Virtual Reality Exercises for Stroke Rehabilitation
(VALOR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new virtual reality exercise program, the VALOR Home Exercise Program (HEP), designed to assist individuals with arm mobility issues following a stroke. Participants will use a VR headset at home to practice daily activities and enhance arm movement. The study compares this VR program to the regular therapy participants already receive. Individuals who experienced a stroke over three months ago and have some hand movement may be suitable candidates. They must have adequate vision, with glasses if necessary, and be able to use the system safely at home. As an unphased trial, this study provides a unique opportunity to explore innovative therapy options that could enhance recovery and improve quality of life.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that the VALOR Home Exercise Program is safe for stroke rehabilitation?
Research has shown that the VALOR Home Exercise Program (HEP), which uses virtual reality (VR) for stroke recovery, is generally easy for participants to handle. Early results suggest that any side effects are manageable, making it a promising option for home recovery. Studies have found that VR training can improve movement control in stroke patients without causing major side effects. Although researchers are still testing this treatment, VR in rehabilitation has shown positive results in similar studies, supporting its safety and effectiveness for people with arm and hand difficulties after a stroke.12345
Why are researchers excited about this trial?
The VALOR Home Exercise Program (HEP) is unique because it uses virtual reality (VR) technology to aid stroke rehabilitation, offering an innovative way for patients to practice daily activities at home. Unlike traditional rehab methods that often require in-person therapy sessions, VALOR allows patients to engage in independent, guided exercises using a VR headset. This approach not only targets specific motor skills but also provides remote monitoring and adaptation of the treatment plan through a secure web application, ensuring personalized care. Researchers are excited about this trial as it explores the potential for enhanced engagement and faster recovery in stroke rehabilitation by leveraging cutting-edge VR technology.
What evidence suggests that the VALOR Home Exercise Program is effective for stroke rehabilitation?
Research has shown that exercise programs can aid stroke recovery by enhancing physical abilities, movement, and daily activities. Studies have found that personalized rehabilitation plans can boost balance, walking, and muscle strength. In this trial, participants may receive the VALOR Home Exercise Program, which uses virtual reality (VR) for guided exercises. This program has improved balance and physical abilities, suggesting it might also enhance arm and hand function after a stroke.678910
Are You a Good Fit for This Trial?
This trial is for adults who had a stroke at least 3 months ago and now have trouble using one hand or arm. Participants need to have enough vision (with glasses if needed), some movement in their affected arm, and a safe space at home for the VR system. People with severe muscle tightness, major health issues before the stroke, or serious vision problems can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-assessment
Participants undergo a pre-assessment visit involving administration of a battery of gold-standard UE function tests and headset fitting
Treatment
Participants in the VALOR HEP group use the VR system for UE practice at home, while UCT group continues usual care
Post-assessment
Participants return for a post-assessment visit to undergo the same battery of tests used in pre-assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment with a follow-up assessment approximately 3 months after post-assessment
What Are the Treatments Tested in This Trial?
Interventions
- VALOR Home Exercise Program (HEP)
Trial Overview
The study compares two ways of helping people recover use of their arms after a stroke: one group uses an immersive virtual reality (VR) exercise program called VALOR at home, while the other gets usual care treatment. The goal is to see if VR-guided exercises help more with daily activities than standard therapy.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The VALOR HEP will employ the Phase II-developed VR software for practice of ADL and IADLs with a commercial VR headset (Meta Quest). Independent at-home sessions will include completion of multiple activities targeting specific gross and fine motor skills. Patients will receive instruction on the VALOR system and HEP protocol during an initial outpatient visit, during which a study therapist will verify the patient's ability to safely and successfully use the system. An additional outpatient visit may be conducted if necessary to achieve proficiency. Participants will then be asked to employ the system for UE practice at home 45 minutes/day, 4 days/week over an 8-week period. Once per week, a study therapist will use a secure web application to remotely review adherence, dosage, and performance; and adjust the treatment plan as needed. Every other week, a study therapist will conduct a synchronous telehealth visit with the patient to verify health status, review progress, and update.
Participants assigned to the UCT group will be followed as they continue to receive their previously prescribed therapy services. These subjects will not receive any treatment services through the study as UCT group participants. Every other week, a study therapist will contact UCT group subjects to verify health status and collect information on other therapy services the patient is receiving. To promote equipoise, patients in the UCT group will be provided free access to the VALOR HEP following completion of the control protocol.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Barron Associates, Inc.
Lead Sponsor
Duke University
Collaborator
Citations
Efficacy of Home-Based Physical Exercise in Stroke Survivors
The lack of significant differences in BBS and MAS scores suggests that home-based rehabilitation may not be more effective than other approaches in improving ...
Effect of exercise-based interventions on stroke rehabilitation
Exercise-based interventions are effective at all stages of stroke recovery, improving physical function, mobility, and participation.
3.
obrienphysicaltherapy.net
obrienphysicaltherapy.net/blog/post-stroke-rehabilitation-outcomes-statistics-on-physical-therapy-effectivenessPost-Stroke Rehabilitation Outcomes: Statistics on Physical ...
Evidence consistently shows that tailored rehabilitation programs can enhance functional outcomes such as balance, gait, and muscle strength.
Effects of a training program based on the Proprioceptive ...
This preliminary study sought to analyze the effects of a training program based on the Proprioceptive Neuromuscular Facilitation (PNF) method on motor recovery
Effectiveness of Rehabilitation Exercise in Improving ...
The purpose of the current study is to examine research investigating the effects of rehabilitation exercise programs in recovery of physical function in ...
Virtual Activities of Living for Occupational Rehabilitation
The VALOR HEP will employ the Phase II-developed VR software for practice of ADL and IADLs with a commercial VR headset (Meta Quest). Independent at-home ...
Virtual Activities of Living for Occupational Rehabilitation
The VALOR HEP will employ the Phase II-developed VR software for practice of ADL and IADLs with a commercial VR headset (Meta Quest).
Virtual Reality Exercises for Stroke Rehabilitation (VALOR ...
... VALOR Home Exercise Program (HEP) will have tolerable side effects & efficacy for patients with Stroke, Alternating Hemiplegia, Stroke ...
Effect of Home-Based Virtual Reality Training on Upper ... - PMC
This review shows that home-based VR training positively affects upper extremity function recovery in patients with stroke, especially in motor control ...
Virtual Activities of Living for Occupational Rehabilitation
The study compares VALOR Home Exercise Program (HEP) to Usual Care Treatment (UCT) in adults with stroke-related UE impairment. Locations. Duke University.
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