMotor Activity

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneAutonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesBehavior

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tim L Uhl, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No Masking.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Participants at the Commonwealth Hand and Physical Therapy clinic with the 3 included arm and hand injury diagnoses will be offered the opportunity in a flyer at the clinic to participate in the VR study. Those consented will complete the pre and post outcome measures outlined within this document with the research team member. For intervention, the participants will be instructed by the treating therapist in standard of care rehabilitation and utilize Virtual Reality with the Oculus Quest 2 system as the active exercise component of their rehabilitation over approximately approximately 4 sessions, totally \~ 1-hour. The specific virtual reality games within the Oculus Quest 2 VR system will be selected by the therapist providing interventions each session. The virtual reality game allows for augmented visual feedback and will be directly supervised by the treating therapists.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 10, 2021

First Posted

January 12, 2022

Study Start

May 16, 2022

Primary Completion

July 19, 2023

Study Completion

November 1, 2023

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations