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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vojta Therapy
- Sponsor
- Corina Epple
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Improvement of postural control measured with the trunc control test (TCT) on day 9 after admission to the hospital
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Corina Epple
Principle Investigator
Klinikum Frankfurt Höchst
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
Outcomes
Primary Outcomes
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
- Improvement of the neglect (measured with the Catherine Bergego Scale) before and after every single intervention.(Day 1-9.)
- 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)(Day 1-9 after hospital admission (+/- 1))
- Improvement of the Barthel Index on day 9 after admission to the hospital(Day 1-9 after hospital admission (+/- 1))
- Improvement of arm motor function (measured with the MESUPES) before and after every single intervention.(Day 1-9.)
- 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)(Day 1-9 after hospital admission (+/- 1))
- Improvement of the Barthel Index on day 90 after stroke onset(Day 90 after stroke onset)
- Improvement of the NIHSS on day 9 after admission to the hospital(Day 1-9 after hospital admission (+/- 1))
- Improvement of the modified Rankin Scale (mRS) on day 90 after stroke onset(Day 90 after stroke onset)