NCT05300867

Brief Summary

Storke results in severe deterioration in quality of life and exercise. Severe disorders need to be treated as soon as possible and they need to be rehabilitated quickly in order for motor functions to develop properly. In the acute / subacute phase, patients are given robotic treatment. In addition to the study of mtoros functions, the study of gait and codination is the primary result. Patients treated with soft exoskeleton receive 15 treatments and movement testing is performed continuously. Members of the control group receive standard rehabilitation therapy. After 3 weeks, both groups will participate in a control study and then in a repeat control study at week 6. Our main goal is to compare the results and determine the efficiency of the robotic device.

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

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 19, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

March 19, 2022

Last Update Submit

August 2, 2023

Conditions

Keywords

balancesoft exoskeletonwalkrobotic

Outcome Measures

Primary Outcomes (5)

  • Qualiti of life measured by Barthel index

    quetionnaire

    3 weeks

  • gait/functional test

    6 minute walk test (m)

    3 weeks

  • gait/functional test

    10 m walk test (m/s)

    3 weeks

  • balance test

    Berg balance test

    3 weeks

  • postural control test

    posturography

    3 weeks

Study Arms (2)

Robotic

ACTIVE COMPARATOR
Other: Neurorehabilitation

Controll

ACTIVE COMPARATOR
Other: Physiotherapy

Interventions

Neurorehabilitation with soft exsoskeleton robotic 3-week-long

Also known as: Rob group
Robotic

Physiotherapy 3-week-long

Also known as: Controll groum
Controll

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • post stroke 6MWT : 120\> minimum after stroke 3 days

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. Tollár József

Kaposvár, Somogy County, 7400, Hungary

Location

Related Links

MeSH Terms

Conditions

StrokeIschemic 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
Dr. József Tollár, Head of Neurorehabilitation ,7400 Kaposvár, Tallián Gy. u 20-32

Study Record Dates

First Submitted

March 19, 2022

First Posted

March 29, 2022

Study Start

April 1, 2022

Primary Completion

September 1, 2022

Study Completion

November 1, 2022

Last Updated

August 3, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations