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

NCT ID: NCT07260903

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-07-10

Brief Summary

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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.

Detailed Description

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Conditions

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Age >60

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sham photobiomodulation

8-weeks sham photobiomodulation.

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

Group Type SHAM_COMPARATOR

Sham 8-weeks photobiomodulation

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Photobiomodulation

Intervention Type DEVICE

8-weeks photobiomodulation

Interventions

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Photobiomodulation

8-weeks photobiomodulation

Intervention Type DEVICE

Sham 8-weeks photobiomodulation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Central Lancashire

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Sinclair

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Central Lancashire

Preston, Lancashire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Jonathan Sinclair, DSc

Role: CONTACT

07875651533

Facility Contacts

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Jonathan Sinclair, DSc

Role: primary

07875651533

Other Identifiers

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PMB balance and cognition

Identifier Type: -

Identifier Source: org_study_id

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