Disease Clinical Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | May 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Gaitway Neurophysio and Parkinson's Wellness Innovation Centre | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Gaitway Neurophysio |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Administered in Arm 1 & 2 at baseline and 1 and 4 weeks after treatment has been completed. Each arm is 12 weeks. | |
Secondary | 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. | Administered in Arms 1 & 2 at baseline and at Weeks 1 & 4 post treatment. Each arm is 12 weeks. | |
Secondary | 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. | Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks. | |
Secondary | 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.) | Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks. | |
Secondary | 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. | Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks. | |
Secondary | 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. | Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks. | |
Secondary | 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. | Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks in duration. | |
Secondary | 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. | Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 week. . | |
Secondary | 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. | Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is 12 weeks. | |
Secondary | 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. | Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is 12 weeks. | |
Secondary | 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. | Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is a total of 12 weeks in total. | |
Secondary | 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. | Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is a total of 12 weeks. |
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