Robot-Assisted Gait Therapy in the Subacute Phase of First Ischemic Stroke

September 19, 2023 updated by: University Hospital Ostrava
Robot-assisted gait training (RAGT) represents a modern concept of neurorehabilitation in stroke patients. This single-center randomized parallel-group neurorehabilitation trial with blinded primary outcome assessment is aimed at patients after the first-ever ischaemic stroke in the anterior or posterior cerebral circulation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main aim is to determine, whether the RAGT by using the Lokomat exoskeleton device (Hoccoma, Switzerland) plus the protocol-defined conventional rehabilitation versus conventional rehabilitation improves the gait of post-stroke patients after 6 months. Both groups are treated with the protocol-defined rehabilitation (ergotherapy and physiotherapy) for 60 min 5 times a week, a total of 15 times within 3 weeks (a total of 1200 min). The Lokowalkers group undergoes the RAGT using the Lokomat Pro Freed device for 20-50 minutes 5 times a week for a total of 15 times for 3 weeks (a total of 1800 minutes). The primary endpoint is the Functional Ambulation Category (FAC) after 3 months. Secondary endpoints include FAC (after 15th therapy), 10-meter walk test (10MWT) (after 15th therapy, after 3 months), Timed Up and Go Test (TUG) (after 15th therapy and after 3 months, 3-months modified Rankin Scale (mRS), and Berg Balance Scale (BBS, after 15th therapy, after 3 months).

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • Recruiting
        • University Hospital Ostrava
        • Contact:
        • Principal Investigator:
          • Ondrej Volny, MD,PhD,FESO
        • Sub-Investigator:
          • Iva Fiedorova, MSc.
        • Sub-Investigator:
          • Pavla Hanzlíkova, MD,PhD
        • Sub-Investigator:
          • Michal Bar, Assoc.Prof.,MD,PhD
        • Sub-Investigator:
          • Martin Roubec, MD,PhD
        • Sub-Investigator:
          • Radim Licenik, MD,PhD
        • Sub-Investigator:
          • Miloslav Klugar, Dr, PhD
        • Sub-Investigator:
          • Jitka Klugarova, Dr, PhD
        • Sub-Investigator:
          • Andrea Pokorna, prof.,Dr,PhD
        • Sub-Investigator:
          • Dana Salounova, prof.,Ing.,PhD
        • Sub-Investigator:
          • Pavel Elias, prof.,MD,PhD
        • Sub-Investigator:
          • Irina Chmelova, MD,PhD,MBA
        • Sub-Investigator:
          • Robert Mikulik, prof.,MD,PhD
        • Sub-Investigator:
          • Petra Brodova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • signed informed consent by the participant or legal representative
  • interval between stroke and first rehabilitation session < 6 weeks (study target within 2 weeks)
  • age > 18 years
  • early modified Rankin scale (mRS) 2 to 4 (pre-stroke mRS 0 to 1)
  • early FAC of 0 to 3 (pre-stroke FAC of 5)
  • standing ability with support up to 3 minutes and vertical tolerance > 15 minutes

Exclusion Criteria:

  • inability or refusal to sign an informed consent
  • history of stroke or another brain disease (tumour, multiple sclerosis, brain or spinal cord injury)
  • severe internal, oncological, or surgical comorbidity preventing long-term re-habilitation or causing chronic or progressive gait disorder
  • limited collaboration of any reason, moderate or severe dementia assessed by using the Montreal Cognitive Assessment (MoCA) scale
  • impaired skin integrity in the lower torso and limbs preventing the use of Lokomat device
  • limitations given by the Lokomat exoskeleton device (weight > 135 kg, thigh-length 23-35 cm, shank length 35-47cm)
  • limitations given by the leg/lower body exerciser (weight > 180 kg, height < 120 cm or > 200 cm, (sub)acute lower limb fractures, deep vein thrombosis, skin disintegration)
  • any contraindication to perform brain MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lokomat intervention
Patients randomized into the Lokomat arm will undergo therapy with Lokomat Pro FreeD for 20-50 minutes 5-times a week, a total of 15-times during the in-hospital stay in a total time of 1,800 minutes.
Procedure: Conventional rehabilitation
Patients will undergo conventional rehabilitation
Procedure: Lokomat intervention
Patients will undergo therapy with Lokomat Pro FreeD device intervention.
Experimental: Conventional rehabilitation
Patients in this arm will undergo conventional rehabilitation ((ergotherapy and physiotherapy) for 60 min 5 times a week, a total of 15 times within 3 weeks (a total of 1200 min)
Procedure: Conventional rehabilitation
Patients will undergo conventional rehabilitation
Procedure: Leg/lower body exerciser device intervention.
Patients will undergo leg/lower body exerciser device therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Ambulation Category (FAC) at 3 months
Time Frame: 3 months
Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value at 6-months will be observed.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects
Time Frame: up to 3 years
The number and character of adverse effects will be observed during the study.
up to 3 years
Early termination of the study
Time Frame: up to 3 years
The number of patients terminating the study early will be observed during the study.
up to 3 years
Reason/s for the termination
Time Frame: up to 3 years
The reason/s for the termination will be observed during the study.
up to 3 years
Study-related death or death unrelated to study
Time Frame: up to 3 years
The number of study-related deaths or deaths unrelated to study will be observed during the study.
up to 3 years
Functional Ambulation Category (FAC) (after 3 weeks)
Time Frame: 3 weeks
Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value after 3 weeks will be observed.
3 weeks
10-meter walk test (10-MWT) (after 3 weeks and 3 months)
Time Frame: up to 3 months
10-meter walk test will be performed after 3 weeks and 3 months
up to 3 months
Timed Up and Go Test (TUG) (after 3 weeks, after 3 months)
Time Frame: up to 3 months
Timed Up and Go Test (TUG) will be performed after 3 weeks, after 3 months
up to 3 months
3-months modified Rankin Scale (mRS)
Time Frame: up to 3 months
3-months modified Rankin Scale (mRS) assesses the functional independence and represents a standard outcome measure in post-stroke patients (range from 0 to 6).
up to 3 months
Berg Balance Scale (BBS, after 3 weeks, after 3 months)
Time Frame: up to 3 months
Berg Balance Scale (BBS) objectifies balance functions in 14 tasks. It assesses the risk of possible falls: 0-20 high, 21-40 medium, 41-56 low risk of falling.
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Collaborators

Masaryk University
VSB - Technical University of Ostrava

Investigators

  • Principal Investigator: Ondřej Volný, MD,PhD,FESO, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 26, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNO-Lokowalkers-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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