Postural BalanceVOJTABALANCENCT07829172
Immediate Effects of Vojta Therapy on Postural Control in Older Adults
A study testing Reflex Locomotion Therapy according to Vojta and Educational Session in people with Postural Balance and Aging, run by Marianela Alejandra Valenzuela Sandoval at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postural Balance, Aging, Frailty
- What is being tested?
- Reflex Locomotion Therapy according to Vojta and Educational Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChile
- Study dates
- 23 Jun 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
Chile1 site
Clinical Skills Center, Department ok Kinesiology, Universidad Metropolitana de Ciencias de la Educación
Santiago, Región Metropolitrana
About this study
Official title: Immediate Effects of Reflex Locomotion Therapy According to Vojta on Postural Control Task in Older Adults: An Exploratory Randomized Assessor-Blinded Study
- 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.
Read the detailed description
Falls and balance impairments are major health concerns in older adults because they are associated with functional decline, loss of independence, fear of falling, and increased healthcare burden. Postural control is a key modifiable factor related to fall risk. Subtle changes in postural regulation may not be fully captured during quiet standing alone; therefore, more demanding standing tasks may provide additional information about the ability of the postural control system to adapt to reduce base of support and increased sensorimotor demands.
Reflex Locomotion Therapy according to Vojta is a non-pharmacological neurorehabilitation approach based on sustained somatosensory stimulation applied to specific body zones. This stimulation is intended to activate automatic postural and movement patterns and may influence neuromotor control mechanisms involved in postural regulation. Although Vojta therapy has been used mainly in pediatric and neurological populations, evidence regarding its effects on postural control in older adults remains limited.
This exploratory randomized assessor -blinded study examined the acute effects of a single session of Vojta therapy on stabilometric variables of standing postural control in robust and prefrail older adults. The study was designed to characterize postural response under both quiet and challenging balance conditions, with special interest in task-dependent changes that could be relevant to fall-related postural control.
Centre of pressure variables were selected to provide a multidimensional characterization of postural control. Positional variables, including root mean square displacement in the mediolateral and anteroposterior directions, were used to characterize the magnitude of postural sway. Within the dynamic dimension, root mean square acceleration was considered the primary variables of corrective postural adjustments, complemented by mean velocity as a secondary variable of sway dynamics and postural effort. Spectral variables, including mean power frequency and dominant frequency in the mediolateral and anteroposterior directions, were used to describe the frequency domain organization of postural sway across the five standing conditions. Nonlinear variables, including sample entropy and Higuchi fractal dimension, were used to explore temporal regularity, predictability, and complexity of center of pressure fluctuations. Together, these measures were intended to capture complementary aspects of postural control beyond traditional sway magnitude.
- Conditions
- Postural Balance, Aging, Frailty
- Being tested
- Reflex Locomotion Therapy according to Vojta, Educational Session
- Keywords
- older adults, Vojta Therapy, Reflex Locomotion Therapy, Postural Control, Stabilometry, Center of pressure, Balance, Fall risk
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflex Locomotion Therapy according to VojtaOther
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.
Educational SessionBehavioural
An educational session focused on general health and well-being in older adulthood, delivered without physical therapy, balance exercises, or specific therapeutic stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Educational Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baselines, immediately post-intervention, and 20 minutes post-intervention
Secondary outcomes (5)
Change in Mean Center of Pressure Velocity During Standing Balance Tasks.
Mean center of pressure velocity is the average speed of displacement of the center over the recording period, reflecting the overall dynamics and effort of postural sway during standing. Higher values indicate faster CoP displacement and greater postural sway activity. It is expressed in cm/s.
Measured: 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.
Root mean square (RMS) displacement of the center of pressure in the mediolateral (ML) and anteroposterior (AP) directions quantifies the average magnitude of postural sway around the mean center of pressure position during standing, in each respective axis. Higher values indicate greater postural sway in that direction. It is expressed in cm
Measured: 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.
Mean power frequency (MPF) is the average frequency of the power spectrum of the center of pressure signal, weighted by spectral power, reflecting the overall frequency-domain organization of postural sway. Dominant frequency is the frequency at wich the power spectrum reaches its maximum value. Both measures are calculated in the mediolateral and anteroposterior directions and are expressed in Hz.
Measured: Baseline, immediately post-intervention, and 20 minutes post-intervention.
Change in Nonlinear Center of Pressure Measures During Standing Balance Tasks.
Sample entropy quantifies the regularity and predictability of center of pressure time series, with lower values indicating more regular and predictable postural sway, whereas higher values indicate greater irregularity and unpredictability. Higuchi fractal dimension quantifies the temporal complexity of center of pressure time series, with values closer to 1 indicating a smoother and less complex signal and values closer to 2 indicating greater complexity. Both measures are calculated separately for mediolateral (ML) and anteroposterior (AP) directions and are dimensionless.
Measured: Baseline, immediately post-intervention, and 20 minutes post-intervention
Adverse events and Tolerability during the Experimental Session
Adverse events, clinical complications, discomfort, or interruptions during the intervention and stabilometric assessments were recorder to describe safety and tolerability.
Measured: Baseline, immediately post-intervention, and 20 minutes post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start23 Jun 2025
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marianela Alejandra Valenzuela Sandoval
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Concepcion
- Responsible party
- Sponsor-investigator, Marianela Alejandra Valenzuela Sandoval, Universidad Metropolitana de Ciencias de la Educacion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829172
- Sponsor's protocol ID
- Vojta-352-2025
- Acronym
- VOJTABALANCE
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data has not yet been finalized. Any future sharing of anonymized data would be subject to participant confidentiality, ethical approval, institutional policies, and agreement among the study investigators.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Reflex Locomotion Therapy According to Vojta on Postural Control Task in Older Adults: An Exploratory Randomized Assessor-Blinded Study
- ClinicalTrials.gov ID
- NCT07829172
- Acronym / sponsor ID
- VOJTABALANCE / Vojta-352-2025
- Conditions
- Postural Balance, Aging, Frailty
- Keywords
- older adults, Vojta Therapy, Reflex Locomotion Therapy, Postural Control, Stabilometry, Center of pressure, Balance, Fall risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Marianela Alejandra Valenzuela SandovalUniversity, hospital or other
- Collaborators
- Universidad de Concepcion
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Detailed description
Falls and balance impairments are major health concerns in older adults because they are associated with functional decline, loss of independence, fear of falling, and increased healthcare burden. Postural control is a key modifiable factor related to fall risk. Subtle changes in postural regulation may not be fully captured during quiet standing alone; therefore, more demanding standing tasks may provide additional information about the ability of the postural control system to adapt to reduce base of support and increased sensorimotor demands.
Reflex Locomotion Therapy according to Vojta is a non-pharmacological neurorehabilitation approach based on sustained somatosensory stimulation applied to specific body zones. This stimulation is intended to activate automatic postural and movement patterns and may influence neuromotor control mechanisms involved in postural regulation. Although Vojta therapy has been used mainly in pediatric and neurological populations, evidence regarding its effects on postural control in older adults remains limited.
This exploratory randomized assessor -blinded study examined the acute effects of a single session of Vojta therapy on stabilometric variables of standing postural control in robust and prefrail older adults. The study was designed to characterize postural response under both quiet and challenging balance conditions, with special interest in task-dependent changes that could be relevant to fall-related postural control.
Centre of pressure variables were selected to provide a multidimensional characterization of postural control. Positional variables, including root mean square displacement in the mediolateral and anteroposterior directions, were used to characterize the magnitude of postural sway. Within the dynamic dimension, root mean square acceleration was considered the primary variables of corrective postural adjustments, complemented by mean velocity as a secondary variable of sway dynamics and postural effort. Spectral variables, including mean power frequency and dominant frequency in the mediolateral and anteroposterior directions, were used to describe the frequency domain organization of postural sway across the five standing conditions. Nonlinear variables, including sample entropy and Higuchi fractal dimension, were used to explore temporal regularity, predictability, and complexity of center of pressure fluctuations. Together, these measures were intended to capture complementary aspects of postural control beyond traditional sway magnitude.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vojta Therapy Group | Experimental | Other: Reflex Locomotion Therapy according to VojtaParticipants 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. |
| Educational Control Group | Active comparator | Behavioral: Educational SessionParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- - 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
Key exclusion criteria (6 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reflex Locomotion Therapy according to VojtaA 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. | Other | Vojta Therapy Group |
| Educational SessionAn educational session focused on general health and well-being in older adulthood, delivered without physical therapy, balance exercises, or specific therapeutic stimulation. | Behavioural | Educational Control Group |
Primary outcome
Change in Root Mean Square (RMS) of Center of Pressure Acceleration During Standing Balance Tasks.
Time frame: Baselines, immediately post-intervention, and 20 minutes post-intervention
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.
5 secondary outcomes
Change in Mean Center of Pressure Velocity During Standing Balance Tasks.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, immediately post-intervention, and 20 minutes post-intervention.
Change in Nonlinear Center of Pressure Measures During Standing Balance Tasks.
Time frame: Baseline, immediately post-intervention, and 20 minutes post-intervention
Adverse events and Tolerability during the Experimental Session
Time frame: Baseline, immediately post-intervention, and 20 minutes post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data has not yet been finalized. Any future sharing of anonymized data would be subject to participant confidentiality, ethical approval, institutional policies, and agreement among the study investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflex Locomotion Therapy according to Vojta and Educational Session in people with Postural Balance and Aging, run by Marianela Alejandra Valenzuela Sandoval at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Root Mean Square (RMS) of Center of Pressure Acceleration During Standing Balance Tasks. (time frame: Baselines, immediately post-intervention, and 20 minutes post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.