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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Exergaming group
Physiotherapy
Exergaming group 2/day
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 - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • József Tollá

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Exergaming 1/day

physiotherapy

Exergaming 2/day

Arm Description

Post stroke group that received 4 weeks of intensive therapy. (1/day)

Post stroke group that received 4 weeks of traditional physiotherapy.

Post stroke group that received 4 weeks of intensive therapy. (2/day)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 1, 2018
Last Updated
April 27, 2020
Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03736200
Brief Title
Neuro-rehabilitation Training Effects on Motion and Quality of Life After Acute Stroke and Post Stroke
Official Title
Neuro-rehabilitation Training Effects on Motion and Quality of Life After Acute Stroke and Post Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (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
Yes

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.
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.

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
Exergaming 1/day
Arm Type
Active Comparator
Arm Description
Post stroke group that received 4 weeks of intensive therapy. (1/day)
Arm Title
physiotherapy
Arm Type
Active Comparator
Arm Description
Post stroke group that received 4 weeks of traditional physiotherapy.
Arm Title
Exergaming 2/day
Arm Type
Active Comparator
Arm Description
Post stroke group that received 4 weeks of intensive therapy. (2/day)
Intervention Type
Other
Intervention Name(s)
Exergaming group
Other Intervention Name(s)
EXE group
Intervention Description
Neurorehabilitation - 4-week-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (1/day)
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Physio group
Intervention Description
Physiotherapy 4-week-long.
Intervention Type
Other
Intervention Name(s)
Exergaming group 2/day
Other Intervention Name(s)
EXE2 group
Intervention Description
Neurorehabilitation - 4-week-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (2/day)
Primary Outcome Measure Information:
Title
Quality of life measured by Barthel index
Description
questionnaire
Time Frame
4 weeks
Title
gait / functional test
Description
6 minute walk test (m)
Time Frame
4 weeks
Title
balance test
Description
Berg balance test
Time Frame
4 weeks
Title
postrural control test
Description
posturography (mm)
Time Frame
4 weeks
Title
Quality of life measured by EQ5-D scale
Description
questionnaire
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: post stroke 6MWT : 120> minimum after stroke 2 weeks Exclusion Criteria: Sever heart problem sever demeanor alcoholism drug problems
Facility Information:
Facility Name
József Tollá
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary

12. IPD Sharing Statement

Citations:
PubMed Identifier
32861668
Citation
Tollar J, Nagy F, Csutoras B, Prontvai N, Nagy Z, Torok K, Blenyesi E, Vajda Z, Farkas D, Toth BE, Repa I, Moizs M, Sipos D, Kedves A, Kovacs A, Hortobagyi T. High Frequency and Intensity Rehabilitation in 641 Subacute Ischemic Stroke Patients. Arch Phys Med Rehabil. 2021 Jan;102(1):9-18. doi: 10.1016/j.apmr.2020.07.012. Epub 2020 Aug 27.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=stroke+virtual+reality
Description
Related Info

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

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