Healthy AgingNCT06507137

Fractal-based Gait Training in Older Adults

A study testing Fractal and Isochronous in people with Healthy Aging, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to investigate the influence of walking with external visual cues on brain adaptations. Read more about this study

Who is it for?: Ages 60 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Aging
What is being tested?: Fractal and Isochronous
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 sitePortugal
Study dates: 25 Jun 2024to 31 Jul 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Neurologic conditions;
Lower limb disabilities or disease;
Not able to provide informed consent;
Unable to walk unassisted for 10-minutes continuously;
Score below 24 in the Mini-Mental State Examination (MMSE);
Have a history of falls in the prior six months;
Have an implanted device (e.g., pacemakers);
Medication advised against the application of Transcranial Magnetic Stimulation.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

Egas Moniz School of Health and Science
Almada, Monte de Caparica, 2829-699

Other trials in Portugal

About this study

Official title: Fractal-based Gait Training in Older Adults: Implications to Motor Control and Neuroplasticity

The purpose of the study is to investigate the influence of walking with external visual cues on brain adaptations.

Conditions: Healthy Aging
Being tested: Fractal, Isochronous
Keywords: Gait Rehabilitation, Aging, Neuroscience, Falls Prevention, Dynamical Systems

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FractalOther
Walking in a treadmill while synchronizing their steps with fractal external visual cues
IsochronousOther
Walking in a treadmill while synchronizing their steps with isochronous external visual cues

Study groups in NCT06507137
Study group	Role	What they receive
Fractal	Experimental	Not described Receives: Other: Fractal
Isochronous	Experimental	Not described Receives: Other: Isochronous

What is being measured

The primary outcome is the main question the study is designed to answer.

Fractal scaling exponent (α) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups.
The fractal scaling exponent quantifies the complexity of a physiological signal and detects the presence of statistical persistence in a given time series. This parameter is calculated using Detrended Fluctuation Analysis (DFA) from each time series (stride time and stride length).
Measured: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Cortical silent period (SP) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups.
SP is a parameter extracted through the application of Transcranial Magnetic Stimulation (TMS). This parameter provides information regarding the level of GABA-B-mediated intracortical inhibition of the motor cortex.
Measured: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Short-Interval Intracortical Inhibition (SICI) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups.
SICI is a parameter extracted through the application of Transcranial Magnetic Stimulation (TMS). This parameter provides information regarding the level of GABA-A-mediated intracortical inhibition of the motor cortex.
Measured: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Corticospinal excitability (CSE) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups.
CSE is a parameter extracted through the application of Transcranial Magnetic Stimulation (TMS). This parameter provides information regarding the level of excitability of the corticospinal tract.
Measured: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)

Secondary outcomes (7)

Coefficient of variation (CV) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups.
CV is a common linear measure that translates the amount of variability within the signal and is calculated through the standard deviation normalised to the mean from each time series (stride time and stride length).
Measured: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Tibialis anterior electromyography amplitude changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups. Measures were extracted from the gait cycle, stance phase and swing phase.
Electromyography amplitude reflects the broad activation of the muscle during a task. This parameter It is an important mechanism of the central nervous system to regulate joint stability and provide movement accuracy.
Measured: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Gastrocnemius medialis electromyography amplitude changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups. Measures were extracted from the gait cycle, stance phase and swing phase.
Electromyography amplitude reflects the broad activation of the muscle during a task. This parameter It is an important mechanism of the central nervous system to regulate joint stability and provide movement accuracy.
Measured: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Electromyography co-contraction changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups. Measures were extracted from the gait cycle, stance phase and swing phase.
Co-contraction is the simultaneous activation of the agonist and antagonist muscles during a task. This parameter It is an important mechanism of the central nervous system to regulate joint stability and provide movement accuracy.
Measured: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Preferred walking speed (PWS) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups.
PWS corresponds to the comfortable velocity participants walked to (and its evolution) throughout the intervention.
Measured: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Mean asynchronies (ASYNCmean) throughout the intervention (PRE to POS) both within and between Fractal and Isochronous groups.
ASYNC mean represents the time in ms an individual steps before (-) or after (+) the visual stimuli event.
Measured: PRE (baseline), POS (4 weeks after), FUP (8 weeks after).
Anticipatory stride percentage (ASYNCratio) throughout the intervention (PRE to POS) both within and between Fractal and Isochronous groups.
ASYNCratio represent the amount of strides, in percentage, an individual steps earlier than the visual stimuli.
Measured: PRE (baseline), POS (4 weeks), FUP (8 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jun 202431 Jul 2026

First posted18 Jul 2024
Study start25 Jun 2024
Primary completion31 Jul 2026
Study completion31 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy AgingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06507137
Sponsor's protocol ID: FRACTRAIN-1378/24
Status last verified: Oct 2026
First submitted: 19 Jun 2024
Last updated: 26 Oct 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fractal-based Gait Training in Older Adults: Implications to Motor Control and Neuroplasticity
ClinicalTrials.gov ID: NCT06507137
Acronym / sponsor ID: FRACTRAIN-1378/24
Conditions: Healthy Aging
Keywords: Gait Rehabilitation, Aging, Neuroscience, Falls Prevention, Dynamical Systems
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
Collaborators: Fundação para a Ciência e a Tecnologia
Study start: 25 Jun 2024 (actual)
Primary completion: 31 Jul 2026 (actual)
Study completion: 31 Jul 2026 (actual)
First posted: 18 Jul 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to investigate the influence of walking with external visual cues on brain adaptations.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Fractal	Experimental	Other: Fractal
Isochronous	Experimental	Other: Isochronous

Who may qualify

Ages: 60 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (8 listed)

Neurologic conditions;
Lower limb disabilities or disease;
Not able to provide informed consent;
Unable to walk unassisted for 10-minutes continuously;
Score below 24 in the Mini-Mental State Examination (MMSE);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FractalWalking in a treadmill while synchronizing their steps with fractal external visual cues	Other	Fractal
IsochronousWalking in a treadmill while synchronizing their steps with isochronous external visual cues	Other	Isochronous

Primary outcome

Fractal scaling exponent (α) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups.
Time frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
The fractal scaling exponent quantifies the complexity of a physiological signal and detects the presence of statistical persistence in a given time series. This parameter is calculated using Detrended Fluctuation Analysis (DFA) from each time series (stride time and stride length).
Cortical silent period (SP) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups.
Time frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
SP is a parameter extracted through the application of Transcranial Magnetic Stimulation (TMS). This parameter provides information regarding the level of GABA-B-mediated intracortical inhibition of the motor cortex.
Short-Interval Intracortical Inhibition (SICI) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups.
Time frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
SICI is a parameter extracted through the application of Transcranial Magnetic Stimulation (TMS). This parameter provides information regarding the level of GABA-A-mediated intracortical inhibition of the motor cortex.
Corticospinal excitability (CSE) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups.
Time frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
CSE is a parameter extracted through the application of Transcranial Magnetic Stimulation (TMS). This parameter provides information regarding the level of excitability of the corticospinal tract.

7 secondary outcomes

Coefficient of variation (CV) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups.
Time frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Tibialis anterior electromyography amplitude changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups. Measures were extracted from the gait cycle, stance phase and swing phase.
Time frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Gastrocnemius medialis electromyography amplitude changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups. Measures were extracted from the gait cycle, stance phase and swing phase.
Time frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Electromyography co-contraction changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups. Measures were extracted from the gait cycle, stance phase and swing phase.
Time frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Preferred walking speed (PWS) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups.
Time frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Mean asynchronies (ASYNCmean) throughout the intervention (PRE to POS) both within and between Fractal and Isochronous groups.
Time frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after).
Anticipatory stride percentage (ASYNCratio) throughout the intervention (PRE to POS) both within and between Fractal and Isochronous groups.
Time frame: PRE (baseline), POS (4 weeks), FUP (8 weeks).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Healthy Aging

RecruitingObservational study
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Not yet recruitingObservational study
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Physical Fitness, Aging
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fractal and Isochronous in people with Healthy Aging, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fractal scaling exponent (α) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal and Isochronous groups. (time frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06507137.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.