NCT05947773

Brief Summary

We are conducting a three-group comparative study on stroke patients. The treatment is started in a subacute state and completed in the hospital. The essence of robot-assisted treatments is faster recovery and better learning to walk. The group will do a special walking exercise with a robot. The walking group does the same training, only without robotic assistance. The control group will receive physiotherapy treatments financed by the state. Control examination after 3 weeks.

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
45

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 9, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

July 9, 2023

Last Update Submit

August 2, 2023

Conditions

Keywords

roboticstrokerehabilitation

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale (mRS)

    stroke, diagnostic, quality of life

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

Secondary Outcomes (4)

  • Barthel Index for Activities of Daily Living (ADL)

    3 weeks

  • Berg Balance Scale

    3 weeks (0-30, high score better)

  • 10-m maximal walking speed

    3 weeks

  • 6MWT

    3 weeks

Study Arms (3)

Robotically treated patient

EXPERIMENTAL

They performed training with a robot 15 times over 3 weeks.

Other: Learning to walk with a robot

Walking training

EXPERIMENTAL

Walking exercises were performed without a robot.

Other: Walking group

Control group

EXPERIMENTAL

Physiotherapy treatment was carried out by the patients.

Other: Control group

Interventions

The patients completed a 1-hour learning to walk program using a soft exoskeleton. The protocol includes several difficult parts of the walk. (Walking protocol)

Also known as: ROB
Robotically treated patient

The walking protocol was performed without robotic assistance for 1 hour every day for 3 weeks.

Also known as: WALK
Walking training

The control group performed the physiotherapy treatment for 3 weeks.

Also known as: CON
Control group

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

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

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
Head of Department

Study Record Dates

First Submitted

July 9, 2023

First Posted

July 17, 2023

Study Start

July 9, 2023

Primary Completion

August 30, 2023

Study Completion

September 1, 2023

Last Updated

August 4, 2023

Record last verified: 2023-08

Locations