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Vojta Therapy in Early Stroke Rehabilitation

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ClinicalTrials.gov Identifier: NCT03035968
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Corina Epple, Klinikum Frankfurt Höchst

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vojta Therapy Reflex Locomotion Other: Vojta therapy Other: conventional physiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 2, 2015
Actual Primary Completion Date : April 14, 2017
Actual Study Completion Date : July 4, 2017

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Arm Intervention/treatment
Experimental: Vojta arm
Patients in the interventional arm are treated with Vojta therapy from randomization until discharge.
Other: Vojta therapy
Other Name: reflex locomotion

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



Primary Outcome Measures :
  1. Improvement of postural control measured with the trunc control test (TCT) on day 9 after admission to the hospital [ Time Frame: Day 1-9 after admission to hospital (+/- 1) ]
    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.


Secondary Outcome Measures :
  1. 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) [ Time Frame: Day 1-9 after hospital admission (+/- 1) ]
    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.

  2. 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) [ Time Frame: Day 1-9 after hospital admission (+/- 1) ]
    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.

  3. Improvement of the Barthel Index on day 9 after admission to the hospital [ Time Frame: Day 1-9 after hospital admission (+/- 1) ]
    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.

  4. Improvement of the NIHSS on day 9 after admission to the hospital [ Time Frame: Day 1-9 after hospital admission (+/- 1) ]
    The NIHSS is assessed before the first treatment on day 2 and after the last intervention on day 9 (+/-1) after admission to hospital.

  5. Improvement of the neglect (measured with the Catherine Bergego Scale) before and after every single intervention. [ Time Frame: Day 1-9. ]
    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.

  6. Improvement of arm motor function (measured with the MESUPES) before and after every single intervention. [ Time Frame: Day 1-9. ]
    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.

  7. Improvement of the modified Rankin Scale (mRS) on day 90 after stroke onset [ Time Frame: 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

  8. Improvement of the Barthel Index on day 90 after stroke onset [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035968


Locations
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Germany
Klinikum Frankfurt Höchst
Frankfurt am Main, Hessen, Germany, 60311
Sponsors and Collaborators
Corina Epple

Additional Information:
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Responsible Party: Corina Epple, Principle Investigator, Klinikum Frankfurt Höchst
ClinicalTrials.gov Identifier: NCT03035968     History of Changes
Other Study ID Numbers: Höchster Vojta Stroke Studie
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Corina Epple, Klinikum Frankfurt Höchst:
Vojta therapy
reflex locomotion
stroke rehabilitation
stroke
physiotherapy

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases