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Effectiveness of Virtual Reality in Hand Therapy

Primary Purpose

Distal Radius Fracture, Chronic Regional Pain Syndrome, Flexor Tendon Rupture

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Exercises
Sponsored by
Timothy Uhl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring Virtual Reality, Function, Hand Therapy, Exercises

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Commonwealth Hand and Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Reality Intervention Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Visual Analog Scale
Self-Report Pain Measure on a 0 - 10 scale.
Enjoyment Subscale of the Intrinsic Motivation Inventory scale
7 items on a subjective questionnaire (7 point Likert scale) - completed post intervention only

Full Information

First Posted
December 10, 2021
Last Updated
May 10, 2023
Sponsor
Timothy Uhl
Collaborators
University of Kentucky, Commonwealth Hand and Physical Therapy
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1. Study Identification

Unique Protocol Identification Number
NCT05188040
Brief Title
Effectiveness of Virtual Reality in Hand Therapy
Official Title
Virtual Reality in Hand Therapy Effectiveness and Implementation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Timothy Uhl
Collaborators
University of Kentucky, Commonwealth Hand and Physical Therapy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture, Chronic Regional Pain Syndrome, Flexor Tendon Rupture
Keywords
Virtual Reality, Function, Hand Therapy, Exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
No Masking.
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hand Function Measures - Box and Block Test
Description
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.
Time Frame
4 minutes
Title
Hand Function Measures - Nine Hole Peg Test
Description
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.
Time Frame
8 minutes
Secondary Outcome Measure Information:
Title
Quick Disability of Arm Shoulder and Hand (QDASH)
Description
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.
Time Frame
5 minutes
Title
Visual Analog Scale
Description
Self-Report Pain Measure on a 0 - 10 scale.
Time Frame
1 minute
Title
Enjoyment Subscale of the Intrinsic Motivation Inventory scale
Description
7 items on a subjective questionnaire (7 point Likert scale) - completed post intervention only
Time Frame
7 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tim L Uhl, PhD
Phone
859-218-0858
Email
tluhl2@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Denise R O'Dell, DSc
Phone
859-218-0590
Email
Denise.ODell@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim L Uhl, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Commonwealth Hand and Physical Therapy
City
Georgetown
State/Province
Kentucky
ZIP/Postal Code
40324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim L Uhl, PhD
Phone
859-230-7841
Email
tluhl2@uky.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31009598
Citation
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Results Reference
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28588464
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.
Results Reference
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PubMed Identifier
11587113
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.
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PubMed Identifier
2489825
Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
30503231
Citation
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Results Reference
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PubMed Identifier
25889199
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.
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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.
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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.
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Effectiveness of Virtual Reality in Hand Therapy

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