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Completed

NCT Number: NCT03035968

Vojta Therapy in Early Stroke Rehabilitation

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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Key information

Conditions

Vojta Therapy Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Reflex Locomotion Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Frankfurt Höchst

Frankfurt am Main, Hesse, 60311, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vojta Therapy

Other

Other names: reflex locomotion

Conventional Physiotherapy

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Corina Epple

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2017
Registry last updated
Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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