NCT07829172

Brief Summary

• This exploratory randomized assessor-blinded study aimed to determine whether a single session of Reflex Locomotion Therapy according to Vojta produces immediate changes in postural control in community-dwelling older adults classified as robust or prefrail. The study focused on stabilometric variables during standing tasks, because demanding balance conditions may reveal subtle postural control changes that are not evident during quiet standing. Participants were randomly allocated to an intervention group receiving standardized Vojta therapy or to a control group receiving an educational session of equivalent duration. Postural control was assessed using force platform stabilometry during five standing conditions: eyes open, eyes closed, tandem stance, right single-leg stance, and left single-leg stance. Assessments were performed at baseline, immediately after the intervention, and 20 minutes after the intervention. Positional, dynamic, spectral and nonlinear center of pressure variables were analyzed to explore acute changes in postural sway magnitude, corrective dynamics, frequency-domain organization, and temporal regularity and complexity of postural control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 14, 2026

Last Update Submit

September 14, 2026

Conditions

Keywords

older adultsVojta TherapyReflex Locomotion TherapyPostural ControlStabilometryCenter of pressureBalanceFall risk

Outcome Measures

Primary Outcomes (1)

  • Change in Root Mean Square (RMS) of Center of Pressure Acceleration During Standing Balance Tasks.

    Root mean square (RMS) of center of pressure acceleration is a time domain measure derived from the acceleration of center of pressure signal recorded by force platform stabilometry during standing. It quantifies the magnitude of center of pressure acceleration asociated with corrective postural adjustments made to maintain balance. Higher values indicate greater corrective accelerations. IT is expressed in cm/s2.

    Baselines, immediately post-intervention, and 20 minutes post-intervention

Secondary Outcomes (5)

  • Change in Mean Center of Pressure Velocity During Standing Balance Tasks.

    Baselines, immediately post-intervention, and 20 minutes post-intervention

  • Change in Positional Center of Pressure Measures (RMS in the Mediolateral and Anteroposterior Directions) During Standing Balance Tasks.

    Baseline, immediately post-intervention, and 20 minutes post-intervention.

  • Change in Spectral Center of Pressure Measures (Mean Power Frequency, Dominant Frequency) During Standing Balance Tasks.

    Baseline, immediately post-intervention, and 20 minutes post-intervention.

  • Change in Nonlinear Center of Pressure Measures During Standing Balance Tasks.

    Baseline, immediately post-intervention, and 20 minutes post-intervention

  • Adverse events and Tolerability during the Experimental Session

    Baseline, immediately post-intervention, and 20 minutes post-intervention.

Study Arms (2)

Vojta Therapy Group

EXPERIMENTAL

Participants assigned to this group received a standardized session of Reflex Locomotion Therapy according to Vojta. The protocol was based on the second phase of reflex rolling and was delivered by a trained physical therapist. The intervention consisted of sustained somatosensory stimulation applied to specific body zones, alternating hemibodies according to the standardized protocol.

Other: Reflex Locomotion Therapy according to Vojta

Educational Control Group

ACTIVE COMPARATOR

Participants assigned to this group received an educational session of equivalent duration focused on health and well-being in later life. They did not receive physical therapy, balance exercises, or specific therapeutic stimulation during the experimental period.

Behavioral: Educational Session

Interventions

A non-pharmacological neurorehabilitation intervention based on sustained somatosensory stimulation applied to specific body zones. In this study, a standardized protocol of the second phase of reflex rolling, was used to explore immediate effects on postural control.

Vojta Therapy Group

An educational session focused on general health and well-being in older adulthood, delivered without physical therapy, balance exercises, or specific therapeutic stimulation.

Educational Control Group

Eligibility Criteria

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

You may qualify if:

  • \- Community-dwelling adults aged 60 years or older
  • Residents of Santiago, Chile.
  • Classified as robust or prefrail according to the FRAIL scale: robust=0 positive criteria; prefrail= 1-2 positive criteria
  • Functional performance compatible with safe standing balance assessment, defined as a Short Physical Performance Battery (SPPB) score of 9-10 points
  • Able to stand independently and safely perform standing balance assessments
  • Sufficient cognitive ability to understand and follow simple instructions, assessed using the abbreviated Mini Mental State Examination with a cut-off score of 13 points or higher
  • Able to provide written informed consent

You may not qualify if:

  • \- Neurological conditions affecting postural stability, such as stroke, Parkinson disease, multiple sclerosis, or other relevant neurological disorders.
  • Musculoskeletal disorders, chronic pain, or lower limb prosthesis affecting mobility or balance assessment
  • Permanent use of assistive devices for standing or walking
  • Vestibular disorders, including vertigo
  • Use of medications with potential effects on balance according to clinical history
  • Any medical condition preventing safe participation in the intervention or stabilometric assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Skills Center, Department ok Kinesiology, Universidad Metropolitana de Ciencias de la Educación

Santiago, Región Metropolitrana, Chile

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the intervention, participants and the treating therapist could not be blinded. The outcomes assessor responsible for stabilometric measurements was blinded to group allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly allocated to one of two parallel groups: an intervention group receiving Reflex Locomotion Therapy according to Vojta or a control group receiving an educational session of equivalent duration.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Department of Kinesiology

Study Record Dates

First Submitted

September 14, 2026

First Posted

September 18, 2026

Study Start

June 23, 2025

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

September 18, 2026

Record last verified: 2026-09

Locations