Fractal-based Gait Training in Older Adults

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: Enrolling by invitation
• Conditions: Healthy Aging
• Intervention / Treatment: Other: Fractal; Other: Isochronous; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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.	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

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.	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.	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.	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	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	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	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	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		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.	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.	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

• Sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL
• Collaborators: Fundação para a Ciência e a Tecnologia

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Aging; Neuroscience; Gait Rehabilitation; Falls Prevention; Dynamical Systems
• Additional Relevant MeSH Terms: Investigative Techniques; Mathematical Concepts; Models, Theoretical; Fractals
• Other Study ID 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