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Vojta Therapy in Early Stroke Rehabilitation

Primary Purpose

Vojta Therapy, Reflex Locomotion

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Vojta therapy
conventional physiotherapy
Sponsored by
Corina Epple
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vojta Therapy focused on measuring Vojta therapy, reflex locomotion, stroke rehabilitation, stroke, physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum Frankfurt Höchst

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vojta arm

conventional physiotherapy arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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
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

Full Information

First Posted
January 24, 2017
Last Updated
January 26, 2018
Sponsor
Corina Epple
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1. Study Identification

Unique Protocol Identification Number
NCT03035968
Brief Title
Vojta Therapy in Early Stroke Rehabilitation
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 2, 2015 (Actual)
Primary Completion Date
April 14, 2017 (Actual)
Study Completion Date
July 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Corina Epple

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vojta Therapy, Reflex Locomotion
Keywords
Vojta therapy, reflex locomotion, stroke rehabilitation, stroke, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vojta arm
Arm Type
Experimental
Arm Description
Patients in the interventional arm are treated with Vojta therapy from randomization until discharge.
Arm Title
conventional physiotherapy arm
Arm Type
Active Comparator
Arm Description
Patients in this control arm are treated with conventional physiotherapy for motor improvement from randomization until discharge.
Intervention Type
Other
Intervention Name(s)
Vojta therapy
Other Intervention Name(s)
reflex locomotion
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Primary Outcome Measure Information:
Title
Improvement of postural control measured with the trunc control test (TCT) on day 9 after admission to the hospital
Description
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.
Time Frame
Day 1-9 after admission to hospital (+/- 1)
Secondary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Day 1-9 after hospital admission (+/- 1)
Title
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)
Description
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.
Time Frame
Day 1-9 after hospital admission (+/- 1)
Title
Improvement of the Barthel Index on day 9 after admission to the hospital
Description
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.
Time Frame
Day 1-9 after hospital admission (+/- 1)
Title
Improvement of the NIHSS on day 9 after admission to the hospital
Description
The NIHSS is assessed before the first treatment on day 2 and after the last intervention on day 9 (+/-1) after admission to hospital.
Time Frame
Day 1-9 after hospital admission (+/- 1)
Title
Improvement of the neglect (measured with the Catherine Bergego Scale) before and after every single intervention.
Description
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.
Time Frame
Day 1-9.
Title
Improvement of arm motor function (measured with the MESUPES) before and after every single intervention.
Description
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.
Time Frame
Day 1-9.
Title
Improvement of the modified Rankin Scale (mRS) on day 90 after stroke onset
Description
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
Time Frame
Day 90 after stroke onset
Title
Improvement of the Barthel Index on day 90 after stroke onset
Description
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
Time Frame
Day 90 after stroke onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Klinikum Frankfurt Höchst
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60311
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33324926
Citation
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.
Results Reference
derived
Links:
URL
http://www.vojta.com
Description
Homepage of the International Vojta Society

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Vojta Therapy in Early Stroke Rehabilitation

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