Follow-up Study of the Effectiveness of Virtual Reality Therapy in Patients With Stroke
October 13, 2020 updated by: Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
High intensity motion improves motor functions and quality of life in a neurologist.
The investigators want to improve the clinical condition and quality of life of post-STROKE participants with a special sensory motor and visual motor agility therapy.
High intensity motion improves engine function and quality of life in a neurologist.
With special sensory motor and visual motility, investigaters want to improve the clinical condition and quality of life of STROKE participants.
The investigaters randomly select participants who only perform the rehabilitation treatment have performed.
The other group that will receive the study's control group will receive the traditional rehabilitation physiotherapy treatment.
The investigaters assess the condition and quality of life of the patients.
(EQ5-D, Barthel index, MRS test) The ivestigaters examine the functional movement and equilibrium variables of patients.
(6MWT, Berg balance test, postgraduation) After that, participants are undergoing a 4-week intensive rehabilitation treatment.
All participants are in post stroke.
Primary Hypothesis will be changes in life-quality tests (EQ5-D, Barthel index, MRS test).
Functional tests show progress 6MWT, Berg balance test and postural control testing with posturography.
The results are compared and evaluated among the groups.
The expected hypothesis is that visual and acoustic stimulation produces a better physical state at higher intensity.
Patients were followed for 2 years and participated in a follow-up study every six months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Somogy
-
Kaposvár, Somogy, Hungary, 7400
- Dr. József Tollár
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• post stroke
Exclusion Criteria:
- Sever heart problem
- sever demeanor
- alcoholism
- drug problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Exercise+FU 2/week
Post stroke group that received 2 years of intensive therapy.
(2/week)
|
Neurorehabilitation - 2 years-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training.
(2/ week)
Neurorehabilitation - 2 years-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training.
(3/ week)
|
|
Active Comparator: Exercise+FU 3/week
Post stroke group that received 2 years of intensive therapy.
(3/week)
|
Neurorehabilitation - 2 years-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training.
(2/ week)
Neurorehabilitation - 2 years-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training.
(3/ week)
|
|
Active Comparator: physiotherapy
Post stroke group that received 2 years of traditional physiotherapy.
(3/week)
|
Physiotherapy 2-years-long (3/week)
|
|
No Intervention: Exercise+FU - controll
He did not receive treatment after 4 weeks of intensive care. it functions only as a control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
gait / functional test
Time Frame: 2 years, m (higher point is better)
|
6 minute walk test (m)
|
2 years, m (higher point is better)
|
|
balance test
Time Frame: 2 years, (41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk )
|
Berg Balance Test
|
2 years, (41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk )
|
|
postrural control test
Time Frame: 2 years, mm (2 year-long, the smaller the mm the better the result)
|
posturography
|
2 years, mm (2 year-long, the smaller the mm the better the result)
|
|
Quality of life measured by EQ5-D scale
Time Frame: 2 years, 0-5 scale (2 year-long, higher point is better)
|
questionnaire
|
2 years, 0-5 scale (2 year-long, higher point is better)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Actual)
September 1, 2020
Study Completion (Actual)
September 1, 2020
Study Registration Dates
First Submitted
October 6, 2020
First Submitted That Met QC Criteria
October 13, 2020
First Posted (Actual)
October 14, 2020
Study Record Updates
Last Update Posted (Actual)
October 14, 2020
Last Update Submitted That Met QC Criteria
October 13, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IKEB2020/06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.