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

Primary Purpose

Ischemic Stroke

Status

Recruiting

Phase

Not Applicable

Locations

Czechia

Study Type

Interventional

Intervention

Conventional rehabilitation

Leg/lower body exerciser device intervention.

Lokomat intervention

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring gait, stroke, robotic rehabilitation, exoskeleton, neurorehabilitation, Lokomat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital OstravaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Lokomat intervention

Conventional rehabilitation

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

Functional Ambulation Category (FAC) at 3 months

Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value at 6-months will be observed.

Secondary Outcome Measures

Functional Ambulation Category (FAC) (after 3 weeks)

Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value after 3 weeks will be observed.

10-meter walk test (10-MWT) (after 3 weeks and 3 months)

10-meter walk test will be performed after 3 weeks and 3 months

Timed Up and Go Test (TUG) (after 3 weeks, after 3 months)

Timed Up and Go Test (TUG) will be performed after 3 weeks, after 3 months

3-months modified Rankin Scale (mRS)

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).

Berg Balance Scale (BBS, after 3 weeks, after 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.

Adverse effects

The number and character of adverse effects will be observed during the study.

Early termination of the study

The number of patients terminating the study early will be observed during the study.

Reason/s for the termination

The reason/s for the termination will be observed during the study.

Study-related death or death unrelated to study

The number of study-related deaths or deaths unrelated to study will be observed during the study.

Full Information

NCT ID

NCT04910217

First Posted

May 20, 2021

Last Updated

September 19, 2023

Sponsor

University Hospital Ostrava

Collaborators

Masaryk University, VSB - Technical University of Ostrava

1. Study Identification

Unique Protocol Identification Number

NCT04910217

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2022 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Ostrava

Collaborators

Masaryk University, VSB - Technical University of Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

gait, stroke, robotic rehabilitation, exoskeleton, neurorehabilitation, Lokomat

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Single-centre randomized parallel group neurorehabilitation trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lokomat intervention

Arm Type

Experimental

Arm Description

Arm Title

Conventional rehabilitation

Arm Type

Experimental

Arm Description

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)

Intervention Type

Procedure

Intervention Name(s)

Conventional rehabilitation

Intervention Description

Patients will undergo conventional rehabilitation

Intervention Type

Procedure

Intervention Name(s)

Leg/lower body exerciser device intervention.

Intervention Description

Patients will undergo leg/lower body exerciser device therapy.

Intervention Type

Procedure

Intervention Name(s)

Lokomat intervention

Intervention Description

Patients will undergo therapy with Lokomat Pro FreeD device intervention.

Primary Outcome Measure Information:

Title

Functional Ambulation Category (FAC) at 3 months

Description

Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value at 6-months will be observed.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Functional Ambulation Category (FAC) (after 3 weeks)

Description

Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value after 3 weeks will be observed.

Time Frame

3 weeks

Title

10-meter walk test (10-MWT) (after 3 weeks and 3 months)

Description

10-meter walk test will be performed after 3 weeks and 3 months

Time Frame

up to 3 months

Title

Timed Up and Go Test (TUG) (after 3 weeks, after 3 months)

Description

Timed Up and Go Test (TUG) will be performed after 3 weeks, after 3 months

Time Frame

up to 3 months

Title

3-months modified Rankin Scale (mRS)

Description

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).

Time Frame

up to 3 months

Title

Berg Balance Scale (BBS, after 3 weeks, after 3 months)

Description

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.

Time Frame

up to 3 months

Title

Adverse effects

Description

The number and character of adverse effects will be observed during the study.

Time Frame

up to 3 years

Title

Early termination of the study

Description

The number of patients terminating the study early will be observed during the study.

Time Frame

up to 3 years

Title

Reason/s for the termination

Description

The reason/s for the termination will be observed during the study.

Time Frame

up to 3 years

Title

Study-related death or death unrelated to study

Description

The number of study-related deaths or deaths unrelated to study will be observed during the study.

Time Frame

up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiří Hynčica

Phone

0042059737

Ext

2587

jiri.hyncica@fno.cz

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ondřej Volný, MD,PhD,FESO

Organizational Affiliation

University Hospital Ostrava

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ostrava

City

Ostrava

State/Province

Moravian-Silesian Region

ZIP/Postal Code

70852

Country

Czechia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiří Hynčica

Phone

0042059737

Ext

2587

jiri.hyncica@fno.cz

First Name & Middle Initial & Last Name & Degree

Ondrej Volny, MD,PhD,FESO

First Name & Middle Initial & Last Name & Degree

Iva Fiedorova, MSc.

First Name & Middle Initial & Last Name & Degree

Pavla Hanzlíkova, MD,PhD

First Name & Middle Initial & Last Name & Degree

Michal Bar, Assoc.Prof.,MD,PhD

First Name & Middle Initial & Last Name & Degree

Martin Roubec, MD,PhD

First Name & Middle Initial & Last Name & Degree

Radim Licenik, MD,PhD

First Name & Middle Initial & Last Name & Degree

Miloslav Klugar, Dr, PhD

First Name & Middle Initial & Last Name & Degree

Jitka Klugarova, Dr, PhD

First Name & Middle Initial & Last Name & Degree

Andrea Pokorna, prof.,Dr,PhD

First Name & Middle Initial & Last Name & Degree

Dana Salounova, prof.,Ing.,PhD

First Name & Middle Initial & Last Name & Degree

Pavel Elias, prof.,MD,PhD

First Name & Middle Initial & Last Name & Degree

Irina Chmelova, MD,PhD,MBA

First Name & Middle Initial & Last Name & Degree

Robert Mikulik, prof.,MD,PhD

First Name & Middle Initial & Last Name & Degree

Petra Brodova

12. IPD Sharing Statement

Plan to Share IPD

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

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