Vojta Therapy, Reflex Locomotion
Conditions
Keywords
Vojta therapy, reflex locomotion, stroke rehabilitation, stroke, physiotherapy
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.
Interventions
OTHERVojta therapy
OTHERconventional physiotherapy
Sponsors
Corina Epple
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of postural control measured with the trunc control test (TCT) on day 9 after admission to the hospital | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 | 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 | 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 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) | 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 MESUPES) before and after every single intervention. | 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 | 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 | 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 |
| Improvement of the neglect (measured with the Catherine Bergego Scale) before and after every single intervention. | 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. |
Countries
Germany
Outcome results
None listed