Vojta Therapy in Early Stroke Rehabilitation

Vojta Therapy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03035968
• Other study ID #: Höchster Vojta Stroke Studie
• Status: Completed
• Phase: N/A
• First received: January 24, 2017
• Last updated: January 26, 2018
• Start date: December 2, 2015
• Est. completion date: July 4, 2017

Study information

• Verified date: January 2018
• Source: Klinikum Frankfurt Höchst
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 4, 2017
• Est. primary completion date: April 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Reflex Locomotion
• Stroke
• Vojta Therapy

Intervention

Other:
• Vojta therapy

• conventional physiotherapy

Locations

Country	Name	City	State
Germany	Klinikum Frankfurt Höchst	Frankfurt am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Corina Epple

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1-9 after admission to hospital (+/- 1)
Secondary	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.	Day 1-9 after hospital admission (+/- 1)
Secondary	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.	Day 1-9 after hospital admission (+/- 1)
Secondary	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.	Day 1-9 after hospital admission (+/- 1)
Secondary	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.	Day 1-9 after hospital admission (+/- 1)
Secondary	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.	Day 1-9.
Secondary	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.	Day 1-9.
Secondary	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	Day 90 after stroke onset
Secondary	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	Day 90 after stroke onset

External Links

•   Homepage of the International Vojta Society