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

Not Applicable

Recruiting

• Conditions: Ischemic Stroke

• Registration Number: NCT04910217
• Lead Sponsor: University Hospital Ostrava

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).

Study Timeline

• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-06-02
• Study Start: 2022-05-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional Ambulation Category (FAC) at 3 months	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

Name	Time	Method
Adverse effects	up to 3 years	The number and character of adverse effects will be observed during the study.
Functional Ambulation Category (FAC) (after 3 weeks)	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)	up to 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)	up to 3 months	Timed Up and Go Test (TUG) will be performed after 3 weeks, after 3 months
3-months modified Rankin Scale (mRS)	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).
Early termination of the study	up to 3 years	The number of patients terminating the study early will be observed during the study.
Reason/s for the termination	up to 3 years	The reason/s for the termination will be observed during the study.
Berg Balance Scale (BBS, after 3 weeks, after 3 months)	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.
Study-related death or death unrelated to study	up to 3 years	The number of study-related deaths or deaths unrelated to study will be observed during the study.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia