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Behavioural Intervention

Exercise + VR for Parkinson's Disease

N/A

Recruiting

Led By Anjali Sivaramakrishnan

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects who have a score of ≤21.5 on the Mini Balance Evaluations Systems Test (miniBESTest)

Diagnosis of idiopathic PD (ages 18-85) in Hoehn and Yahr stages 2-3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post (8 week), follow-up (14 weeks)

Awards & highlights

Study Summary

This trial will assess how exercise and VR can improve balance, posture and brain plasticity in people with Parkinson's disease. Two groups will receive exercise and VR over 8 weeks, with outcomes measured before, after and 6 weeks later.

Who is the study for?

This trial is for people aged 18-85 with Parkinson's Disease in moderate stages (2-3), who can think clearly (score ≥23 on a mental exam) and have some balance issues (score ≤21.5 on a balance test). It's not for those with other neurological conditions, severe heart/lung/bone/joint diseases, uncontrolled diabetes or hypertension, brain surgery for PD, head injuries, seizures/epilepsy, pregnancy, certain medications or skull problems.Check my eligibility

What is being tested?

The study tests if high-intensity endurance exercise followed by VR-based gaming improves balance and brain adaptability in Parkinson's patients compared to just stretching exercises plus VR. Participants are split into two groups randomly and assessed over eight weeks of treatment and six weeks after.See study design

What are the potential side effects?

Potential side effects may include fatigue from the high-intensity exercise; discomfort or motion sickness from VR; muscle soreness from stretching; risk of falls due to balance challenges during activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My balance score is 21.5 or lower.

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I have Parkinson's disease, am between 18-85 years old, and my condition is moderate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post (8 week), follow-up (14 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post (8 week), follow-up (14 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post (8 week), follow-up (14 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Balance

Secondary outcome measures

Brain derived neurotrophic growth factor (BDNF)

Corticomotor excitability

Endurance

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stretching and virtual reality (control)Experimental Treatment2 Interventions

The stretching group will perform stretching exercises and VR-based games 3 times a week for 8 weeks.

Group II: High intensity endurance exercise and virtual reality (experimental)Experimental Treatment2 Interventions

The exercise group will perform high intensity interval exercise and VR-based games 3 times a week for 8 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stretching exercise

2014

Completed Phase 3

~320

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

453 Previous Clinical Trials

91,414 Total Patients Enrolled

National Center for Advancing Translational Sciences (NCATS)NIH

322 Previous Clinical Trials

401,747 Total Patients Enrolled

Anjali SivaramakrishnanPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I be a viable participant in this medical experiment?

"This particular clinical trial has a participant limit of 16 and requires that those accepted have been diagnosed with Parkinson's disease, while being between the ages of 18-85."

Answered by AI

Does the age restriction for this research trial include those below twenty years old?

"According to the criteria for enrollment, only persons aged 18 through 85 are eligible to join this medical trial."

Answered by AI

Is the enrollment phase of this research still taking place?

"At this juncture, the information hosted on clinicaltrials.gov indicates that this trial is not presently enrolling patients. Initially posted in January of 2024 and last updated 14th November 2023, recruitment has currently been suspended for this particular study; however, there are 547 other protocols actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in PD

Anjali Sivaramakrishnan 2024. "Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in PD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06133283.