NCT04587349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

October 6, 2020

Last Update Submit

October 13, 2020

Conditions

Keywords

balancemovementexergamingposturequality of lifegait

Outcome Measures

Primary Outcomes (4)

  • gait / functional test

    6 minute walk test (m)

    2 years, m (higher point is better)

  • balance test

    Berg Balance Test

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

  • postrural control test

    posturography

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

  • Quality of life measured by EQ5-D scale

    questionnaire

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

Study Arms (4)

Exercise+FU 2/week

ACTIVE COMPARATOR

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

Other: Neurorehabilitation

Exercise+FU 3/week

ACTIVE COMPARATOR

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

Other: Neurorehabilitation

physiotherapy

ACTIVE COMPARATOR

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

Other: Physiotherapy

Exercise+FU - controll

NO INTERVENTION

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

Interventions

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

Exercise+FU 2/week

Physiotherapy 2-years-long (3/week)

physiotherapy

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • post stroke

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. József Tollár

Kaposvár, Somogy County, 7400, Hungary

Location

Related Links

MeSH Terms

Conditions

Stroke

Interventions

Neurological RehabilitationPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
7400 Kaposvár, Tallián Gy. u 20-32

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 14, 2020

Study Start

September 1, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations