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

• Register: ANZCTR
• Last refreshed on: 28 June 2021
• Main ID: ACTRN12616000148471
• Date of registration: 08/02/2016
• Prospective Registration: No
• Primary sponsor: prof. Anna Mika
• Public title: The evaluation of rehabilitation effects using exoskeleton EKSO GT in patients after stroke
• Scientific title: The evaluation of rehabilitation effects using exoskeleton EKSO GT in patients after stroke
• Date of first enrolment: 11/05/2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000148471.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial;

Countries of recruitment

Poland

Contacts

• Name: Prof Anna Mika

• Name: Prof Anna Mika

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neurological - Other neurological disorders

hemiparesis;ambulation/gait limitations;mental health;quality of life;Stroke;
hemiparesis
ambulation/gait limitations
mental health
quality of life
Stroke

Stroke - Ischaemic

Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

Intervention(s)

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.

Primary Outcome(s)

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 muscles strength analysis - evaluated by isokinetic dynamometer[Baseline and after 4 weeks of treatment]

Changes in functional abilities assessed by balance analysis -evaluated by baropodometric platform [Baseline and after 4 weeks of treatment]

Secondary Outcome(s)

Change in bladder and bowel function assessed by medical staff evaluation- (composite secondary outcome)[Baseline, during every second training session and after 4 weeks of treatment]

Impact of treatment on Spasticity assessed by Modified Ashworth Scale (MAS)[Baseline, during every second training session and after 4 weeks of treatment]

Changes in gait quality assessed by surface electromyography with footswitch sensors. Analysis of muscle timing, recruitment over the gait phases, differences in activation between body sides and the changes over time
[Baseline and after 4 weeks of treatment]

Changes in muscular strength assessed by isokinetic dynamometer during knee flexion-extension[Baseline and after 4 weeks of treatment]

Changes in gait progression assessed by walking time in EKSO, training mode type in EKSO, level of assists in EKSO, step count (composite secondary outcome) [Baseline, during every second training session and after 4 weeks of treatment]

Quality of life assessed by questionnaire - Stroke Speci c Quality of Life Scale (SS-QOL) and SF-36[Baseline and after 4 weeks of treatment]

Cardiovascular effect of treatment assessed by heart rate and blood pressure measurements - evaluated by automatic sphygmomanometer[Baseline, during every second training session and after 4 weeks of treatment]

Changes in functional abilities assessed by Riverbed Mobility Index, Barthel Index and neurological evaluation (exteroceptive sensation – sensation of touch, vibration, squeeze, proprioception, mirror test)[Baseline and after 4 weeks of treatment]

Changes in balance and load distribution assessed by baropodometric platform. Stabilometric evaluation of quiet standing (eyes open/eyes closed), weight bearing during quiet standing and stand up from chair/sit down on chair tasks.
[Baseline and after 4 weeks of treatment]

Secondary ID(s)

None

Source(s) of Monetary Support

University of Physical Education in Krakow

Ethics review

Status: Approved
Approval date: 01/10/2014
Contact:

The Ethical Committee of Regional Medical Chamber in Krakow

Results

• Results available: Yes
• Date Posted: 22/06/2021
• Date Completed: 31/12/2017