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Enrolling by Invitation

NCT Number: NCT06507137

Fractal-based Gait Training in Older Adults

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

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Key information

Conditions

Healthy Aging

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Egas Moniz School of Health and Science

Almada, Monte de Caparica, 2829-699, Portugal

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Fractal

Other

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

Isochronous

Other

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

Control

Other

Walking in a treadmill

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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)

  9. 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).

  10. 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.

Sponsors and collaborators

Lead sponsor

Egas Moniz - Cooperativa de Ensino Superior, CRL

Other

Collaborators

  • Fundação para a Ciência e a Tecnologia

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2024
Registry last updated
Sep 22, 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.

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