Clinical trial NCT03035968: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vojta Therapy
Reflex Locomotion
Keywords: Vojta therapy
reflex locomotion
stroke rehabilitation
stroke
physiotherapy
Lead sponsor: Klinikum Frankfurt Höchst
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Improvement of postural control measured with the trunc control test (TCT) on day 9 after admission to the hospital
timeFrame: Day 1-9 after admission to hospital (+/- 1)
Secondary outcomes:
measure: 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)
timeFrame: Day 1-9 after hospital admission (+/- 1)
measure: 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)
timeFrame: Day 1-9 after hospital admission (+/- 1)
measure: Improvement of the Barthel Index on day 9 after admission to the hospital
timeFrame: Day 1-9 after hospital admission (+/- 1)
measure: Improvement of the NIHSS on day 9 after admission to the hospital
timeFrame: Day 1-9 after hospital admission (+/- 1)
measure: Improvement of the neglect (measured with the Catherine Bergego Scale) before and after every single intervention.
timeFrame: Day 1-9.
measure: Improvement of arm motor function (measured with the MESUPES) before and after every single intervention.
timeFrame: Day 1-9.
measure: Improvement of the modified Rankin Scale (mRS) on day 90 after stroke onset
timeFrame: Day 90 after stroke onset
measure: Improvement of the Barthel Index on day 90 after stroke onset
timeFrame: Day 90 after stroke onset
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Klinikum Frankfurt Höchst
state: Hessen
Study officials:
References:
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.