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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 below

Select...

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and administered in arms 1 & 2 at baseline and weeks 1 & 4 post treatment. each arm is 12 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

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 more

Trial 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.

0 / 1Eligibility criteria met

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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

Frequently Asked Questions

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

Does the study permit participants who are under two decades of age?

"As per the guidelines of this clinical trial, only those aged 55 to 80 are allowed to participate."

Answered by AI

Is it possible for me to register in this research trial?

"To be eligible for this particular medical trial, patients must have been diagnosed with Parkinson's disease and fall in the age range of 55 to 80 years old. The maximum number of participants accepted is 60 individuals altogether."

Answered by AI

Is there presently an opportunity to join the clinical trial?

"Affirmative. According to clinicaltrials.gov, this ongoing study is currently accepting volunteers with the posting date beginning on January 2nd 2023 and being updated as recently as September 13th 2023. The research has a target of 60 patients from one specified location."

Answered by AI

How many participants are being enrolled in this research endeavor?

"Affirmative, the information hosted on clinicaltrials.gov confirms that this research trial is actively recruiting individuals to take part in it. This project was initially posted on 2nd January 2023 and edited most recently on 13th September 2023. The researchers are hoping for 60 persons from one medical centre to join them in their endeavour."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Light Therapy Plus Exercise to Improve Motor, Non-Motor Symptoms and QoL in Parkinson's Disease

2023. "Light Therapy Plus Exercise to Improve Motor, Non-Motor Symptoms and QoL in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06036433.