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NCT Number: NCT07260903

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.

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Key information

Conditions

Age >60

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Lancashire

Preston, Lancashire, PR4 0PE, United Kingdom

Location status: Recruiting

Location contact

Jonathan Sinclair, DSc

CONTACT

[email protected]

07875651533

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photobiomodulation

Device

8-weeks photobiomodulation

Sham 8-weeks photobiomodulation

Other

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

Primary outcomes

  1. n-1-back (deviation)

    Time frame: 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.

  2. n-1-back (deviation)

    Time frame: 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.

  3. n-1-back (deviation)

    Time frame: 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.

Secondary outcomes

  1. n-2-back (deviation)

    Time frame: Baseline

    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.

  2. n-2-back (deviation)

    Time frame: 1 hour

    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.

  3. n-2-back (deviation)

    Time frame: 8-weeks

    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.

  4. n-1-back (post-deviation)

    Time frame: Baseline

    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.

  5. n-1-back (post-deviation)

    Time frame: 1 hour

    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.

  6. n-1-back (post-deviation)

    Time frame: 8-weeks

    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.

  7. n-2-back (post-deviation)

    Time frame: Baseline

    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. n-2-back (post-deviation)

    Time frame: 1 hour

    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.

  9. n-2-back (post-deviation)

    Time frame: 8-weeks

    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.

  10. n-1-back (post-target)

    Time frame: Baseline

    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.

  11. n-1-back (post-target)

    Time frame: 1 hour

    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.

  12. n-1-back (post-target)

    Time frame: 8-weeks

    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.

  13. n-2-back (post-target)

    Time frame: Baseline

    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.

  14. n-2-back (post-target)

    Time frame: 1 hour

    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.

  15. n-2-back (post-target)

    Time frame: 8-weeks

    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.

  16. n-1-back (load)

    Time frame: Baseline

    The n-1-back (load) condition measures working memory performance under the cognitive demand of tracking stimuli 1 trial back.

  17. n-1-back (load)

    Time frame: 1 hour

    The n-1-back (load) condition measures working memory performance under the cognitive demand of tracking stimuli 1 trial back.

  18. n-1-back (load)

    Time frame: 8-weeks

    The n-1-back (load) condition measures working memory performance under the cognitive demand of tracking stimuli 1 trial back.

  19. n-2-back (post-load)

    Time frame: Baseline

    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.

  20. n-2-back (post-load)

    Time frame: 1 hour

    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.

  21. n-2-back (post-load)

    Time frame: 8-weeks

    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.

  22. Coop-Wonka chart

    Time frame: Baseline

    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.

  23. Coop-Wonka chart

    Time frame: 1 hour

    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.

  24. Coop-Wonka chart

    Time frame: 8-weeks

    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.

  25. Beck Depression Inventory

    Time frame: Baseline

    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.

  26. Beck Depression Inventory

    Time frame: 1 hour

    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.

  27. Beck Depression Inventory

    Time frame: 8-weeks

    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.

  28. Pittsburgh Sleep Quality Index

    Time frame: Baseline

    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.

  29. Pittsburgh Sleep Quality Index

    Time frame: 1 hour

    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.

  30. Pittsburgh Sleep Quality Index

    Time frame: 8-weeks

    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.

  31. State Trait Anxiety Inventory

    Time frame: Baseline

    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.

  32. State Trait Anxiety Inventory

    Time frame: 1 hour

    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.

  33. State Trait Anxiety Inventory

    Time frame: 8-weeks

    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.

  34. Insomnia Severity Index

    Time frame: Baseline

    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.

  35. Insomnia Severity Index

    Time frame: 1 hour

    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.

  36. Insomnia Severity Index

    Time frame: 8-weeks

    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.

  37. Epworth Sleepiness Scale

    Time frame: Baseline

    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.

  38. Epworth Sleepiness Scale

    Time frame: 1 hour

    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.

  39. Epworth Sleepiness Scale

    Time frame: 8-weeks

    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.

  40. Everyday Memory Errors Questionnaire

    Time frame: Baseline

    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.

  41. Everyday Memory Errors Questionnaire

    Time frame: 1 hour

    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.

  42. Everyday Memory Errors Questionnaire

    Time frame: 8-weeks

    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.

  43. Falls Efficacy

    Time frame: Baseline

    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.

  44. Falls Efficacy

    Time frame: 1 hour

    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.

  45. Falls Efficacy

    Time frame: 8-weeks

    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.

  46. Anterior-posterior balance

    Time frame: Baseline

    The maximum anterior-posterior displacement of the centre of pressure during a two-minute balance task.

  47. Anterior-posterior balance

    Time frame: 1 hour

    The maximum anterior-posterior displacement of the centre of pressure during a two-minute balance task.

  48. Anterior-posterior balance

    Time frame: 8-weeks

    The maximum anterior-posterior displacement of the centre of pressure during a two-minute balance task.

  49. Medio-lateral balance

    Time frame: Baseline

    The maximum medio-lateral displacement of the centre of pressure during a two-minute balance task.

  50. Medio-lateral balance

    Time frame: 1 hour

    The maximum medio-lateral displacement of the centre of pressure during a two-minute balance task.

  51. Medio-lateral balance

    Time frame: 8-weeks

    The maximum medio-lateral displacement of the centre of pressure during a two-minute balance task.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Sinclair, DSc

CONTACT

[email protected]

07875651533

Sponsors and collaborators

Lead sponsor

University of Central Lancashire

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.