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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03736200
Recruitment Status : Completed
First Posted : November 9, 2018
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Other: Exergaming group Other: Physiotherapy Other: Exergaming group 2/day Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Neuro-rehabilitation Training Effects on Motion and Quality of Life After Acute Stroke and Post Stroke
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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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 Name: EXE group
Active Comparator: physiotherapy
Post stroke group that received 4 weeks of traditional physiotherapy.
 Other: Physiotherapy
Physiotherapy 4-week-long.
Other Name: 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 Name: EXE2 group


Outcome Measures
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Primary Outcome Measures :
  1. Quality of life measured by Barthel index [ Time Frame: 4 weeks ]
    questionnaire

  2. gait / functional test [ Time Frame: 4 weeks ]
    6 minute walk test (m)

  3. balance test [ Time Frame: 4 weeks ]
    Berg balance test

  4. postrural control test [ Time Frame: 4 weeks ]
    posturography (mm)

  5. Quality of life measured by EQ5-D scale [ Time Frame: 4 weeks ]
    questionnaire


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Sever heart problem
  • sever demeanor
  • alcoholism
  • drug problems
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736200


Locations
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Hungary
József Tollá
Kaposvár, Somogy, Hungary, 7400
Sponsors and Collaborators
Somogy Megyei Kaposi Mór Teaching Hospital
More Information
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Additional Information:

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Responsible Party: Tollár József, Principal Investigator, Somogy Megyei Kaposi Mór Teaching Hospital
ClinicalTrials.gov Identifier: NCT03736200    
Other Study ID Numbers: IKEB008/2018
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital:
balance
movement
exergaming
 posture
quality of life
gait
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases