Vojta Therapy in Early Stroke Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-02

Study Completion Date

2017-07-04

Brief Summary

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Stroke is the major cause for permanent disability in adults. It is still unclear, which physiotherapeutic approaches are most effective. The Bobath-concept is one of the most widely used approaches in stroke rehabilitation within the western world, although several studies have failed to demonstrate superiority and showed partially even inferiority compared to other physiotherapy approaches. The Vojta therapy is based on a completely different approach - the reflex locomotion. However to date no study has been performed for stroke. We designed a randomized clinical trial (RCT) to compare Vojta and conventional physiotherapy in patients with acute ischemic (AIS) or hemorrhagic stroke (ICH). This RCT will be the first trial to investigate improvement of postural control due to Vojta therapy in early rehabilitation of stroke patients, which is a very new approach in stroke-rehabilitation.

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Detailed Description

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Conditions

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Vojta Therapy Reflex Locomotion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The assessor for the secondary outcome (Barthel Index and mRS after 90 days) is blinded. All other outcome assessors have knowledge of the interventions assigned to individual participants.

Study Groups

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Vojta arm

Patients in the interventional arm are treated with Vojta therapy from randomization until discharge.

Group Type EXPERIMENTAL

Vojta therapy

Intervention Type OTHER

conventional physiotherapy arm

Patients in this control arm are treated with conventional physiotherapy for motor improvement from randomization until discharge.

Group Type ACTIVE_COMPARATOR

conventional physiotherapy

Intervention Type OTHER

Interventions

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Vojta therapy

Intervention Type OTHER

conventional physiotherapy

Intervention Type OTHER

Other Intervention Names

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reflex locomotion

Eligibility Criteria

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Inclusion Criteria

* Adult patients (\> 18 years)
* CT or MRI proven acute ischemic (AIS) or hemorrhagic stroke (ICH) within 72h after onset of symptoms
* Severe hemiparesis (medical research council scale for muscle strength ≤2)
* premorbid modified Rankin Scale (mRS) ≤3
* maximal National Institute of Health Stroke Scale Score (NIHSS) 25
* Voluntary written consent by the patient

Exclusion Criteria

* Severe cognitive impairment due to aphasia or dementia, prohibiting that physiotherapeutic challenges can be understood.
* Participation on another clinical trial
* Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No