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Trial registered on ANZCTR


Registration number
ACTRN12616001284459
Ethics application status
Approved
Date submitted
18/08/2016
Date registered
12/09/2016
Date last updated
25/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The evaluation of rehabilitation effects using exoskeleton EKSO GT in patients with multiple sclerosis
Scientific title
The evaluation of rehabilitation effects using exoskeleton EKSO GT in patients with multiple sclerosis
Secondary ID [1] 289841 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
multiple sclerosis 299776 0
gait limitations 299777 0
postural control 299778 0
fatigue 299779 0
Condition category
Condition code
Neurological 299709 299709 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 299710 299710 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
People with multiple sclerosis will participate in the study.
The main objective of the study is to assess the efficacy of physiotherapy with the use of a lower body exoskeleton EKSO GT with Variable Assist software extension (EKSO Bionics, Richmond, CA, USA).
The assessment will be performed before program, after 3 weeks (a
period without training with EKSO GT), after 6 weeks (after training
with EKSO GT), after 12 weeks (6 weeks follow up from the end of
training). All measurement procedures will be performed by members of
the research team.
Each patient will participate in 15 training sessions with using EKSO GT. Each patient's training will last 3 weeks, 5 times a week. Standing and walking in EKSO GT exosceleton will be a part of the training session. Time of each training session is - from 45 to 60 minutes.
The duration of each training session will depend on the patient walking capabilities.
During the 3-week rehabilitation program using exoskeleton EKSO, patients will not use of any form of rehabilitation except exercises at home.
Physiotherapists who conduct the trainings, are certified EKSO
specialists. Each training session in Ekso GT will be stored in exoskeleton software
and recorded in patient's medical documentation.

Intervention code [1] 295525 0
Treatment: Devices
Intervention code [2] 295526 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299270 0
Changes in muscular strength assessed by isokinetic dynamometer during knee flexion-extension (Biodex System 4 Pro, Biodex Medical Systems Inc. USA)
Timepoint [1] 299270 0
Baseline, after 3 weeks (time without EKSO GT), after next 3 weeks (treatment with EKSO), follow up after next 6 weeks
Primary outcome [2] 299271 0
Changes in balance assessed by baropodometric platform (Zebris FDM-S, Zebris Medical GmbH, Germany). Stabilometric evaluation of quiet standing (eyes open/eyes closed), weight bearing during quiet standing
Timepoint [2] 299271 0
Baseline, after 3 weeks (time without EKSO GT), after next 3 weeks (treatment with EKSO), follow up after next 6 weeks
Primary outcome [3] 299272 0
Changes in gait speed assessed by timed 25-foot walk test (T25FWT)
Timepoint [3] 299272 0
Baseline, after 3 weeks (time without EKSO GT), after next 3 weeks (treatment with EKSO), follow up after next 6 weeks
Secondary outcome [1] 326700 0
Changes in muscular strength assessed by isokinetic dynamometer during shoulders internal and external rotation (Biodex System 4 Pro, Biodex Medical Systems Inc. USA)
Timepoint [1] 326700 0
Baseline, after 3 weeks (time without EKSO GT), after next 3 weeks (treatment with EKSO), follow up after next 6 weeks
Secondary outcome [2] 326701 0
Fatigue assessed by Fatigue Severity Scale (FSS)
Timepoint [2] 326701 0
Baseline, after 3 weeks (time without EKSO GT), after next 3 weeks (treatment with EKSO), follow up after next 6 weeks

Eligibility
Key inclusion criteria
Participants with Multiple Sclerosis,
Expanded Disability Status Scale (EDSS) 5,5-6,0
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Difference in lower limbs length bigger then 2 cm
Weight above 100 kg
Height lower then 150 cm or above 190 cm
History of significant problems with skin breakdown or current skin breakdown that would prevent subject from wearing the device
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8095 0
Poland
State/province [1] 8095 0
Podkarpackie

Funding & Sponsors
Funding source category [1] 294299 0
University
Name [1] 294299 0
University of Rzeszow
Address [1] 294299 0
University of Rzeszow
Aleja Rejtana 16c
35-959 Rzeszow
Country [1] 294299 0
Poland
Primary sponsor type
University
Name
University of Rzeszow
Address
University of Rzeszow
Aleja Rejtana 16c
35-959 Rzeszow
Country
Poland
Secondary sponsor category [1] 293136 0
None
Name [1] 293136 0
Address [1] 293136 0
Country [1] 293136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295704 0
The Ethical Committee of Regional Medical Chamber in Krakow
Ethics committee address [1] 295704 0
ul. Krupnicza 11a
31-123 Krakow
Ethics committee country [1] 295704 0
Poland
Date submitted for ethics approval [1] 295704 0
05/10/2015
Approval date [1] 295704 0
15/12/2015
Ethics approval number [1] 295704 0
173/KBL/OIL/2015

Summary
Brief summary
The study assesses the effects of the three-weeks gait training among people with MS using a exoskeleton EKSO GT. The study is a clinical trial with follow-up evaluation after 4 weeks. Study will qualify MS patients with an EDSS score of 5.5–6.0. Parameters to be tested are: Static balance - performed on barography platform, strength of the knee muscels ( extensors and flexors) and rotator cuff muscles, gait speed tested by T25-FW and fatigue level measured in the Fatigue Severity Scale. The expected result of the program is to increase muscle strength of the upper and lower extremities, improve static balance, increase walking speed and reduce fatigue level. The hypothesis of this study is to prove that, rehabilitation using exoskeleton EKSO GT significantly improves muscle strength, balance and walking speed in MS patients. The gait training program using Ekso GT lasted 45 to 60 minutes per day, 5 days per week for 3 weeks. The test was performed four times, the initial test, control examination after 3 weeks (control period without training with EKSO), third study after the completion of training with EKSO GT and the final examination after 4 weeks after completion of training. Throughout the test the participants will not use any other gait devices as treadmills, treadmills with partial body weight support (PBWS) such as Lokomat, Ekso GT or the like.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66330 0
Dr Mariusz Druzbicki
Address 66330 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 66330 0
Poland
Phone 66330 0
+48 178721921
Fax 66330 0
+48 178721930
Email 66330 0
mdruzb@ur.edu.pl
Contact person for public queries
Name 66331 0
Dr Mariusz Druzbicki
Address 66331 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 66331 0
Poland
Phone 66331 0
+48 178721920
Fax 66331 0
+48 17 8721930
Email 66331 0
mdruzb@ur.edu.pl
Contact person for scientific queries
Name 66332 0
Dr Mariusz Druzbicki
Address 66332 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 66332 0
Poland
Phone 66332 0
+48 178721920
Fax 66332 0
+48 178721930
Email 66332 0
mdruzb@ur.edu.pl

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary