Neuro-rehabilitation Training Effects on Motion and Quality of Life After Acute Stroke and Post Stroke

April 27, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

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

  • Hungary
    • Somogy
      • Kaposvár, Somogy, Hungary, 7400
        • József Tollá

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • post stroke
  • 6MWT : 120>
  • minimum after stroke 2 weeks

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Exergaming 1/day
Post stroke group that received 4 weeks of intensive therapy. (1/day)
Other: Exergaming group
Neurorehabilitation - 4-week-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (1/day)
Other Names:
  • EXE group
ACTIVE_COMPARATOR: physiotherapy
Post stroke group that received 4 weeks of traditional physiotherapy.
Other: Physiotherapy
Physiotherapy 4-week-long.
Other Names:
  • Physio group
ACTIVE_COMPARATOR: Exergaming 2/day
Post stroke group that received 4 weeks of intensive therapy. (2/day)
Other: Exergaming group 2/day
Neurorehabilitation - 4-week-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (2/day)
Other Names:
  • EXE2 group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life measured by Barthel index
Time Frame: 4 weeks
questionnaire
4 weeks
gait / functional test
Time Frame: 4 weeks
6 minute walk test (m)
4 weeks
balance test
Time Frame: 4 weeks
Berg balance test
4 weeks
postrural control test
Time Frame: 4 weeks
posturography (mm)
4 weeks
Quality of life measured by EQ5-D scale
Time Frame: 4 weeks
questionnaire
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Somogy Megyei Kaposi Mór Teaching Hospital

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.

General Publications

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)

November 1, 2019

Study Completion (ACTUAL)

November 1, 2019

Study Registration Dates

First Submitted

November 1, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (ACTUAL)

November 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IKEB008/2018

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.

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