Vojta Therapy in Early Stroke Rehabilitation

NCT03035968 | Completed

• 1 other identifier: Höchster Vojta Stroke Studie
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vojta Therapy; Reflex Locomotion

Keywords

Vojta therapy; reflex locomotion; stroke rehabilitation; stroke; physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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 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 the NIHSS on day 9 after admission to the hospital

  Day 1-9 after hospital admission (+/- 1)

• Improvement of the neglect (measured with the Catherine Bergego Scale) before and after every single intervention.

  Day 1-9.

Study Arms (2)

Vojta arm

EXPERIMENTAL

Patients in the interventional arm are treated with Vojta therapy from randomization until discharge.

Other: Vojta therapy

conventional physiotherapy arm

ACTIVE COMPARATOR

Patients in this control arm are treated with conventional physiotherapy for motor improvement from randomization until discharge.

Other: conventional physiotherapy

Interventions

Vojta therapy OTHER

Also known as: reflex locomotion

Vojta arm

conventional physiotherapy OTHER

conventional physiotherapy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe cognitive impairment due to aphasia or dementia, prohibiting that physiotherapeutic challenges can be understood.
• Participation on another clinical trial
• Pregnancy

Sponsors & Collaborators

• Corina Epple: lead

Study Sites (1)

Klinikum Frankfurt Höchst

Frankfurt am Main, Hesse, 60311, Germany

Location

Related Publications (1)

• 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.

  PMID: 33324926 DERIVED

Related Links

• Homepage of the International Vojta Society

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 30, 2017
• Study Start: December 2, 2015
• Primary Completion: April 14, 2017
• Study Completion: July 4, 2017
• Last Updated: January 29, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)