Can Photobiomodulation Improve Balance and Cognition in Individuals Over 60: a Pilot Feasibility Placebo Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- n-1-back (deviation)
研究概览
简要总结
As people age, changes in balance and memory can make daily life more difficult and increase the risk of falls. Falls are one of the main causes of injury, hospitalization and loss of independence in older adults, while even mild declines in memory and concentration can reduce confidence, social participation and overall quality of life. Therefore, safe, affordable, and practical ways to help older adults remain steady on their feet and mentally sharp are urgently needed.
The aim of this project is therefore to conduct a pilot feasibility randomized controlled trial to examine whether regular home-based photobiomodulation can improve balance and cognitive function in adults aged over 60. If successful, this research could help shape future strategies for preventing falls, enhancing wellbeing and maintaining independence in older people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged from 60-80 years
- •Ability to complete written questionnaires independently
- •Able to provide informed consent
排除标准
- •Current or past history of head injury
- •Use of medications acting on the central nervous system
- •Active skin conditions on the forehead or scalp
- •Ongoing brain stimulation therapy
- •History of migraines
- •Sensitive skin, allergies
结局指标
主要结局
n-1-back (deviation)
时间窗: Baseline
The n-1-back (deviation) task is a working memory test where participants respond when the current stimulus differs from the one presented n-1 trials earlier.
n-1-back (deviation)
时间窗: 1 hour
The n-1-back (deviation) task is a working memory test where participants respond when the current stimulus differs from the one presented n-1 trials earlier.
n-1-back (deviation)
时间窗: 8-weeks
The n-1-back (deviation) task is a working memory test where participants respond when the current stimulus differs from the one presented n-1 trials earlier.
次要结局
- n-2-back (deviation)(Baseline)
- n-2-back (deviation)(1 hour)
- n-1-back (post-deviation)(Baseline)
- n-1-back (post-deviation)(1 hour)
- n-2-back (post-deviation)(Baseline)
- n-2-back (post-deviation)(1 hour)
- n-1-back (post-target)(Baseline)
- n-1-back (post-target)(1 hour)
- n-2-back (post-target)(Baseline)
- n-2-back (post-target)(1 hour)
- n-1-back (load)(Baseline)
- n-1-back (load)(1 hour)
- n-2-back (post-load)(Baseline)
- n-2-back (post-load)(1 hour)
- Coop-Wonka chart(Baseline)
- Coop-Wonka chart(1 hour)
- Beck Depression Inventory(Baseline)
- Beck Depression Inventory(1 hour)
- Pittsburgh Sleep Quality Index(Baseline)
- Pittsburgh Sleep Quality Index(1 hour)
- State Trait Anxiety Inventory(Baseline)
- State Trait Anxiety Inventory(1 hour)
- Insomnia Severity Index(Baseline)
- Insomnia Severity Index(1 hour)
- Epworth Sleepiness Scale(Baseline)
- Epworth Sleepiness Scale(1 hour)
- Everyday Memory Errors Questionnaire(Baseline)
- Everyday Memory Errors Questionnaire(1 hour)
- Falls Efficacy(Baseline)
- Falls Efficacy(1 hour)
- Anterior-posterior balance(Baseline)
- Anterior-posterior balance(1 hour)
- Medio-lateral balance(Baseline)
- Medio-lateral balance(1 hour)
- n-2-back (deviation)(8-weeks)
- n-1-back (post-deviation)(8-weeks)
- n-2-back (post-deviation)(8-weeks)
- n-1-back (post-target)(8-weeks)
- n-2-back (post-target)(8-weeks)
- n-1-back (load)(8-weeks)
- Beck Depression Inventory(8-weeks)
- n-2-back (post-load)(8-weeks)
- Pittsburgh Sleep Quality Index(8-weeks)
- Coop-Wonka chart(8-weeks)
- State Trait Anxiety Inventory(8-weeks)
- Insomnia Severity Index(8-weeks)
- Epworth Sleepiness Scale(8-weeks)
- Everyday Memory Errors Questionnaire(8-weeks)
- Falls Efficacy(8-weeks)
- Anterior-posterior balance(8-weeks)
- Medio-lateral balance(8-weeks)
研究者
Jonathan Sinclair
Professor
University of Central Lancashire