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Light Therapy + Exercise for Parkinson's Disease
N/A
Recruiting
Led By Orla Hares, PT
Research Sponsored by Gaitway Neurophysio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Neurologist-diagnosed Hoehn and Yahr Stages 2-3 (moderate) idiopathic PD
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administered in arms 1 & 2 at baseline and weeks 1 & 4 post treatment. each arm is 12 weeks.
Awards & highlights
Study Summary
This trial studies the effects of light therapy combined with exercise on motor & non-motor symptoms of Parkinson's disease. Participants aged 55-80 will either get real or sham light therapy combined with exercise for 4 weeks.
Who is the study for?
This trial is for individuals aged 55-80 with moderate Parkinson's Disease (stages 2-3), who are already participating in an exercise program. They must be able to visit the PD Wellness & Innovation Centre in Hamilton, Ontario, and can be on anti-Parkinson's medications. Excluded are those with poor English comprehension, unstable health conditions, prior light therapy treatment, or inability to perform required tasks due to a MOCA score of ≤23/30.Check my eligibility
What is being tested?
The study tests if at-home photobiomodulation (light therapy) combined with exercise improves motor skills like balance and gait as well as non-motor symptoms such as cognition and mood in Parkinson's patients. It compares active light therapy against placebo over four weeks, measuring outcomes at the start and after each week.See study design
What are the potential side effects?
Potential side effects from the light therapy devices may include mild skin irritation or discomfort at the site of application. However, since this is a non-invasive treatment, severe side effects are not commonly expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with moderate Parkinson's disease by a neurologist.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ administered in arms 1 & 2 at baseline and weeks 1 & 4 post treatment. each arm is 12 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered in arms 1 & 2 at baseline and weeks 1 & 4 post treatment. each arm is 12 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Timed up-and-go (TUG) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment. (TUG) test
Secondary outcome measures
10-meter walk Test (10MWT) speed and stride to measure change from baseline compared to Endpoints at weeks 1 and 4 Post Treatment
Beck Anxiety Inventory (BAI) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
Beck Depression Inventory (BDI) to measure change form baseline compared to Endpoints at Weeks 1 and 4 post treatment
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Active and Placebo Cross OverExperimental Treatment2 Interventions
After the first arm of the study is completed and the post treatment assessments administered, participants in the Active and Placebo groups will be offered the option to complete 8 weeks of real (active) at-home PBM treatment of the abdomen and head (transcranial), 3 x per week for a total of 24 treatments. Each treatment takes approximately 30 minutes to complete. The devices are then returned. Outcome measurement testing will be conducted at Weeks 1 and 4 weeks after the last treatment.
Group II: Randomized, Placebo Controlled, Double-Blind Clinical Trial Real ( Active) vs. Placebo (Sham)Active Control2 Interventions
The first arm includes the real (active) group (n=30) and the placebo (sham) group (n=30). Both groups will self-administer their at-home photobiomodulation (PBM) therapy with devices that either emit active light energy or emit no light energy, respectively. The 30 minute treatment is completed 3 x per week. The protocol includes abdominal PBM treatment with a hand held infrared device and transcranial PBM treatment with an infrared & red LED helmet. Participants are taught how to administer their own treatment and are provided with weekly follow-up. At the completion of the 24 treatments the devices are returned. Post outcome measurement testing is conducted at baseline and 1 and 4 weeks after the last PBM treatment. An inclusion criteria requires that subjects have been exercising 3 x per week before entering the study and continue the minimum level of exercise throughout the study.
Data from the Real group will be compared with the results from in the Placebo group.
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Who is running the clinical trial?
Gaitway NeurophysioLead Sponsor
Anita Saltmarche, MHScStudy ChairSaltmarche Health & Associates
Orla Hares, PTPrincipal InvestigatorNeuro Physio at Gaitway Neurophysio and Parkinson's Wellness Innovation Centre
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