NCT06224491

Brief Summary

Monitoring of non-motor manifestations of reflex locomotion according to Professor Vojta in laboratory conditions on healthy woman probands.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

January 16, 2024

Last Update Submit

January 24, 2024

Conditions

Keywords

reflex locomotion according to Vojta, stress

Outcome Measures

Primary Outcomes (1)

  • Non-motor responses during tactile stimulation in reflex locomotion according to Vojta

    The Trigno Wireless EMG System Delsys will be used to measure electrical muscle activity. The SP-10 Pocket Spirometer Gima and wireless ECG will be used to measure changes in breathing and circulation. In addition, the DASS-42 and POMS questionnaires will be used.

    10 minutes tactile stimulation

Study Arms (2)

Placebo tactile stimulation

SHAM COMPARATOR

From a standardized starting position for 10 minutes tactile contact in the area outside the description of reflex zones in reflex locomotion according to Vojta.

Other: Reflex locomotion according to Vojta

Reflex locomotion zone stimulation

EXPERIMENTAL

From a standardized starting position tactile stimulation in the area of the zone in reflex locomotion according to Vojta for 10 minutes .

Other: Reflex locomotion according to Vojta

Interventions

Tactile stimulation according to Vojta´s reflex locomotion

Also known as: Placebo tactile stimulation.
Placebo tactile stimulationReflex locomotion zone stimulation

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • These will be healthy adult women. The expected number of participants is 20-30. To participate in the study, participants must agree to participate voluntarily.

You may not qualify if:

  • Contraindications for participation include psychiatric illness, cancer, acute inflammatory diseases, and pregnancy. Persons with signs of acute illness or injury or in recovery from acute illness or injury will not be eligible for testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Education and Sport

Prague, 162 52, Czechia

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zuzana Charvátová, PhD.

    Faculty of Physical Education and Sport Charles University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant is not familiar with the order of the intervention.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: These are healthy adult women. The expected number of participants is 20-30. To participate in the study, participants must agree to participate voluntarily. Contraindications for participation include psychiatric illness, cancer, acute inflammatory diseases, and pregnancy. Persons with signs of acute illness or injury or in recovery from acute illness or injury will not be eligible for testing. Subjects who, like the investigators, are students at FTVS UK will be personally approached and selected by the principal investigators. No email or phone number contacts will be used.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tereza Nováková, PhD., Physiotherapy Deparment, Faculty of Physical Education and Sport

Study Record Dates

First Submitted

January 16, 2024

First Posted

January 25, 2024

Study Start

September 1, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

According to the possibility to share raw anonymised data.

Locations