Vojta Therapy Versus Conservative Therapy for Patients With Stroke

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Procedure: Conservative therapy; Procedure: Vojta therapy

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doru Nicolae Lucaci, PhD; Phone Number: +40744664991; Email: lucaci_doru2001@yahoo.com

Study Locations

• Romania
  • Cordău, Romania, 417499
    • Auxologico President Recovery Hospital
    • Contact: Laszlo Ritli; Phone Number: ‪+40 744 797 439‬; Email: ritlil2018@gmail.com
    • Principal Investigator: Doru Nicolae Lucaci, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; The physiotherapists will apply only the Conservative Therapy to the subjects in this group	Procedure: Conservative therapy; The physiotherapists will apply only the classical tools and methods involved in the Conservative therapy (Bobath, massage, electrotherapy, hydrotherapy).
Experimental: Study Group; The physiotherapists will apply the Conservative Therapy, and in addition will also apply the Vojta Therapy	Procedure: Conservative therapy; The physiotherapists will apply only the classical tools and methods involved in the Conservative therapy (Bobath, massage, electrotherapy, hydrotherapy).; Procedure: Vojta therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	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.	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.	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.	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.	From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Impact Scale (SIS)	The SIS scale is a patient-reported outcome measure that evaluates the biopsychosocial aspects of life after stroke. The scale contains 59 items regarding daily acitivites, on a 5-point scale for each item, a greater score meaning less dificulty.	From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.
EuroQol-5 Dimension (EQ-5D)	The EQ-5D scale is a widely used health questionnaire assessing health-related quality of life, focusing on 5 key areas, with a visual analog scale (VAS). The test contains only 5 items regarding 5 the 5 areas. Scoring for this test is a 5 digit generated code, that is converted into a single utility score (0=death, 1=perfect health).	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)	The SS-QoL scale is a patient-reported tool for assessing health related quality of life in stroke survivors, measuring impacts on daily function, emotions, social roles, and cognition across 12 key domains and 49 items. Scoring for this test varies between 49-245, each item being scored between 1 (total help) and 5 (no help needed).	From enrollment to the end of the treatment at 2 weeks, and a follow-up at 3 months.

Collaborators and Investigators

• Sponsor: Lucaci Doru Nicolae
• Investigators: Principal Investigator: Doru Nicolae Lucaci, PhD, Auxologico President

Study record dates

Study Major Dates

• Study Start (Estimated): February 2, 2026
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: December 13, 2025
• First Submitted That Met QC Criteria: December 13, 2025
• First Posted (Estimated): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Therapeutics; Conservative Treatment
• Other Study ID Numbers: 85/22.05.2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The patient's personal details are strictly confidential. Only the demographic data will be available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No