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Can Photobiomodulation Improve Balance and Cognition in Individuals Over 60: a Pilot Feasibility Placebo Randomized Controlled Trial.

Can Photobiomodulation Improve Balance and Cognition in Individuals Over 60: a Pilot Feasibility Placebo Randomized Controlled Trial.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07260903
Enrollment
60
Registered
2025-12-03
Start date
2025-06-01
Completion date
2027-07-10
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age >60

Brief summary

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.

Interventions

DEVICEPhotobiomodulation

8-weeks photobiomodulation

OTHERSham 8-weeks photobiomodulation

The sham device will follow the same protocol but without active light emission.

Sponsors

University of Central Lancashire
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged from 60-80 years * Ability to complete written questionnaires independently * Able to provide informed consent

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
n-1-back (deviation)BaselineThe 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.

Secondary

MeasureTime frameDescription
n-1-back (post-deviation)BaselineThe n-1-back (post-deviation) task assesses working memory performance on the trial immediately following a deviation from the stimulus presented n-1 trials earlier.
n-2-back (post-deviation)BaselineThe n-2-back (post-deviation) task assesses working memory performance on the trial immediately following a deviation from the stimulus presented n-2 trials earlier.
n-1-back (post-target)BaselineThe n-1-back (post-target) task assesses working memory performance on the trial immediately following a target that matched the stimulus presented n-1 trials earlier.
n-2-back (post-target)Baselinehe n-2-back (post-target) task assesses working memory performance on the trial immediately following a target that matched the stimulus presented n-2 trials earlier.
n-1-back (load)BaselineThe n-1-back (load) condition measures working memory performance under the cognitive demand of tracking stimuli 1 trial back.
n-2-back (post-load)BaselineThe n-2-back (post-load) condition assesses working memory performance on the trial immediately following a high cognitive load in the n-2-back task.
Coop-Wonka chartBaselineThe Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.
Beck Depression InventoryBaselinePsychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.
n-2-back (deviation)BaselineThe n-2-back (deviation) task is a working memory test where participants respond when the current stimulus differs from the one presented n-2 trials earlier.
State Trait Anxiety InventoryBaselineThe state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.
Insomnia Severity IndexBaselineThe Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.
Epworth Sleepiness ScaleBaselineThe Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.
Everyday Memory Errors QuestionnaireBaselineThe Everyday Memory Errors Questionnaire is a brief self-report instrument designed to assess the frequency of memory lapses in daily life. It consists of multiple items that yield a total score reflecting the extent of everyday memory difficulties.
Falls EfficacyBaselineThe Falls Efficacy Scale is a brief self-report instrument designed to assess confidence in performing daily activities without falling. It consists of multiple items that yield a total score reflecting fear of falling and perceived fall-related self-efficacy.
Anterior-posterior balanceBaselineThe maximum anterior-posterior displacement of the centre of pressure during a two-minute balance task.
Medio-lateral balanceBaselineThe maximum medio-lateral displacement of the centre of pressure during a two-minute balance task.
Pittsburgh Sleep Quality IndexBaselineThe Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.

Countries

United Kingdom

Contacts

Primary ContactJonathan Sinclair, DSc
jksinclair@lancashire.ac.uk07875651533

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026