NCT05985889

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

July 8, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

August 2, 2023

Last Update Submit

August 2, 2023

Conditions

Stroke

Keywords

roboticstrokerehabilitationvirtual rehabilitation

Outcome Measures

Primary Outcomes (1)

  • mRS score

    3 weeks (0-5 score, high score better)

Secondary Outcomes (4)

  • Barthel index score

    3 weeks

  • Berg balance score

    3 weeks (0-30, high score better)

  • 6MWT

    3 weeks

  • 10m gait speed

    3 weeks

Study Arms (5)

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

RobotOTHER

You have to walk with a robot mounted on your lower limb. To move, to change direction.

Also known as: ROB
Robotic
FizioOTHER

Patients do state-funded physical therapy.

Fizio
EXE1OTHER

Patients undergo intensive virtual reality therapy once a day.

EXE1
EXE2OTHER

Patients undergo intensive virtual reality therapy twice a day.

EXE2
EXE+ROBOTHER

The patients intensively performed 1 virtual reality therapy and 1 robotic therapy every day.

EXE+ROB

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Tollár József

Kaposvár, Somogy County, 7400, Hungary

Location

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 14, 2023

Study Start

July 8, 2023

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)