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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

Tracking Information
First Submitted Date  ICMJE January 24, 2017
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date January 29, 2018
Actual Study Start Date  ICMJE December 2, 2015
Actual Primary Completion Date April 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vojta Therapy in Early Stroke Rehabilitation
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Vojta Therapy
  • Reflex Locomotion
Intervention  ICMJE
  • Other: Vojta therapy
    Other Name: reflex locomotion
  • Other: conventional physiotherapy
Study Arms  ICMJE
  • Experimental: Vojta arm
    Patients in the interventional arm are treated with Vojta therapy from randomization until discharge.
    Intervention: Other: Vojta therapy
  • Active Comparator: conventional physiotherapy arm
    Patients in this control arm are treated with conventional physiotherapy for motor improvement from randomization until discharge.
    Intervention: Other: conventional physiotherapy
Publications * Epple C, Maurer-Burkhard B, Lichti MC, Steiner T. Vojta therapy improves postural control in very early stroke rehabilitation: a randomised controlled pilot trial. Neurol Res Pract. 2020 Aug 20;2:23. doi: 10.1186/s42466-020-00070-4. eCollection 2020.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 4, 2017
Actual Primary Completion Date April 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03035968
Other Study ID Numbers  ICMJE Höchster Vojta Stroke Studie
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Corina Epple, Klinikum Frankfurt Höchst
Study Sponsor  ICMJE Corina Epple
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Klinikum Frankfurt Höchst
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP