Comparison of Innovative Rehabilitation Treatments and Ex... | NCT05985889

Studies
Comparison of Innovative Rehabilitation Treatments and Examination of Their Effectiveness in Stroke Patients

NCT05985889

Sponsor

Somogy Megyei Kaposi Mór Teaching Hospital

Status

Unknown status

Last Update Posted

Aug 14, 2023Actual

Enrollment

75Actual

Phase

Not Applicable

Conditions

Stroke

Interventions

Robot
Fizio
EXE1
EXE2
EXE+ROB

Countries

Hungary

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 8, 2023Actual

Primary Completion Date

Aug 30, 2023Estimated

Completion Date

Aug 30, 2023Estimated

First Submitted Date

Aug 2, 2023

First Submission Date that Met QC Criteria

Aug 2, 2023

First Posted Date

Aug 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2023

Last Update Posted Date

Aug 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tollár József, Head of Department, Somogy Megyei Kaposi Mór Teaching HospitalPrincipal Investigator

Lead Sponsor

Somogy Megyei Kaposi Mór Teaching HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We perform a comparison of several groups. We would like to determine how robotic and virtual therapy is most effective in the treatment of stroke patients. We place great emphasis on walking speed, quality of life, coordination and changes in walking distance.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Robotic	Experimental	They performed training with a robot 15 times over 3 weeks.	Other: Robot
Fizio	Experimental	They receive physiotherapy treatment.	Other: Fizio
EXE1	Experimental	Virtual reality treatment is performed once a day.	Other: EXE1
EXE2	Experimental	Virtual reality treatment is performed twice a day.	Other: EXE2
EXE+ROB	Experimental	Virtual and robotic treatments are performed once a day.	Other: EXE+ROB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robot	Other	You have to walk with a robot mounted on your lower limb. To move, to change direction.	Robotic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mRS score		3 weeks (0-5 score, high score better)

Secondary Outcomes

Measure	Description	Time Frame
Barthel index score		3 weeks
Berg balance score		3 weeks (0-30, high score better)
6MWT

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

post stroke 6MWT : 120> minimum after stroke 3 days be a stroke patient first stroke hemiplegia

Exclusion Criteria:

multiple strokes, inability to stand and walk, cognitive function disorder does not reach 50 meters with a minimal walking aid Alcohol Sever heart problem sever demeanor alcoholism drug problems Drug

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Tollár József		Kaposvár	Somogy County	7400	Hungary

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided