Fractal-based Gait Training in Older Adults

September 9, 2026 updated by: Egas Moniz - Cooperativa de Ensino Superior, CRL

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Control
Other: Control
Walking in a treadmill
Experimental: Fractal
Other: Fractal
Walking in a treadmill while synchronizing their steps with fractal external visual cues
Experimental: Isochronous
Other: Isochronous
Walking in a treadmill while synchronizing their steps with isochronous external visual cues

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fractal scaling exponent (α) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal, Isochronous and Control 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).
PRE (baseline), POS (4 weeks after), FUP (8 weeks after)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Corticospinal excitability (CSE) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal, Isochronous and Control 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.
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, Isochronous and Control 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 inhibition of the motor cortex.
PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Intracortical Facilitation (ICF) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal, Isochronous and Control groups.
Time Frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
ICF is a parameter extracted through the application of Transcranial Magnetic Stimulation (TMS). This parameter provides information regarding the level of facilitation of the motor cortex.
PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Ankle, Knee and Hip joints range of motion's changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal, Isochronous and Control groups during a gait cycle
Time Frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Joint range of motion is measured through a motion capture system and quantifies the excursion of the joint during the gait task in degrees (º).
PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Ankle, Knee and Hip joints maximum value changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal, Isochronous and Control groups during a gait cycle
Time Frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Joint maximum value is measured through a motion capture system and quantifies the maximum joint flexion during the gait task in degrees (º). This measure will be used to calculate joint range of motion (outcome 2).
PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Ankle, Knee and Hip joints minimum value changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal, Isochronous and Control groups during a gait cycle
Time Frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Joint minimum value is measured through a motion capture system and quantifies the minimum joint flexion during the gait task in degrees (º). This measure will be used to calculate joint range of motion (outcome 2).
PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Ankle, Knee and Hip joints angles during initial contact changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal, Isochronous and Control groups during a gait cycle
Time Frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Joint angle during initial contact is measured through a motion capture system and quantifies the angle of the respective joint at the moment the heel touches the ground during a gait cycle (heel strike) in degrees (º).
PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Ankle, Knee and Hip joints angles during peak ground reaction force changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal, Isochronous and Control groups during a gait cycle
Time Frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Coefficient of variation (CV) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal, Isochronous and Control groups.
Time Frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
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).
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, Isochronous and Control groups.
Time Frame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
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.
PRE (baseline), POS (4 weeks after), FUP (8 weeks after)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Egas Moniz - Cooperativa de Ensino Superior, CRL

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação para a Ciência e a Tecnologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FRACTRAIN-1378/24

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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