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Follow-up Study of the Effectiveness of Virtual Reality Therapy in Patients With Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Neurorehabilitation
Neurorehabilitation
Physiotherapy
Sponsored by
Somogy Megyei Kaposi Mór Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring balance, movement, exergaming, posture, quality of life, gait

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• post stroke

Exclusion Criteria:

  • Sever heart problem
  • sever demeanor
  • alcoholism
  • drug problems

Sites / Locations

  • Dr. József Tollár

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Exercise+FU 2/week

Exercise+FU 3/week

physiotherapy

Exercise+FU - controll

Arm Description

Post stroke group that received 2 years of intensive therapy. (2/week)

Post stroke group that received 2 years of intensive therapy. (3/week)

Post stroke group that received 2 years of traditional physiotherapy. (3/week)

He did not receive treatment after 4 weeks of intensive care. it functions only as a control group.

Outcomes

Primary Outcome Measures

gait / functional test
6 minute walk test (m)
balance test
Berg Balance Test
postrural control test
posturography
Quality of life measured by EQ5-D scale
questionnaire

Secondary Outcome Measures

Full Information

First Posted
October 6, 2020
Last Updated
October 13, 2020
Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04587349
Brief Title
Follow-up Study of the Effectiveness of Virtual Reality Therapy in Patients With Stroke
Official Title
Follow-up Study of the Effectiveness of Virtual Reality Therapy in Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
balance, movement, exergaming, posture, quality of life, gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise+FU 2/week
Arm Type
Active Comparator
Arm Description
Post stroke group that received 2 years of intensive therapy. (2/week)
Arm Title
Exercise+FU 3/week
Arm Type
Active Comparator
Arm Description
Post stroke group that received 2 years of intensive therapy. (3/week)
Arm Title
physiotherapy
Arm Type
Active Comparator
Arm Description
Post stroke group that received 2 years of traditional physiotherapy. (3/week)
Arm Title
Exercise+FU - controll
Arm Type
No Intervention
Arm Description
He did not receive treatment after 4 weeks of intensive care. it functions only as a control group.
Intervention Type
Other
Intervention Name(s)
Neurorehabilitation
Intervention Description
Neurorehabilitation - 2 years-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (2/ week)
Intervention Type
Other
Intervention Name(s)
Neurorehabilitation
Intervention Description
Neurorehabilitation - 2 years-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (3/ week)
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Physiotherapy 2-years-long (3/week)
Primary Outcome Measure Information:
Title
gait / functional test
Description
6 minute walk test (m)
Time Frame
2 years, m (higher point is better)
Title
balance test
Description
Berg Balance Test
Time Frame
2 years, (41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk )
Title
postrural control test
Description
posturography
Time Frame
2 years, mm (2 year-long, the smaller the mm the better the result)
Title
Quality of life measured by EQ5-D scale
Description
questionnaire
Time Frame
2 years, 0-5 scale (2 year-long, higher point is better)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • post stroke Exclusion Criteria: Sever heart problem sever demeanor alcoholism drug problems
Facility Information:
Facility Name
Dr. József Tollár
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/?term=stroke+virtual+rehabilitation
Description
Related Info

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Follow-up Study of the Effectiveness of Virtual Reality Therapy in Patients With Stroke

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