Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000148471
Ethics application status
Approved
Date submitted
5/01/2016
Date registered
8/02/2016
Date last updated
22/06/2021
Date data sharing statement initially provided
22/06/2021
Date results information initially provided
22/06/2021
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 288229 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hemiparesis 297148 0
ambulation/gait limitations 297149 0
mental health 297150 0
quality of life 297151 0
Stroke 297487 0
Condition category
Condition code
Stroke 297374 297374 0 0
Ischaemic
Neurological 297674 297674 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 297675 297675 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293519 0
Treatment: Devices
Intervention code [2] 293520 0
Rehabilitation
Comparator / control treatment
The subjects in control group will recieve a standard rehabilitation typical for stroke survivors. It will 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 at baseline and after 4 weeks of treatment.
Control group
Active

Outcomes
Primary outcome [1] 296925 0
Changes in quality of ambulation assessed by surface electromyography with foot-switch sensors,
Timepoint [1] 296925 0
Baseline, after 4 weeks of treatment
Primary outcome [2] 296926 0
Changes in functional abilities assessed by balance analysis -evaluated by baropodometric platform
Timepoint [2] 296926 0
Baseline and after 4 weeks of treatment
Primary outcome [3] 297215 0
Changes in functional abilities assessed by muscles strength analysis - evaluated by isokinetic dynamometer
Timepoint [3] 297215 0
Baseline and after 4 weeks of treatment
Secondary outcome [1] 319712 0
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)
Timepoint [1] 319712 0
Baseline, during every second training session and after 4 weeks of treatment
Secondary outcome [2] 319713 0
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
Timepoint [2] 319713 0
Baseline and after 4 weeks of treatment
Secondary outcome [3] 319714 0
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.
Timepoint [3] 319714 0
Baseline and after 4 weeks of treatment
Secondary outcome [4] 319715 0
Changes in muscular strength assessed by isokinetic dynamometer during knee flexion-extension
Timepoint [4] 319715 0
Baseline and after 4 weeks of treatment
Secondary outcome [5] 319716 0
Cardiovascular effect of treatment assessed by heart rate and blood pressure measurements - evaluated by automatic sphygmomanometer
Timepoint [5] 319716 0
Baseline, during every second training session and after 4 weeks of treatment
Secondary outcome [6] 319717 0
Impact of treatment on Spasticity assessed by Modified Ashworth Scale (MAS)
Timepoint [6] 319717 0
Baseline, during every second training session and after 4 weeks of treatment
Secondary outcome [7] 319718 0
Change in bladder and bowel function assessed by medical staff evaluation- (composite secondary outcome)
Timepoint [7] 319718 0
Baseline, during every second training session and after 4 weeks of treatment
Secondary outcome [8] 319719 0
Changes in functional abilities assessed by Riverbed Mobility Index, Barthel Index and neurological evaluation (exteroceptive sensation – sensation of touch, vibration, squeeze, proprioception, mirror test)
Timepoint [8] 319719 0
Baseline and after 4 weeks of treatment
Secondary outcome [9] 319720 0
Quality of life assessed by questionnaire - Stroke Speci c Quality of Life Scale (SS-QOL) and SF-36
Timepoint [9] 319720 0
Baseline and after 4 weeks of treatment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/05/2015
Actual
11/05/2015
Date of last participant enrolment
Anticipated
30/12/2016
Actual
30/11/2017
Date of last data collection
Anticipated
Actual
31/12/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 7490 0
Poland
State/province [1] 7490 0

Funding & Sponsors
Funding source category [1] 292611 0
University
Name [1] 292611 0
University of Physical Education in Krakow
Country [1] 292611 0
Poland
Primary sponsor type
Individual
Name
prof. Anna Mika
Address
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 291332 0
None
Name [1] 291332 0
None
Address [1] 291332 0
None
Country [1] 291332 0
Other collaborator category [1] 278751 0
Other
Name [1] 278751 0
Institute of Physical Education, State Higher Vocational School in Nowy Sacz, Poland
Address [1] 278751 0
ul Kosciuszki 2
33-300 Nowy Sacz
Country [1] 278751 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294092 0
The Ethical Committee of Regional Medical Chamber in Krakow
Ethics committee address [1] 294092 0
ul. Krupnicza 11a
31-123 Krakow
Ethics committee country [1] 294092 0
Poland
Date submitted for ethics approval [1] 294092 0
Approval date [1] 294092 0
01/10/2014
Ethics approval number [1] 294092 0
77/KBL/OLI/2014

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60326 0
Prof Anna Mika
Address 60326 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 60326 0
Poland
Phone 60326 0
+48 12 6831134
Fax 60326 0
Email 60326 0
anna.mika@awf.krakow.pl
Contact person for public queries
Name 60327 0
Prof Anna Mika
Address 60327 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 60327 0
Poland
Phone 60327 0
+48 12 6831134
Fax 60327 0
Email 60327 0
anna.mika@awf.krakow.pl
Contact person for scientific queries
Name 60328 0
Prof Anna Mika
Address 60328 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 60328 0
Poland
Phone 60328 0
+48 12 6831134
Fax 60328 0
Email 60328 0
anna.mika@awf.krakow.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Rojek A, Mika A, Oleksy L, Stolarczyk A, Kielnar R... [More Details]

Documents added automatically
No additional documents have been identified.