Follow-up Study of the Effectiveness of Virtual Reality Therapy in Patients With Stroke
1 other identifier
interventional
2
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Sep 2018
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 6, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedOctober 14, 2020
October 1, 2020
2 years
October 6, 2020
October 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
gait / functional test
6 minute walk test (m)
2 years, m (higher point is better)
balance test
Berg Balance Test
2 years, (41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk )
postrural control test
posturography
2 years, mm (2 year-long, the smaller the mm the better the result)
Quality of life measured by EQ5-D scale
questionnaire
2 years, 0-5 scale (2 year-long, higher point is better)
Study Arms (4)
Exercise+FU 2/week
ACTIVE COMPARATORPost stroke group that received 2 years of intensive therapy. (2/week)
Exercise+FU 3/week
ACTIVE COMPARATORPost stroke group that received 2 years of intensive therapy. (3/week)
physiotherapy
ACTIVE COMPARATORPost stroke group that received 2 years of traditional physiotherapy. (3/week)
Exercise+FU - controll
NO INTERVENTIONHe did not receive treatment after 4 weeks of intensive care. it functions only as a control group.
Interventions
Neurorehabilitation - 2 years-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (2/ week)
Eligibility Criteria
You may qualify if:
- post stroke
You may not qualify if:
- Sever heart problem
- sever demeanor
- alcoholism
- drug problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. József Tollár
Kaposvár, Somogy County, 7400, Hungary
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- 7400 Kaposvár, Tallián Gy. u 20-32
Study Record Dates
First Submitted
October 6, 2020
First Posted
October 14, 2020
Study Start
September 1, 2018
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
October 14, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share