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Trial registered on ANZCTR


Registration number
ACTRN12618001238268
Ethics application status
Approved
Date submitted
4/07/2018
Date registered
23/07/2018
Date last updated
1/07/2019
Date data sharing statement initially provided
1/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Introduction to the market of an innovative method of rehabilitation through verification of the effectiveness of the most modern diagnostic and therapeutic methods in patients with cerebral palsy
Scientific title
Six-week therapy using exoskeleton devices for patients with cerebral palsy with functional assessment using a three-dimensional gait analysis using the BTS Smart system and testing the equivalent responses in a standing position on the Zebris resistive treadmill
Secondary ID [1] 295434 0
None
Universal Trial Number (UTN)
U1111-1216-7331
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 308692 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307622 307622 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will include a group of patients with cerebral palsy diagnosed undergoing six-week therapy (5 times a week, 2 x 45 min) using the exoskeleton. Functional diagnostics will be performed before and after the therapy. It will include a three-dimensional gait analysis using the BTS Smart system from BTS Bioengineering and testing the equivalent reactions in a standing position on the Zebris baroresistive treadmill.
The pre-test result will determine the child's qualification for therapy with the use of exoskeleton.
The preliminary examination will include in addition:
• perinatal interview concerning the course of development and current treatment and improvement of the child (necessary to characterize the material),
• assessment of the current state of the child (topography of paresis, existing contractures, an indicative assessment of the locomotion of the child with the additional use of the GFMCS scale and assessment of spasticity using the modified Ashworth scale and Tardieu scale and the angle of stopping movement).
Administrators of the intervention will be physiotherapist.
EKSO GT is exoskeleton produced by the American company EKSO BIONICS is a portable bionic skeleton designed for the disabled. Exoskeleton is battery powered, movements are done by engines, what to replace lost neuromuscular functions. Exoskeleton conduct of functional rehabilitation, gait and exercises involving the transfer of body weight. The exoskeleton is applied to the patient's clothing.
The exoskeleton enables walking training using several different modes:
FirstStep ™ - the therapist initiates the movement using the button. The user proceeds from the movements of getting up and using the walker with the crutches even after the first session;
ProStep ™ - the user performs a step by transferring the weight of the body to his feet. Exoskieleton recognizes that the patient has reached the optimal position and takes the step;
ProStep Plus ™ - the steps are triggered by transferring the load by the patient and initiating the limb movement forward
Smart Assist mode allows patients to use the maximum possible strength to walk. Depending on the purpose of the training, the therapist can determine the specific value of the strength with which the exoskeleton should support the patient's movement or allow the device to automatically detect the force with which the patient interacts and adjust the strength with which it supports real-time movements. For example, a therapist can set a greater strength of support to focus on the quality of the gait, or less strength of support to focus on developing the movement initiating gait.
Intervention code [1] 301745 0
Rehabilitation
Intervention code [2] 301866 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306610 0
three-dimensional gait analysis with system BTS Smart
Timepoint [1] 306610 0
the assessment will be performed before and after 6 weeks of therapy (primary endpoint) and after 6 months from the end of therapy
Secondary outcome [1] 348997 0
evaluation of postural reactions (assessment of the center of pressure "COP") in a standing position on the Zebris baroresistive treadmill
Timepoint [1] 348997 0
the assessment will be performed before and after 6 weeks of therapy and after 6 months from the end of therapy
Secondary outcome [2] 348998 0
evaluation of the distribution of pressure forces during standing and walking on the Zebris baroresistive treadmill
Timepoint [2] 348998 0
the assessment will be performed before and after 6 weeks of therapy and after 6 months from the end of therapy
Secondary outcome [3] 349633 0
assessment of GMFCS scale- The Gross Motor Function Classification System is a 5 level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities
Timepoint [3] 349633 0
the assessment will be performed before and after 6 weeks of therapy and after 6 months from the end of therapy
Secondary outcome [4] 349635 0
assessment of Tardieu scale- This scale quantifies muscle spasticity by assessing the response of the muscle to stretch applied at specified velocities. With this scale lower and upper limbs groups of muscles will be assessed
Timepoint [4] 349635 0
the assessment will be performed before and after 6 weeks of therapy and after 6 months from the end of therapy
Secondary outcome [5] 349636 0
assessment of modified Ashworth scale - measures resistance during passive soft-tissue stretching. With this scale lower and upper limbs group of muscles will be assessed
Timepoint [5] 349636 0
the assessment will be performed before and after 6 weeks of therapy and after 6 months from the end of therapy
Secondary outcome [6] 349637 0
assessment of observed changes using a questionnaire designed specifically for this study
Timepoint [6] 349637 0
the assessment will be performed after 6 weeks of therapy and after 6 months from the end of therapy
Secondary outcome [7] 349786 0
assessment of parents' satisfaction using a questionnaire designed specifically for this study
Timepoint [7] 349786 0
the assessment will be performed after 6 weeks of therapy and after 6 months from the end of therapy

Eligibility
Key inclusion criteria
• confirmed cerebral palsy
• a minimum child height of 150 cm,
• the ability to walk or walk alone with help (the ability to walk at least 4-5 meters alone, with a balcony, with crutches or holding one hand by an accompanying person,
• no contraindications to carry out gait training on the part of the musculoskeletal system or other systems,
• a period of at least 6 months from the administration of botulinum toxin and the lack of surgical procedures performed within the lower limbs within the last 2 years,
• no dislocation or subluxation in the hip joints
• possibility of cooperation on the part of the child (compliance with instructions),
• written consent of the child's parents or guardians to participate in the research.
Minimum age
10 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• a child's height below 150 cm,
• a period of less than 6 months from the administration of botulinum toxin and an operation performed within the lower limbs within the last 2 years,
• dislocation or subluxation of the hip joints,
• contractures in the knee joints above 20 degrees,
• significant foot deformities,
• lack of cooperation on the part of the child,
• advanced osteoporosis making it impossible to stand up or be able to cause fractures during walking or standing training,
• active drug-resistant epilepsy,
• open skin lesions around the torso and / or lower limbs,
• cardiological contraindications for walking training,
• no consent for the child's participation in the project.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All parameters from the initial and final test will be placed in one database (in Excel) and then statistically developed using the Statistica program. In the statistical elaboration, it is planned to compare the final results with the initial ones and to look for relationships between parameters that may influence the obtained results.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/08/2018
Actual
3/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
6
Final
Recruitment outside Australia
Country [1] 10617 0
Poland
State/province [1] 10617 0

Funding & Sponsors
Funding source category [1] 300026 0
Commercial sector/Industry
Name [1] 300026 0
P.H.U. Technomex Sp. z o.o.
Country [1] 300026 0
Poland
Primary sponsor type
Commercial sector/Industry
Name
P.H.U. Technomex Sp. z o.o.
Address
ul. Szparagowa 15
44-141 Gliwice
Poland
Country
Poland
Secondary sponsor category [1] 299549 0
None
Name [1] 299549 0
Address [1] 299549 0
Country [1] 299549 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300873 0
bioethical commission at the University of Rzeszów
Ethics committee address [1] 300873 0
Ethics committee country [1] 300873 0
Poland
Date submitted for ethics approval [1] 300873 0
22/03/2018
Approval date [1] 300873 0
12/04/2018
Ethics approval number [1] 300873 0
2018/04/05

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85114 0
Dr Krzysztof Czupryna
Address 85114 0
Academy WSB in Dabrowa Górnicza
Zygmunta Cieplaka street 1c,
41-300 Dabrowa Górnicza
Poland
Country 85114 0
Poland
Phone 85114 0
+48600882310
Fax 85114 0
Email 85114 0
czupryna.krzysztof@gmail.com
Contact person for public queries
Name 85115 0
Krzysztof Czupryna
Address 85115 0
Academy WSB in Dabrowa Górnicza
Zygmunta Cieplaka street 1c,
41-300 Dabrowa Górnicza
Poland
Country 85115 0
Poland
Phone 85115 0
+48600882310
Fax 85115 0
Email 85115 0
czupryna.krzysztof@gmail.com
Contact person for scientific queries
Name 85116 0
Krzysztof Czupryna
Address 85116 0
Academy WSB in Dabrowa Górnicza
Zygmunta Cieplaka street 1c,
41-300 Dabrowa Górnicza
Poland
Country 85116 0
Poland
Phone 85116 0
+48600882310
Fax 85116 0
Email 85116 0
czupryna.krzysztof@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
the study is planned for publication in the form of a scientific elaboration together with statistical elaboration of the results, not as an individual participant data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.