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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000148471
Enrollment
60
Registered
2016-02-08
Start date
2015-05-11
Completion date
2017-11-30
Last updated
2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Limitations of independent walking after stroke and of functional status are serious problem for a growing group of patients. Restoration of walking abilities by various mechanical devices and locomotor training have been previously reported. Therapy for neurological recovery of walking may include locomotor training with the use of body weight supported treadmill training by either, a robotic training system or manual placement of the feet during the treadmill walking. The most technologically advanced devices for mechanical support of the gait are exoskeletons. An exoskeleton is a wearbale robot which support or, in some cases substitute for the user’s own movements. The aim of this study is the evaluation of the quality of ambulation and functional status of stroke survivors while using the robotic exoscelaton. This study will recruit individuals who have experienced an ischemic stroke. It will be focused on evaluation of the efficacy of new technology, a lower body exoskeleton EKSO GT with Variable Assist software extension(EKSO Bionics, Richmond, CA, USA), that allows ambulation of patients with various neurological disorders. The Variable Assist software feature allows the patients with hemiparesis to be trained only on the affected side, whilst the non-affected side works as a non-motorized support frame only. The other feature is the ability of adaptation of the level of force support given to the lower limbs by EKSO drives independently to each limb. Those two features might significantly improve the therapy outcomes made with the use of the EKSO system. Members of the research team will perform all of the evaluation listed in methods section on subjects, that have been qualified to EKSO training basing on inclusion and exclusion criteria provided by both Ekso Bionics (in terms of safe use of the device) and the lead researcher (to maintain the coherence of the research group). The Physical therapists conducting the training are certified EKSO Physical Therapist. The training of each evaluated individual will be made over the course of 4 weeks, 3-4 times a week. The subjects in control group will recieve a standard rehabilitation typical for stroke survivors. It wil include gait reeducation, neurorehabilitation with e.g PNF or Bobath methods. The rehabilitation will be administrated 3-4 times a week. Evaluation of the patients state will be made before the first training session and after last one.

Interventions

This study will recruit individuals who have experienced a stroke. It will be focused on evaluation of the efficacy of new technology, a lower body exoskeleton EKSO GT with Variable Assist software extension (EKSO Bionics, Richmond, CA, USA), that allows ambulation of patients with various neurological disorders. All measurement procedures will be performed by members of the research team on subjects, that have been qualified to EKSO training basing on inclusion and exclusion criteria provided b

This study will recruit individuals who have experienced a stroke. It will be focused on evaluation of the efficacy of new technology, a lower body exoskeleton EKSO GT with Variable Assist software extension (EKSO Bionics, Richmond, CA, USA), that allows ambulation of patients with various neurological disorders. All measurement procedures will be performed by members of the research team on subjects, that have been qualified to EKSO training basing on inclusion and exclusion criteria provided by both Ekso Bionics (in terms of safe use of the device) and the lead researcher (to maintain the coherence of the research group). The physical therapists conducting the training are certified EKSO Physical Therapist. Each training session will involve standing and walking in EKSO GT exosceleton. The intervention will be administrated on an individual one-on-one basis. The duration of each training session will depend on the patient capabilities to walking, but will not exceed 60 min each. The training of each evaluated individual will be made over the course of 4 weeks, 3-4 times a week. The frequency of sessions will be determined each time at the discretion of the treating therapist. Each training session in Ekso GT will be stored in exosceleton software and noted in patients personal medical documentation. Evaluation of the patients state will be made at baseline and after 4 weeks of treatment.

Sponsors

prof. Anna Mika
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026