Clinical trial NCT06507137: Fractal-based Gait Training in Older Adults
Official title: Fractal-based Gait Training in Older Adults: Implications to Motor Control and Neuroplasticity
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy Aging
Keywords: Gait Rehabilitation
Aging
Neuroscience
Falls Prevention
Dynamical Systems
Lead sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
First posted: 2024-07-18
Enrollment: 66
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Secondary outcomes:
measure: Corticospinal excitability (CSE) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal, Isochronous and Control groups.
timeFrame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
measure: 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.
timeFrame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
measure: Intracortical Facilitation (ICF) changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal, Isochronous and Control groups.
timeFrame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
measure: 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
timeFrame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
measure: 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
timeFrame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
measure: 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
timeFrame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
measure: 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
timeFrame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
measure: 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
timeFrame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
measure: 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.
timeFrame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
measure: Electromyography co-contraction changes from baseline (PRE to POS, PRE to FUP, POS to FUP) both within and between Fractal, Isochronous and Control groups.
timeFrame: PRE (baseline), POS (4 weeks after), FUP (8 weeks after)
Other outcomes:
Locations:
city: Almada
country: Portugal
facility: Egas Moniz School of Health and Science
state: Monte De Caparica
Study officials:
References: