Vojta TherapyNCT03035968
Vojta Therapy in Early Stroke Rehabilitation
A study testing Vojta therapy and conventional physiotherapy in people with Vojta Therapy and Reflex Locomotion, run by Corina Epple at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vojta Therapy, Reflex Locomotion
- What is being tested?
- Vojta therapy and conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 2 Dec 2015to 4 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe cognitive impairment due to aphasia or dementia, prohibiting that physiotherapeutic challenges can be understood.
- Participation on another clinical trial
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Vojta therapy, conventional physiotherapy
- Keywords
- Vojta therapy, reflex locomotion, stroke rehabilitation, stroke, physiotherapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vojta therapyOther
Also called reflex locomotion
conventional physiotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Vojta arm | Experimental | Patients in the interventional arm are treated with Vojta therapy from randomization until discharge. Receives: 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. Receives: Other: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Day 1-9 after hospital admission (+/- 1)
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.
Measured: Day 1-9 after hospital admission (+/- 1)
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.
Measured: Day 1-9 after hospital admission (+/- 1)
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.
Measured: Day 1-9.
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.
Measured: Day 1-9.
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
Measured: Day 90 after stroke onset
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
Measured: Day 90 after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start2 Dec 2015
- Primary completion14 Apr 2017
- Study completion4 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vojta TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corina Epple
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Corina Epple, Klinikum Frankfurt Höchst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035968
- Sponsor's protocol ID
- Höchster Vojta Stroke Studie
- Status last verified
- Jan 2018
- First submitted
- 24 Jan 2017
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33324926
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03035968
- Acronym / sponsor ID
- Höchster Vojta Stroke Studie
- Conditions
- Vojta Therapy, Reflex Locomotion
- Keywords
- Vojta therapy, reflex locomotion, stroke rehabilitation, stroke, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Corina EppleUniversity, hospital or other
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- 4 Jul 2017 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vojta arm | Experimental | Other: Vojta therapyPatients in the interventional arm are treated with Vojta therapy from randomization until discharge. |
| conventional physiotherapy arm | Active comparator | Other: conventional physiotherapyPatients in this control arm are treated with conventional physiotherapy for motor improvement from randomization until discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Severe cognitive impairment due to aphasia or dementia, prohibiting that physiotherapeutic challenges can be understood.
- Participation on another clinical trial
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vojta therapyAlso: reflex locomotion | Other | Vojta arm |
| conventional physiotherapy | Other | conventional physiotherapy arm |
Primary outcome
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.
8 secondary outcomes
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)
Time frame: 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)
Time frame: Day 1-9 after hospital admission (+/- 1)
Improvement of the Barthel Index on day 9 after admission to the hospital
Time frame: Day 1-9 after hospital admission (+/- 1)
Improvement of the NIHSS on day 9 after admission to the hospital
Time frame: Day 1-9 after hospital admission (+/- 1)
Improvement of the neglect (measured with the Catherine Bergego Scale) before and after every single intervention.
Time frame: Day 1-9.
Improvement of arm motor function (measured with the MESUPES) before and after every single intervention.
Time frame: Day 1-9.
Improvement of the modified Rankin Scale (mRS) on day 90 after stroke onset
Time frame: Day 90 after stroke onset
Improvement of the Barthel Index on day 90 after stroke onset
Time frame: Day 90 after stroke onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Derived from this study: PubMed 33324926Epple 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.
- Homepage of the International Vojta SocietyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Vojta Therapy
Not yet recruiting
Vojta Therapy Versus Conservative Therapy for Patients With Stroke
Stroke, Ischemic
Recruiting
Effects of Vojta Therapy on Posture and Trunk Control
Stroke, Stroke Ischemic
Recruiting
Effects of Vojta Therapy on Functional Mobility and Gait Parameters in Children With Down Syndrome
Down Syndrome
Enrolling by invitation
EEG and NIRS in Preterm Infants
Premature Birth
Active, not recruiting
Comparative Effect of Vojta Therapy and Bobath Therapy on Lower Limb Spasticity and Motorcity Among HS
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vojta therapy and conventional physiotherapy in people with Vojta Therapy and Reflex Locomotion, run by Corina Epple at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03035968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.