NCT04910217

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
PROCEDURE	Conventional rehabilitation	Patients will undergo conventional rehabilitation
PROCEDURE	Leg/lower body exerciser device intervention.	Patients will undergo leg/lower body exerciser device therapy.
PROCEDURE	Lokomat intervention	Patients will undergo therapy with Lokomat Pro FreeD device intervention.

Timeline

• Start date: 2022-05-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-06-02
• Last updated: 2023-09-21

Locations

1 site across 1 country: Czechia