The evaluation of rehabilitation effects using exoskeleton EKSO GT in patients after stroke

Completed

• Conditions: hemiparesis; ambulation/gait limitations; mental health; quality of life; Stroke; Stroke - Ischaemic; Neurological - Other neurological disorders; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12616000148471
• Lead Sponsor: prof. Anna Mika

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-08
• Study Completion: 2017-12-31
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Subjects must be post stroke – 1st ischaemic stroke incident
Subjects must be able to fit into device and have joint motion to allow ambulation in device

Exclusion Criteria

Second or another stroke incident
Difference in lower limbs length bigger then 2 cm
Joint contractures of the hip, knee, or ankle that might limit normal ROM during ambulation
Medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe osteoporosis, or severe spasticity)
History of significant problems with skin breakdown or current skin breakdown that would prevent subject from wearing the device
Cognitive and/or communicative disability (e.g. due to brain injury). Patients must be able to follow directions and demonstrate learning capability
Pregnancy
Untreated deep vein thrombosis (DVT)
Weight above 100 kg
Height lower then 150 cm or above 190 cm

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in quality of ambulation assessed by surface electromyography with foot-switch sensors, [Baseline, after 4 weeks of treatment];Changes in functional abilities assessed by balance analysis -evaluated by baropodometric platform [Baseline and after 4 weeks of treatment];Changes in functional abilities assessed by muscles strength analysis - evaluated by isokinetic dynamometer[Baseline and after 4 weeks of treatment]