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

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Neurological impairment such as stroke is a leading cause of adult disability. Traditional rehabilitative therapies can help regain motor function and ameliorate disability. There are increasing community and other facilities offering rehabilitation in the form of conventional, recreational and alternative therapy. However, the implementation of these conventional therapy techniques in individuals with a neurological disorder like stroke is tedious, resource-intensive, and costly, often requiring transportation of patients to specialized facilities. Based on recent evidence suggesting significant benefits of repetitive, task-orientated training, investigators propose to evaluate the feasibility of an alternative therapies such as exergaming-based therapy to improve overall physical function of community-dwelling individuals with neurological impairments, compared to conventional therapeutic rehabilitation. This pilot study aims to systematically obtain data on compliance and efficacy of a randomized controlled trial. The objective of the study is to determine the safety, feasibility, compliance and efficacy of exergaming therapy to improve overall physical function of community-dwelling chronic stroke individuals.

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.

Is exergaming-based therapy safe for stroke rehabilitation?

Exergaming-based therapy, including virtual reality systems, has been shown to be safe for stroke rehabilitation, with studies reporting no serious adverse events like falls, dizziness, or pain during sessions. ^{1 2 3 4 5}

How does the virtual reality-based dance treatment for stroke differ from other treatments?

This treatment is unique because it uses virtual reality and dance-based exergames to enhance rehabilitation, offering an engaging and interactive way to improve motor function and quality of life for stroke survivors. Unlike traditional therapy, it can be used at home and provides additional therapy time, which is often limited in one-on-one sessions. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Virtual reality based dance group for stroke?

Research shows that using virtual reality exergaming as an additional therapy for stroke patients can improve daily activities and upper body function. It is safe and feasible, with studies indicating meaningful improvements in movement quality and physical abilities. ^{1 2 7 8 9}

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. United States pubmed.ncbi.nlm.nih.gov

High Frequency and Intensity Rehabilitation in 641 Subacute Ischemic Stroke Patients. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility, Safety and Efficacy of a Virtual Reality Exergame System to Supplement Upper Extremity Rehabilitation Post-Stroke: A Pilot Randomized Clinical Trial and Proof of Principle. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Personalized 3D exergames for in-home rehabilitation after stroke: a pilot study. [2023]

4. Italy pubmed.ncbi.nlm.nih.gov

Comparison of Kinect2Scratch game-based training and therapist-based training for the improvement of upper extremity functions of patients with chronic stroke: a randomized controlled single-blinded trial. [2020]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Motor rehabilitation of patients in the acute period of stroke using virtual reality technology]. [2021]

6. Switzerland 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. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of Virtual Reality and Exergaming in Improving Balance in Patients With Multiple Sclerosis: A Systematic Review and Meta-Analysis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Dance-based exergaming on postural stability and kinematics in people with chronic stroke - A preliminary study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Game analysis and clinical use of the Xbox-Kinect for stroke rehabilitation. [2019]