Virtual Reality in Hand Therapy

Sponsor

Timothy Uhl (Other)

Overall Status

Recruiting

CT.gov ID

NCT05188040

Collaborator

University of Kentucky (Other), Commonwealth Hand and Physical Therapy (Other)

200

Enrollment

Location

Arm

42.5

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fracture Chronic Regional Pain Syndrome Flexor Tendon Rupture	Other: Virtual Reality Exercises	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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.

Primary Purpose:

Treatment

Official Title:

Virtual Reality in Hand Therapy Effectiveness and Implementation

Actual Study Start Date :

May 16, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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.	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.

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.

Other: Virtual Reality Exercises

Outcome Measures

Primary Outcome Measures

Hand Function Measures - Box and Block Test [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.
Hand Function Measures - Nine Hole Peg Test [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.

Secondary Outcome Measures

Quick Disability of Arm Shoulder and Hand (QDASH) [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.
Visual Analog Scale [1 minute]
Self-Report Pain Measure on a 0 - 10 scale.
Enjoyment Subscale of the Intrinsic Motivation Inventory scale [7 minutes]
7 items on a subjective questionnaire (7 point Likert scale) - completed post intervention only

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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