NCT06507137

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jun 2024Dec 2026

First Submitted

Initial submission to the registry

June 19, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

June 25, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

June 19, 2024

Last Update Submit

September 16, 2025

Conditions

Healthy Aging

Keywords

Gait RehabilitationAgingNeuroscienceFalls PreventionDynamical Systems

Outcome Measures

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.

    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 Outcomes (10)

  • Corticospinal excitability (CSE) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal, Isochronous and Control groups.

    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.

    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.

    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

    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

    PRE (baseline), POS (4 weeks after), FUP (8 weeks after)

  • +5 more secondary outcomes

Study Arms (3)

Fractal

EXPERIMENTAL
Other: Fractal

Isochronous

EXPERIMENTAL
Other: Isochronous

Control

EXPERIMENTAL
Other: Control

Interventions

FractalOTHER

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

Fractal
IsochronousOTHER

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

Isochronous
ControlOTHER

Walking in a treadmill

Control

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egas Moniz School of Health and Science

Almada, Monte de Caparica, 2829-699, Portugal

Location

MeSH Terms

Interventions

Fractals

Intervention Hierarchy (Ancestors)

Models, TheoreticalInvestigative TechniquesMathematical Concepts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2024

First Posted

July 18, 2024

Study Start

June 25, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)