Distal Radius FractureNCT05188040
Effectiveness of Virtual Reality in Hand Therapy
A study testing Virtual Reality Exercises in people with Distal Radius Fracture and Chronic Regional Pain Syndrome, run by Timothy Uhl at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Distal Radius Fracture, Chronic Regional Pain Syndrome, Flexor Tendon Rupture
- What is being tested?
- Virtual Reality Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Commonwealth Hand and Physical Therapy
Georgetown, Kentucky, 40324
About this study
Official title: Virtual Reality in Hand Therapy Effectiveness and Implementation
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.
Read the 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).
- Being tested
- Virtual Reality Exercises
- Keywords
- Virtual Reality, Function, Hand Therapy, Exercises
- Medical subject headings
- Wrist Fractures, Complex Regional Pain Syndromes, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual Reality Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 minutes
Secondary outcomes (3)
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.
Measured: 5 minutes
Visual Analog Scale
Self-Report Pain Measure on a 0 - 10 scale.
Measured: 1 minute
Enjoyment Subscale of the Intrinsic Motivation Inventory scale
7 items on a subjective questionnaire (7 point Likert scale) - completed post intervention only
Measured: 7 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start16 May 2022
- Primary completion19 Jul 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy Uhl
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky, Commonwealth Hand and Physical Therapy
- Responsible party
- Sponsor-investigator, Timothy Uhl, University of Kentucky
- Investigators
- Tim L Uhl, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188040
- Sponsor's protocol ID
- 72833
- Status last verified
- Nov 2023
- First submitted
- 10 Dec 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31009598Palaus 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.
PubMed 28588464Hoffman 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.
PubMed 11587113McAuley 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.
PubMed 2489825Cuthbert 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.
PubMed 24456057Glegg 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.
PubMed 30503231Powell 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.
PubMed 25889199Fowler 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.
PubMed 31890259Hoffman 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.
PubMed 21264690Hoffman 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.
PubMed 32482376
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality in Hand Therapy Effectiveness and Implementation
- ClinicalTrials.gov ID
- NCT05188040
- Acronym / sponsor ID
- 72833
- Keywords
- Virtual Reality, Function, Hand Therapy, Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Timothy UhlUniversity, hospital or other
- Collaborators
- University of Kentucky, Commonwealth Hand and Physical Therapy
- Study start
- 16 May 2022 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Intervention Group | Experimental | Other: Virtual Reality ExercisesHand 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality ExercisesHand 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 Intervention Group |
Primary outcome
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.
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.
3 secondary outcomes
Quick Disability of Arm Shoulder and Hand (QDASH)
Time frame: 5 minutes
Visual Analog Scale
Time frame: 1 minute
Enjoyment Subscale of the Intrinsic Motivation Inventory scale
Time frame: 7 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 31009598Tefertiller 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.
- Background: PubMed 28588464Palaus 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.
- Background: PubMed 11587113Hoffman 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.
- Background: PubMed 2489825McAuley 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.
- Background: PubMed 24456057Cuthbert 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.
- Background: PubMed 30503231Glegg 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.
- Background: PubMed 25889199Powell 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.
- Background: PubMed 31890259Fowler 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.
- Background: PubMed 21264690Hoffman 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.
- Background: PubMed 32482376Hoffman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim L Uhl, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Exercises in people with Distal Radius Fracture and Chronic Regional Pain Syndrome, run by Timothy Uhl at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Function Measures - Box and Block Test (time frame: 4 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05188040, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.