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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Timed up-and-go (TUG) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment. (TUG) test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are unaware of which device they are receiving. The outcomes assessor is unaware of subject randomization and is not involved with any teaching or follow-up of the participants.
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Timed up-and-go (TUG) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment. (TUG) test
时间窗: 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.
次要结局
- 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(Administered in Arms 1 & 2 at baseline and at 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(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(Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 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(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(Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is a total of 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(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.(Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks in duration.)
- Smell test to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment(Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is 12 weeks.)
- Spiral Test to measure fine motor change from baseline compared with Weeks 1 & 4 post treatment.(Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.)
- Parkinson's Disease Quality of Life 39 (PDQ39) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment(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(Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is 12 weeks.)