NCT07307001

Brief 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, whether it is solely used in the intervention, or as a complementary tool along with the Conservative Therapy.

Trial Health

63
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Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress53%
Feb 2026Jul 2026

First Submitted

Initial submission to the registry

December 13, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 13, 2025

Last Update Submit

January 6, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From enrollment to the end of treatment at 2 weeks, and a follow-up at 3 months

Secondary Outcomes (8)

  • Trunk Impairment Scale (TIS)

    From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months

  • Postural Assessment Scale for Stroke (PASS)

    From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.

  • Berg Balance Scale (BBS)

    From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.

  • Barthel Index

    From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.

  • Nottingham Extended ADL

    From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.

  • +3 more secondary outcomes

Other Outcomes (3)

  • Stroke Impact Scale (SIS)

    From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.

  • EuroQol-5 Dimension (EQ-5D)

    From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.

  • Stroke Specific Quality of Life (SS-QoL)

    From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.

Study Arms (2)

Control group

ACTIVE COMPARATOR

The physiotherapists will apply only the Conservative Therapy to the subjects in this group

Procedure: Conservative therapy

Study Group

EXPERIMENTAL

The physiotherapists will apply the Conservative Therapy, and in addition will also apply the Vojta Therapy

Procedure: Vojta therapyProcedure: Conservative therapy

Interventions

Vojta therapyPROCEDURE

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.

Study Group

The physiotherapists will apply only the classical tools and methods involved in the Conservative therapy (Bobath, massage, electrotherapy, hydrotherapy).

Control groupStudy Group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients post-ischemic stroke
  • patients who meet the age criteria
  • patients who have had the stroke in less than 3 years ago

You may not qualify if:

  • patients with hemoragic stroke
  • patients with comorbidities
  • noncooperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auxologico President Recovery Hospital

Cordău, 417499, Romania

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Doru Nicolae Lucaci, PhD

    Auxologico President

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doru Nicolae Lucaci, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

December 13, 2025

First Posted

December 29, 2025

Study Start

February 2, 2026

Primary Completion (Estimated)

May 29, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

January 7, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

The patient's personal details are strictly confidential. Only the demographic data will be available.

Locations