Parkinson'sNCT06036433
Light Therapy Plus Exercise to Improve Motor, Non-Motor Symptoms and QoL in Parkinson's Disease
A study testing Infrared laser photobiomodulation device and Infrared & Red LED photobiomodulation device in people with Parkinson's and Disease, run by Gaitway Neurophysio at 1 site in Canada.
Trial summary
Parkinson's disease (PD) is a lifelong and progressive disease and is the second most common progressive neurodegenerative disease worldwide. This study will examine whether there are significant differences in motor (e.g., balance and gait) and non-motor (e.g., cognition, mood, smell \& sleep ) symptoms and quality… Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Parkinson's, Disease
- What is being tested?
- Infrared laser photobiomodulation device and Infrared & Red LED photobiomodulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2023to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neurologist-diagnosed Hoehn and Yahr Stages 2-3 (moderate) idiopathic PD;
- With or without anti-Parkinson's Disease medications;
- Able to attend the PD Wellness \& Innovation Centre in Hamilton, Ontario, Canada,
- Participating in exercise program prior to enrolment
Who cannot join
- Previous PBM treatment
- MOCA score of ≤23/30
- Insufficient understanding of English to sign an informed consent, understand teaching and to perform at-home PBM treatment
- Physically unable to perform tasks required for outcome measurement testing
- History of significant unstable musculoskeletal or neurological disorders or unstable cardiac condition
Trial locations and contacts
1 site in 1 country.
Orla Hares, PT contact
Canada1 site, 1 recruiting
- Recruiting
Gaitway Neurophysio and Parkinson's Wellness Innovation Centre
Hamilton, Ontario, L8P 2B6
Orla Co-Principal Investigator, Reg. PT, 1-905-974-9892, orla@gailwayneurophysio.com
Orla Hare, PT, 1-905-974-9892, research@gaitwayneurophysio.com
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effectiveness of Photobiomodulation With Exercise, to Enhance Motor, Cognition and the Quality of Life of Those With Parkinson's Disease
Parkinson's disease (PD) is a lifelong and progressive disease and is the second most common progressive neurodegenerative disease worldwide.
This study will examine whether there are significant differences in motor (e.g., balance and gait) and non-motor (e.g., cognition, mood, smell \& sleep ) symptoms and quality of life between the Real (active) at-home photobiomodulation (light therapy) combined with exercise group and the Placebo (sham) at-home photobiomodulation (light therapy) combined with exercise group. Each group (Real \& Placebo) will include 30 participants; with moderate PD, ages 55-80. Three outcome measurement sessions will be conducted; at the study entry and the end of Weeks 1 \& 4 after the last light therapy treatment. Exercise must have been part of the participant's routine before entering the study and will continue during and after the light therapy treatments have been completed.
Read the detailed description
Parkinson's disease (PD) is a lifelong and progressive disease; symptoms slowly worsen over time. PD worldwide is the second most common progressive neurodegenerative disease after Alzheimer's disease. To date there is no cure and few long term effective treatment options.
This research study will use two photobiomodulation (light therapy) devices for at-home treatment by the participant using near-infrared (NIR) and visible red photobiomodulation (PBM). Eligible individuals include those with moderate stage PD and between 55-80 years old. The Real (Active) Group (n=30) will be compared with the Placebo (Sham) group (n=30) to determine whether there are significant differences in motor, cognition and QoL. Exercise will have been part of the subject's routine before entering the study and will continue after the PBM treatments have been completed.
PBM treatments include abdominal and transcranial applications. We believe this is the first combined PBM treatment protocol being used in Canada. Placebo and Real PBM devices look and function the same. The treatment protocol used in this trial is similar to recent Australian PD research using a combination of laser and light-emitting diode (LED) treatments. For almost 20 years, similar transcranial LED parameters have been used safely and effectively to treat traumatic brain injury (TBI), aphasia post stroke and Alzheimer's disease and other dementias.
- Conditions
- Parkinson's, Disease
- Being tested
- Infrared laser photobiomodulation device, Infrared & Red LED photobiomodulation device
- Keywords
- Photobiomodulation, Light, Laser, Therapy, Transcranial, Abdominal, Neurologic, Neurodegenerative
- Medical subject headings
- Parkinson Disease, Disease, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared laser photobiomodulation deviceDevice
Also called PDCare Laser by Symbyx Biome Therapies
904 super pulsed Infrared laser PBM therapy for the treatment of the signs and symptoms associated with Parkinson's, such as improved motor, non-motor and Quality of Life.
Infrared & Red LED photobiomodulation deviceDevice
Also called PDNeuro v2.0 by Symbyx
Infrared \& red LED therapy for the treatment of the signs and symptoms associated with Parkinson's, such as motor, non-motor and Quality of Life.
| Study group | Role | What they receive |
|---|---|---|
| Randomized, Placebo Controlled, Double-Blind Clinical Trial Real ( Active) vs. Placebo (Sham) | Active comparator | 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. Receives: Device: Infrared laser photobiomodulation device; Device: Infrared & Red LED photobiomodulation device |
| Active and Placebo Cross Over | Other | 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. Receives: Device: Infrared laser photobiomodulation device; Device: Infrared & Red LED photobiomodulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up-and-go (TUG) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment. (TUG) test
Time taken to stand from a chair, walk 3m, turn around at a marker, return and sit down. Lower time is a better outcome.
Measured: Administered in Arm 1 & 2 at baseline and 1 and 4 weeks after treatment has been completed. Each arm is 12 weeks.
Secondary outcomes (11)
Parts I-VI of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS UPDRS) - to measure change from baseline compared to Endpoints at 1 and 4 weeks Post Treatment
Part I) Mentation, Behavior, and Mood, scored in time, range 0-16, lower score is a better outcome; II) ADL score is 0-52, lower score is better outcome: III) Motor portion, score 0-108, lower score is better outcome; IV) Complications of Therapy (in the past week), scores from 0-23, lower is better outcome; V) Modified Hoehn and Yahr Scale, score from 1-5, lower score is better outcome and VI) Schwab and England ADL scale is scored as a percentage, a lower percentage is a better outcome.
Measured: Administered in Arms 1 & 2 at baseline and at Weeks 1 & 4 post treatment. Each arm is 12 weeks.
10-meter walk Test (10MWT) speed and stride to measure change from baseline compared to Endpoints at weeks 1 and 4 Post Treatment
assessment of gait, scored by timing completion and counting steps, lower scores are a better outcome.
Measured: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
Montreal Cognitive Assessment (MoCA) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
assessment of cognitive abilities, scored 0-30 (higher scores are better.)
Measured: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
Nine-hole peg test (NHPT) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
test for fine motor skills, timing both the dominant and non-dominant hands. Faster times are a better outcome.
Measured: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
Spiral Test to measure fine motor change from baseline compared with Weeks 1 & 4 post treatment.
Spiral drawing is a skilled and complex coordinated motor activity. Scores are based on time and accuracy, a lower scores is a better outcome.
Measured: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
Writing Test to measure fine motor changes from baseline compared to Weeks 1 & 4 post treatment.
Writing test is administered to assess for bradykinesia, micrographia and tremor in Parkinson's disease. Size and quality of writing determine outcome or change.
Measured: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks in duration.
Parkinson's Disease Quality of Life 39 (PDQ39) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
Quality of Life, scored in percentage (0-100%), lower score is a better outcome.
Measured: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 week. .
Parkinson's Disease Sleep Scale ( PDSS) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
self-rate and quantify the level of sleep disruption, 0-60, lower score is a better outcome.
Measured: Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is 12 weeks.
Smell test to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
Investigator administers 4 scents to evaluate the sense of smell, scored between 0-12; higher score is a better outcome.
Measured: Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is 12 weeks.
Beck Depression Inventory (BDI) to measure change form baseline compared to Endpoints at Weeks 1 and 4 post treatment
is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression; lower score is a better outcome.
Measured: Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is a total of 12 weeks in total.
Beck Anxiety Inventory (BAI) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
is a 21-question multiple-choice self-report inventory used to measure how the subject has been feeling in the last week, focusing primarily on somatic symptoms; lower score is a better outcome.
Measured: Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is a total of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start2 Jan 2023
- Primary completionJan 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson'sStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- There are two study arms; the first is a randomized, controlled, double-blind design with Real (Active) and Placebo groups. The study will evaluate the effect of light therapy (photobiomodulation - PBM) on treating the symptoms of moderate-stage PD. Regular exercise is a study prerequisite and must continue throughout the study. There are 30 per group, ages 55-80. Both groups will complete 30-minute, at-home PBM treatments, 3 days/week x 8 weeks (total of 24). Then devices are returned. Subjects have outcome measurement testing at Entry and the end of Weeks 1 \& 4 after the last PBM treatment. The Crossover includes both the Active \& Placebo groups interested in participating in the same 8-week at-home Real PBM protocol outlined above. The same education and weekly support in the first arm is provided in the second arm of the study. Then the devices are returned. Outcome measurement testing will be conducted 1 and 4 weeks after the last PBM treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaitway Neurophysio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita Saltmarche, MHSc, Study chair, Saltmarche Health & AssociatesOrla Hares, PT, Principal investigator, Neuro Physio at Gaitway Neurophysio and Parkinson's Wellness Innovation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036433
- Sponsor's protocol ID
- PBM&exerciseforPDCanada
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2022
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effectiveness of Photobiomodulation With Exercise, to Enhance Motor, Cognition and the Quality of Life of Those With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06036433
- Acronym / sponsor ID
- PBM&exerciseforPDCanada
- Conditions
- Parkinson's, Disease
- Keywords
- Photobiomodulation, Light, Laser, Therapy, Transcranial, Abdominal, Neurologic, Neurodegenerative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gaitway NeurophysioUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parkinson's disease (PD) is a lifelong and progressive disease and is the second most common progressive neurodegenerative disease worldwide.
This study will examine whether there are significant differences in motor (e.g., balance and gait) and non-motor (e.g., cognition, mood, smell \& sleep ) symptoms and quality of life between the Real (active) at-home photobiomodulation (light therapy) combined with exercise group and the Placebo (sham) at-home photobiomodulation (light therapy) combined with exercise group. Each group (Real \& Placebo) will include 30 participants; with moderate PD, ages 55-80. Three outcome measurement sessions will be conducted; at the study entry and the end of Weeks 1 \& 4 after the last light therapy treatment. Exercise must have been part of the participant's routine before entering the study and will continue during and after the light therapy treatments have been completed.
Detailed description
Parkinson's disease (PD) is a lifelong and progressive disease; symptoms slowly worsen over time. PD worldwide is the second most common progressive neurodegenerative disease after Alzheimer's disease. To date there is no cure and few long term effective treatment options.
This research study will use two photobiomodulation (light therapy) devices for at-home treatment by the participant using near-infrared (NIR) and visible red photobiomodulation (PBM). Eligible individuals include those with moderate stage PD and between 55-80 years old. The Real (Active) Group (n=30) will be compared with the Placebo (Sham) group (n=30) to determine whether there are significant differences in motor, cognition and QoL. Exercise will have been part of the subject's routine before entering the study and will continue after the PBM treatments have been completed.
PBM treatments include abdominal and transcranial applications. We believe this is the first combined PBM treatment protocol being used in Canada. Placebo and Real PBM devices look and function the same. The treatment protocol used in this trial is similar to recent Australian PD research using a combination of laser and light-emitting diode (LED) treatments. For almost 20 years, similar transcranial LED parameters have been used safely and effectively to treat traumatic brain injury (TBI), aphasia post stroke and Alzheimer's disease and other dementias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two study arms; the first is a randomized, controlled, double-blind design with Real (Active) and Placebo groups. The study will evaluate the effect of light therapy (photobiomodulation - PBM) on treating the symptoms of moderate-stage PD. Regular exercise is a study prerequisite and must continue throughout the study. There are 30 per group, ages 55-80. Both groups will complete 30-minute, at-home PBM treatments, 3 days/week x 8 weeks (total of 24). Then devices are returned. Subjects have outcome measurement testing at Entry and the end of Weeks 1 \& 4 after the last PBM treatment. The Crossover includes both the Active \& Placebo groups interested in participating in the same 8-week at-home Real PBM protocol outlined above. The same education and weekly support in the first arm is provided in the second arm of the study. Then the devices are returned. Outcome measurement testing will be conducted 1 and 4 weeks after the last PBM treatment.
| Arm | Type | Receives |
|---|---|---|
| Randomized, Placebo Controlled, Double-Blind Clinical Trial Real ( Active) vs. Placebo (Sham) | Active comparator | Device: Infrared laser photobiomodulation device, Device: Infrared & Red LED photobiomodulation deviceThe 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. |
| Active and Placebo Cross Over | Other | Device: Infrared laser photobiomodulation device, Device: Infrared & Red LED photobiomodulation deviceAfter 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Neurologist-diagnosed Hoehn and Yahr Stages 2-3 (moderate) idiopathic PD;
- With or without anti-Parkinson's Disease medications;
- Able to attend the PD Wellness \& Innovation Centre in Hamilton, Ontario, Canada,
- Participating in exercise program prior to enrolment
Key exclusion criteria (5 listed)
- Previous PBM treatment
- MOCA score of ≤23/30
- Insufficient understanding of English to sign an informed consent, understand teaching and to perform at-home PBM treatment
- Physically unable to perform tasks required for outcome measurement testing
- History of significant unstable musculoskeletal or neurological disorders or unstable cardiac condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared laser photobiomodulation deviceAlso: PDCare Laser by Symbyx Biome Therapies904 super pulsed Infrared laser PBM therapy for the treatment of the signs and symptoms associated with Parkinson's, such as improved motor, non-motor and Quality of Life. | Device | Active and Placebo Cross Over, Randomized, Placebo Controlled, Double-Blind Clinical Trial Real ( Active) vs. Placebo (Sham) |
| Infrared & Red LED photobiomodulation deviceAlso: PDNeuro v2.0 by SymbyxInfrared \& red LED therapy for the treatment of the signs and symptoms associated with Parkinson's, such as motor, non-motor and Quality of Life. | Device | Active and Placebo Cross Over, Randomized, Placebo Controlled, Double-Blind Clinical Trial Real ( Active) vs. Placebo (Sham) |
Primary outcome
Timed up-and-go (TUG) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment. (TUG) test
Time frame: Administered in Arm 1 & 2 at baseline and 1 and 4 weeks after treatment has been completed. Each arm is 12 weeks.
Time taken to stand from a chair, walk 3m, turn around at a marker, return and sit down. Lower time is a better outcome.
11 secondary outcomes
Parts I-VI of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS UPDRS) - to measure change from baseline compared to Endpoints at 1 and 4 weeks Post Treatment
Time frame: Administered in Arms 1 & 2 at baseline and at Weeks 1 & 4 post treatment. Each arm is 12 weeks.
10-meter walk Test (10MWT) speed and stride to measure change from baseline compared to Endpoints at weeks 1 and 4 Post Treatment
Time frame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
Montreal Cognitive Assessment (MoCA) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
Time frame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
Nine-hole peg test (NHPT) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
Time frame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
Spiral Test to measure fine motor change from baseline compared with Weeks 1 & 4 post treatment.
Time frame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
Writing Test to measure fine motor changes from baseline compared to Weeks 1 & 4 post treatment.
Time frame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks in duration.
Parkinson's Disease Quality of Life 39 (PDQ39) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
Time frame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 week. .
Parkinson's Disease Sleep Scale ( PDSS) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
Time frame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is 12 weeks.
Smell test to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
Time frame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is 12 weeks.
Beck Depression Inventory (BDI) to measure change form baseline compared to Endpoints at Weeks 1 and 4 post treatment
Time frame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is a total of 12 weeks in total.
Beck Anxiety Inventory (BAI) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
Time frame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is a total of 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Study is being conducted at Parkinson's Wellness \& Innovation CentreLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orla Hares, PT contact
Anita Saltmarche, MHSc study chair
Saltmarche Health & Associates
Orla Hares, PT principal investigator
Neuro Physio at Gaitway Neurophysio and Parkinson's Wellness Innovation Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrared laser photobiomodulation device and Infrared & Red LED photobiomodulation device in people with Parkinson's and Disease, run by Gaitway Neurophysio at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orla Hares, PT (1-906-974-9892, research@gaitwayneurophysio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed up-and-go (TUG) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment. (TUG) test (time frame: Administered in Arm 1 & 2 at baseline and 1 and 4 weeks after treatment has been completed. Each arm is 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.