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Completed

NCT Number: NCT04587349

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

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.

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Key information

Conditions

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

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. József Tollár

Kaposvár, Somogy County, 7400, Hungary

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • post stroke

Exclusion criteria

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

Treatment and study plan

Neurorehabilitation

Other

Neurorehabilitation - 2 years-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (2/ week)

Physiotherapy

Other

Physiotherapy 2-years-long (3/week)

Primary outcomes

  1. gait / functional test

    Time frame: 2 years, m (higher point is better)

    6 minute walk test (m)

  2. balance test

    Time frame: 2 years, (41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk )

    Berg Balance Test

  3. postrural control test

    Time frame: 2 years, mm (2 year-long, the smaller the mm the better the result)

    posturography

  4. Quality of life measured by EQ5-D scale

    Time frame: 2 years, 0-5 scale (2 year-long, higher point is better)

    questionnaire

Sponsors and collaborators

Lead sponsor

Somogy Megyei Kaposi Mór Teaching Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2020
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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