Vojta Therapy in Early Stroke Rehabilitation

Study Overview
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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.

Official Title
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Improvement of Postural Control and Motor Function by Vojta Therapy in Early Stroke Rehabilitation of Stroke Patients - a Pilot Study and New Approach in Stroke Rehabilitation

Conditions
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Reflex Locomotion, Vojta Therapy

Intervention / Treatment
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* Other: Vojta therapy
* Other: conventional physiotherapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vojta arm<br>Patients in the interventional arm are treated with Vojta therapy from randomization until discharge. | Other: Vojta therapy<br> <br> * Other names: reflex locomotion;|
| Active Comparator: conventional physiotherapy arm<br>Patients in this control arm are treated with conventional physiotherapy for motor improvement from randomization until discharge. | Other: conventional physiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of postural control measured with the trunc control test (TCT) on day 9 after admission to the hospital | The Trunc Control Test (TCT) is a valid test to asses motor impairment after stroke. A range of 0 to 100 points can be achieved. Patients are tested before the first treatment on day 2, after 5 days and after the last intervention on day 9 (+/-1) after admission to hospital. | Day 1-9 after admission to hospital (+/- 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of neglect measured with the Catherine Bergego Scale (part 5 and 6) after on day 9 after admission to the hospital (compared to baseline) | The neglect is assessed with part 5 and 6 of the Catherine Bergego Scale. Patients are tested before and after the first treatment on day 2, before and after treatment after 5 days and before and after the last intervention on day 9 (+/-1) after admission to hospital. | Day 1-9 after hospital admission (+/- 1) | 
| Improvement of arm motor function measured with the motor evaluation scale for upper extremity in stroke patients [MESUPES, part 1 to 4] on day 9 after admission to the hospital (compared to baseline) | The arm motor function is assessed with part 1 to 4 of the MESUPES. Patients are tested before and after the first treatment on day 2, before and after treatment after 5 days and before and after the last intervention on day 9 (+/-1) after admission to hospital. | Day 1-9 after hospital admission (+/- 1) | 
| Improvement of the Barthel Index on day 9 after admission to the hospital | The Barthel Index is assessed before the first treatment on day 2 and after the last intervention on day 9 (+/-1) after admission to hospital. | Day 1-9 after hospital admission (+/- 1) | 
| Improvement of the NIHSS on day 9 after admission to the hospital | The NIHSS is assessed before the first treatment on day 2 and after the last intervention on day 9 (+/-1) after admission to hospital. | Day 1-9 after hospital admission (+/- 1) | 
| Improvement of the neglect (measured with the Catherine Bergego Scale) before and after every single intervention. | Patients are assessed for the neglect 3 times: on day 2, day 5 and day 9 (plus/minus 1 day) after admission to hospital before and after treatment. We want to compare if there is an improvement of the neglect directly after treatment. | Day 1-9. | 
| Improvement of arm motor function (measured with the MESUPES) before and after every single intervention. | Patients are assessed for the motor function 3 times: on day 2, day 5 and day 9 (plus/minus 1 day) after admission to hospital before and after treatment. We want to compare if there is an improvement of motor function directly after treatment. | Day 1-9. | 
| Improvement of the modified Rankin Scale (mRS) on day 90 after stroke onset | The mRS is assessed before the first treatment on day 2 after admission to hospital (before treatment) and on day 90 after stroke onset. The 90 day mRS is assessed via telephone interview by a blinded assessor | Day 90 after stroke onset | 
| Improvement of the Barthel Index on day 90 after stroke onset | The Barthel Index is assessed before the first treatment on day 2 after admission to hospital (before treatment) and on day 90 after stroke onset. The 90 day Barthel Index is assessed via telephone interview by a blinded assessor | Day 90 after stroke onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vojta therapy, reflex locomotion, stroke rehabilitation, stroke, physiotherapy