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

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.

Study Overview

• Status: Recruiting
• Conditions: Age >60
• Intervention / Treatment: Other: Sham 8-weeks photobiomodulation; Device: Photobiomodulation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Sinclair, DSc; Phone Number: 07875651533; Email: jksinclair@lancashire.ac.uk

Study Locations

• United Kingdom
  • Lancashire
    • Preston, Lancashire, United Kingdom, PR4 0PE
      • Recruiting
      • University of Central Lancashire
      • Contact: Jonathan Sinclair, DSc; Phone Number: 07875651533; Email: jksinclair@lancashire.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham photobiomodulation; 8-weeks sham photobiomodulation. The sham device will follow the same protocol but without active light emission.	Other: Sham 8-weeks photobiomodulation; The sham device will follow the same protocol but without active light emission.
Experimental: Photobiomodulation; 8-weeks photobiomodulation Twenty-four-minute photobiomodulation stimulation (twelve minutes at 670 nm followed by twelve minutes at 810 nm). Three times per week for 8-weeks.	Device: Photobiomodulation; 8-weeks photobiomodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
n-1-back (deviation)	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.	Baseline
n-1-back (deviation)	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.	1 hour
n-1-back (deviation)	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.	8-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory	Psychological 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.	Baseline
n-2-back (deviation)	The 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.	Baseline
n-2-back (deviation)	The 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.	1 hour
n-2-back (deviation)	The 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.	8-weeks
n-1-back (post-deviation)	The 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.	Baseline
n-1-back (post-deviation)	The 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.	1 hour
n-1-back (post-deviation)	The 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.	8-weeks
n-2-back (post-deviation)	The 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.	Baseline
n-2-back (post-deviation)	The 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.	1 hour
n-2-back (post-deviation)	The 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.	8-weeks
n-1-back (post-target)	The 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.	Baseline
n-1-back (post-target)	The 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.	1 hour
n-1-back (post-target)	The 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.	8-weeks
n-2-back (post-target)	he 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.	Baseline
n-2-back (post-target)	he 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.	1 hour
n-2-back (post-target)	he 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.	8-weeks
n-1-back (load)	The n-1-back (load) condition measures working memory performance under the cognitive demand of tracking stimuli 1 trial back.	Baseline
n-1-back (load)	The n-1-back (load) condition measures working memory performance under the cognitive demand of tracking stimuli 1 trial back.	1 hour
n-1-back (load)	The n-1-back (load) condition measures working memory performance under the cognitive demand of tracking stimuli 1 trial back.	8-weeks
n-2-back (post-load)	The 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.	Baseline
n-2-back (post-load)	The 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.	1 hour
n-2-back (post-load)	The 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.	8-weeks
Coop-Wonka chart	The 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.	Baseline
Coop-Wonka chart	The 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.	1 hour
Coop-Wonka chart	The 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.	8-weeks
Beck Depression Inventory	Psychological 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.	1 hour
Beck Depression Inventory	Psychological 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.	8-weeks
Pittsburgh Sleep Quality Index	The 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.	Baseline
Pittsburgh Sleep Quality Index	The 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.	1 hour
Pittsburgh Sleep Quality Index	The 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.	8-weeks
State Trait Anxiety Inventory	The 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.	Baseline
State Trait Anxiety Inventory	The 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.	1 hour
State Trait Anxiety Inventory	The 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.	8-weeks
Insomnia Severity Index	The 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.	Baseline
Insomnia Severity Index	The 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.	1 hour
Insomnia Severity Index	The 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.	8-weeks
Epworth Sleepiness Scale	The 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.	Baseline
Epworth Sleepiness Scale	The 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.	1 hour
Epworth Sleepiness Scale	The 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.	8-weeks
Everyday Memory Errors Questionnaire	The 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.	Baseline
Everyday Memory Errors Questionnaire	The 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.	1 hour
Everyday Memory Errors Questionnaire	The 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.	8-weeks
Falls Efficacy	The 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.	Baseline
Falls Efficacy	The 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.	1 hour
Falls Efficacy	The 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.	8-weeks
Anterior-posterior balance	The maximum anterior-posterior displacement of the centre of pressure during a two-minute balance task.	Baseline
Anterior-posterior balance	The maximum anterior-posterior displacement of the centre of pressure during a two-minute balance task.	1 hour
Anterior-posterior balance	The maximum anterior-posterior displacement of the centre of pressure during a two-minute balance task.	8-weeks
Medio-lateral balance	The maximum medio-lateral displacement of the centre of pressure during a two-minute balance task.	Baseline
Medio-lateral balance	The maximum medio-lateral displacement of the centre of pressure during a two-minute balance task.	1 hour
Medio-lateral balance	The maximum medio-lateral displacement of the centre of pressure during a two-minute balance task.	8-weeks

Collaborators and Investigators

• Sponsor: University of Central Lancashire

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 10, 2027

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Laser Therapy; Phototherapy; salicylhydroxamic acid; Low-Level Light Therapy
• Other Study ID Numbers: PMB balance and cognition

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No