Exergaming-Based Therapy for Stroke

(ABCcare Trial)

Overseen By savitha subramaniam

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Sedatives, Botox

Disqualifiers: Cognitive impairment, Cardiovascular, Pulmonary, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help stroke survivors improve physical function through exergaming, a fun, video game-based exercise. Participants will either join a virtual reality-based dance group or continue with standard exercises and fall prevention education. The researchers aim to determine if virtual dance sessions are as safe and effective as traditional therapy. The trial seeks individuals who have had a stroke for at least six months, can stand and walk, and are comfortable using English. As an unphased study, this trial provides a unique opportunity to explore innovative rehabilitation methods that could enhance recovery and quality of life.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on sedative drugs or participating in other treatments like Botox, you may not be eligible to participate.

What prior data suggests that exergaming-based therapy is safe for individuals with neurological impairments?

Research has shown that virtual reality (VR) exercise games, such as the dance training in this trial, are generally safe for stroke recovery. One study found that most participants adhered to the therapy, with any unexpected problems being mild and rare. Another study demonstrated that VR-supported exercise improves movement in stroke patients, confirming its safety. Thus, previous research has shown the VR dance therapy being tested to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the virtual reality-based dance therapy for stroke rehabilitation because it offers a unique, engaging approach that differs from traditional exercises. Standard stroke rehabilitation typically involves conventional physical exercises and fall prevention programs, which can be monotonous. In contrast, this treatment uses a popular dance video game, "Just Dance 3," incorporating both slow and fast-paced dances, making the therapy more enjoyable and potentially increasing patient motivation and adherence. Additionally, the therapy transitions from in-lab sessions to telerehabilitation at home, providing flexibility and convenience that isn't typically available with standard care. This innovative approach not only aims to enhance physical recovery but also promotes an interactive and fun way for patients to regain mobility.

What evidence suggests that exergaming-based therapy is effective for stroke rehabilitation?

This trial will compare virtual reality-based dance therapy with standard care for stroke rehabilitation. Research has shown that virtual reality dance therapy can aid stroke recovery. Studies have found improvements in arm movement and overall motor skills through this therapy. In one study, stroke survivors learned new movements with their affected arm, demonstrating progress in specific tasks. Another study found that virtual reality exercises aided upper limb recovery and improved physical functions. These findings suggest that virtual reality dance can be a promising tool in stroke rehabilitation to help regain physical abilities. ^{2 3 4 6 7}

Who Is on the Research Team?

Savitha Subramaniam

Principal Investigator

uic

Are You a Good Fit for This Trial?

This trial is for adults aged 45-90 who've had a stroke at least 6 months ago, can follow English instructions, and have enough cognitive function to participate. They must be able to stand and walk with or without help but not have severe heart disease, uncontrolled conditions like pain or hypertension, recent fractures or surgeries, infections, other ongoing treatments for stroke or participation in research studies.

Inclusion Criteria

I have had a stroke confirmed by my doctor at least 6 months ago.

My cognitive skills are sufficient for participation.

I can move my arms somewhat after my stroke.

Exclusion Criteria

Your bone density is lower than a certain level as measured by a heel ultrasound machine.

Your blood pressure is too high and not well controlled.

You have trouble remembering things or communicating, as shown by specific test scores.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 6 weeks of exergaming or conventional balance training in a laboratory setting, followed by 4 weeks of telerehabilitation at home.

10 weeks

5 sessions/week for 6 weeks, 3 sessions/week for 2 weeks, 2 sessions/week for 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of physical and cardiovascular health.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual reality based dance group

Trial Overview The study compares the effects of virtual reality-based dance therapy (exergaming) against conventional control activities on physical and cardiovascular health in people living with chronic stroke. It aims to assess how safe and effective this alternative therapy is when done at home.

How Is the Trial Designed?

Group I: Virtual reality based dance group Experimental Treatment 1 Intervention

Virtual-reality based dance training - Participants received Virtual-reality based dance training for 10 weeks using the commercially available Kinect dance game (Microsoft Inc., Redmond, WA, U.S.A.) "Just Dance 3". The first six week session consisted of 5 sessions/week, next two weeks of 3 sessions/week and last two weeks of 2 sessions/week, for a total of 20 sessions. Participants played on 10 songs for the first 2 weeks, progressing to 12 songs during the 3nd and 4th weeks with an addition of 2 more songs of their choice during the last two weeks. Participants played on alternating slow- and fast-paced songs (each maximum of 4 minutes in duration) with a five minutes break after a set of one slow and fast song. The first 6 weeks are conducted in the laboratory. The next four weeks are conducted in the participants home via telerehabilitation. The four week sessions consisted of 3 sessions/week.

Group II: Control Active Control 2 Interventions

Participants in the control group will receive current standard of care: education on conventional exercise and fall prevention programs. The control and intervention groups will have the same duration of 10 weeks (1session/week), while the format of the contact (Tele) and session time of the contact will be proportional to the content delivered (30-45 minutes/session) in the control group; 80-90 minutes in the intervention group). Participants, regardless of randomization, will complete assessments and follow-ups with blinded outcome assessors.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

The Personalized In-home eXErgames for Rehabilitation (PIXER) system is a novel 3D exergame platform that allows stroke survivors to engage in home exercise programs, showing feasibility for community-dwelling patients after stroke.

In a clinical pilot study with 10 stroke survivors over 1 month, participants demonstrated positive trends in physical functioning, with 70% completing the program and improvements noted in the Stroke Impact Scale scores, suggesting potential benefits for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized 3D exergames for in-home rehabilitation after stroke: a pilot study. Desai, K., Prabhakaran, B., Ifejika, N., et al.[2023]

In a study of 60 patients recovering from ischemic stroke, the use of virtual reality rehabilitation significantly improved motor function in the lower extremities compared to standard rehabilitation methods, with notable improvements in NIHSS and RMI scores.

The virtual reality intervention, which involved stimulating the plantar surface and using animated movement demonstrations, showed that patients were more ready to achieve independent walking after 10 days of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Motor rehabilitation of patients in the acute period of stroke using virtual reality technology]. Zakharov, AV., Khivintseva, EV., Chaplygin, SS., et al.[2021]

In a pilot study involving 20 stroke patients aged 33-65, both conventional balance training and multi-exergaming showed significant improvements in functional balance, with the exergaming group demonstrating particularly notable enhancements in specific tests like the Four Square Step Test and the 10 Meter Walk Test.

While both training methods were effective, the exergaming approach allowed for targeted motor control training and may offer a feasible option for independent balance training, which could be beneficial for home rehabilitation, despite the study's low statistical power.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-Exergames to Set Targets and Supplement the Intensified Conventional Balance Training in Patients With Stroke: A Randomized Pilot Trial. Cikajlo, I., Rudolf, M., Mainetti, R., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12565396/

Virtual Reality Exergaming in Outpatient Stroke Rehabilitation This scoping review aims to map and synthesize peer-reviewed experimental evidence on virtual reality exergaming for functional rehabilitation ...

2. jmir.org jmir.org/2022/6/e24111/

Effectiveness of Using Virtual Reality–Supported Exercise ... This study examined the effectiveness of using VR-supported exercise therapy for upper extremity motor rehabilitation in patients with stroke.

3. jhandtherapy.org jhandtherapy.org/article/S0894-1130(16)30022-9/fulltext

Virtual Reality-Based Dance Gaming Improves ... The purpose of this study was to examine the feasibility and quantify the effect of virtual reality based dance training on the paretic upper extremity ...

4. researchgate.net researchgate.net/publication/303798007_Virtual_Reality-Based_Dance_Gaming_Improves_Performance_on_an_Instrumented_Functional_Arm_Reach_Task_in_Community-Dwelling_Chronic_Stroke_Survivors

Virtual Reality-Based Dance Gaming Improves ... Conclusions: Stroke survivors can learn a movement sequence with their paretic arm, but demonstrate impairments in sequence specific learning.

5. sciencedirect.com sciencedirect.com/science/article/pii/S174438812200130X

Feasibility, acceptability and effects of dance therapy in ... This systematic review aims to examine the feasibility, acceptability and effects of DT in stroke rehabilitation, specifically on functional gains of gait and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5094257/

Does Virtual Reality-based Kinect Dance Training Paradigm ... The current study is the first to assess the effect of a virtual reality-based aerobic dance training paradigm on HRV among individuals with chronic stroke.

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0093318

Virtual Reality Therapy for Adults Post-Stroke: A Systematic ... VR rehabilitation moderately improves outcomes compared to conventional therapy in adults post-stroke. Current CG interventions have been ...