Stroke, IschemicNCT07307001
Vojta Therapy Versus Conservative Therapy for Patients With Stroke
A study testing Vojta therapy and Conservative therapy in people with Stroke, Ischemic, run by Lucaci Doru Nicolae at 1 site in Romania.
Trial summary
Main hypothesis: Vojta Therapy shows significantly better results in regaining functional independence for patients with ischemic stroke than the Conservative Therapy The present study wishes to bring evidence that Vojta Therapy is superior in regaining functional independence for patients with ischemic stroke… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Vojta therapy and Conservative therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRomania
- Study dates
- 2 Feb 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients post-ischemic stroke
- patients who meet the age criteria
- patients who have had the stroke in less than 3 years ago
Who cannot join
- patients with hemoragic stroke
- patients with comorbidities
- noncooperative patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site
Auxologico President Recovery Hospital
Cordău, 417499
Laszlo Ritli, +40 744 797 439, ritlil2018@gmail.com
Doru Nicolae Lucaci, PhD
About this study
Official title: Vojta Therapy Versus Conservative Therapy for Patients With Ischemic Stroke in Regaining Functional Independence
Main hypothesis: Vojta Therapy shows significantly better results in regaining functional independence for patients with ischemic stroke than the Conservative Therapy
The present study wishes to bring evidence that Vojta Therapy is superior in regaining functional independence for patients with ischemic stroke, whether it is solely used in the intervention, or as a complementary tool along with the Conservative Therapy.
- Conditions
- Stroke, Ischemic
- Being tested
- Vojta therapy, Conservative therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vojta therapyProcedure or surgery
The physiotherapists will apply the techniques and methods of Vojta therapy along with the classical tools of the Conservative therapy. Through the therapeutic use of reflex locomotion involved in Vojta sessions, it can succeed in elementary movement models, meaning that they can be accessible again for patients with central nervous system and musculoskeletal affections.
Conservative therapyProcedure or surgery
The physiotherapists will apply only the classical tools and methods involved in the Conservative therapy (Bobath, massage, electrotherapy, hydrotherapy).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The physiotherapists will apply only the Conservative Therapy to the subjects in this group Receives: Procedure: Conservative therapy |
| Study Group | Experimental | The physiotherapists will apply the Conservative Therapy, and in addition will also apply the Vojta Therapy Receives: Procedure: Vojta therapy; Procedure: Conservative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Control Test (TCT)
The Trunk Control Test (TCT) will be used to assess the motor function and control of the trunk in participants. The scale contains 5 task-items, each of them being scored between 0 (unable, needs help), 12 (able but abnormal), or 25 (able, normal). The scoring interval is 0-100, where 100 signify better trunk function, and 0 none.
Measured: From enrollment to the end of treatment at 2 weeks, and a follow up at 3 months
Functional Independence Measure (FIM)
The Functional Independence Measure (FIM) will be used to assess the level of a participant's functional independence in activities of daily living. The test comprises in 18 items, each of which is assigned against a seven-point ordinal scale, where the higher the score for an item, the more independently the patient is able to perform the tasks assessed by that item. Total scores range from 18 to 126.
Measured: From enrollment to the end of treatment at 2 weeks, and a follow-up at 3 months
Secondary outcomes (8)
Trunk Impairment Scale (TIS)
The Trunk Impairment Scale (TIS) aims to evaluate the trunk in patients who have suffered a stroke. The scale contains 3 subscales (static, dynamic and coordonation), totalling a number of 17 items. The total score varies from 0 to 23, 0 meaning worse trunk control, and 23 best trunk control.
Measured: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months
Postural Assessment Scale for Stroke (PASS)
The PASS scale is used to measure balance and postural control in stroke survivors across lying, sitting and standing positions. The scale contains 3 subscales (lying, sitting, standing), and 12 tasks, with a total score varying between 0 (worse posture) and 36 (better posture).
Measured: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.
Berg Balance Scale (BBS)
The BBS scale is used to objectively determine a patient's ability to safely balance during a series of predetermined tasks. The scale contains 14 standardized tasks, scored from 0 (unable), to 4 (independent) for a total of 56 points.
Measured: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.
Barthel Index
The Barthel Index scale is an ordinal scale which measures a person's ability to complete ADL. The scale evaluates performance in 10 areas, with scores of 0, 5, or 10 for each item. A total score of 0 means total dependence, while 100 means independent.
Measured: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.
Nottingham Extended ADL
The NEADL scale is a self-report questionnaire used in rehabilitation especially post-stroke, to measure independence in broader daily tasks beyond basic ones. It scores independence on a scale (0-1 or 0-2 points per item, total max 22) with higher scores indicating greater independence. The scale contains 22 items.
Measured: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.
Functional Ambulation Categories (FAC)
The FAC scale is a 6 point (0-nonfunctional ambulator; 5-ambulator/independent) functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking. It is not a multi-item questionnaire.
Measured: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.
Rivermead Mobility Index (RMI)
The RMI scale is a quick tool assessing 15 activities, like turning in bed, sitting balance, transfers, etc. often after stroke/head injury. Scoring varies between 0 (unable) and 1 (able), with a maximum score of 15, higher scores indicating better mobility.
Measured: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.
Wisconsin Gait Scale (WGS)
The WGS scale is used to monitor the effectiveness of rehabilitation training and the gate problems experienced by the patients after a stroke. With a number of 14 items, the test is generally scored between 1 (normal) and 3 (atypical), with the gait aid item scored 1-5, and knee flexion scored 1-4.
Measured: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start2 Feb 2026 (estimated)
- Primary completion29 May 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lucaci Doru Nicolae
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lucaci Doru Nicolae, President Premium Medcenter
- Investigators
- Doru Nicolae Lucaci, PhD, Principal investigator, Auxologico President
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307001
- Sponsor's protocol ID
- 85/22.05.2025
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patient's personal details are strictly confidential. Only the demographic data will be available.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vojta Therapy Versus Conservative Therapy for Patients With Ischemic Stroke in Regaining Functional Independence
- ClinicalTrials.gov ID
- NCT07307001
- Acronym / sponsor ID
- 85/22.05.2025
- Conditions
- Stroke, Ischemic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lucaci Doru NicolaeUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 29 May 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 29 Dec 2025 (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.
Main hypothesis: Vojta Therapy shows significantly better results in regaining functional independence for patients with ischemic stroke than the Conservative Therapy
The present study wishes to bring evidence that Vojta Therapy is superior in regaining functional independence for patients with ischemic stroke, whether it is solely used in the intervention, or as a complementary tool along with the Conservative Therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Conservative therapyThe physiotherapists will apply only the Conservative Therapy to the subjects in this group |
| Study Group | Experimental | Procedure: Vojta therapy, Procedure: Conservative therapyThe physiotherapists will apply the Conservative Therapy, and in addition will also apply the Vojta Therapy |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients post-ischemic stroke
- patients who meet the age criteria
- patients who have had the stroke in less than 3 years ago
Key exclusion criteria (3 listed)
- patients with hemoragic stroke
- patients with comorbidities
- noncooperative patients
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 |
|---|---|---|
| Vojta therapyThe physiotherapists will apply the techniques and methods of Vojta therapy along with the classical tools of the Conservative therapy. Through the therapeutic use of reflex locomotion involved in Vojta sessions, it can succeed in elementary movement models, meaning that they can be accessible again for patients with central nervous system and musculoskeletal affections. | Procedure or surgery | Study Group |
| Conservative therapyThe physiotherapists will apply only the classical tools and methods involved in the Conservative therapy (Bobath, massage, electrotherapy, hydrotherapy). | Procedure or surgery | Control group, Study Group |
Primary outcome
Trunk Control Test (TCT)
Time frame: From enrollment to the end of treatment at 2 weeks, and a follow up at 3 months
The Trunk Control Test (TCT) will be used to assess the motor function and control of the trunk in participants. The scale contains 5 task-items, each of them being scored between 0 (unable, needs help), 12 (able but abnormal), or 25 (able, normal). The scoring interval is 0-100, where 100 signify better trunk function, and 0 none.
Functional Independence Measure (FIM)
Time frame: From enrollment to the end of treatment at 2 weeks, and a follow-up at 3 months
The Functional Independence Measure (FIM) will be used to assess the level of a participant's functional independence in activities of daily living. The test comprises in 18 items, each of which is assigned against a seven-point ordinal scale, where the higher the score for an item, the more independently the patient is able to perform the tasks assessed by that item. Total scores range from 18 to 126.
8 secondary outcomes
Trunk Impairment Scale (TIS)
Time frame: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months
Postural Assessment Scale for Stroke (PASS)
Time frame: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.
Berg Balance Scale (BBS)
Time frame: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.
Barthel Index
Time frame: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.
Nottingham Extended ADL
Time frame: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.
Functional Ambulation Categories (FAC)
Time frame: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.
Rivermead Mobility Index (RMI)
Time frame: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.
Wisconsin Gait Scale (WGS)
Time frame: From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No. The patient's personal details are strictly confidential. Only the demographic data will be available.
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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.
Doru Nicolae Lucaci, PhD principal investigator
Auxologico President
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vojta therapy and Conservative therapy in people with Stroke, Ischemic, run by Lucaci Doru Nicolae at 1 site in Romania.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 7 Jan 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 Romania. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doru Nicolae Lucaci, PhD (+40744664991, lucaci_doru2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Control Test (TCT) (time frame: From enrollment to the end of treatment at 2 weeks, and a follow up at 3 months). The study lists 2 primary outcomes in all. 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 7 Jan 2026.