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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001238268
Enrollment
6
Registered
2018-07-23
Start date
2019-06-03
Completion date
Unknown
Last updated
2019-07-15

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

Conditions

None listed

Brief summary

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 baroanniferous treadmill. The pre-test result will determine the child's qualification for therapy with the use of exoskeleton.

Interventions

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 wit

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.

Sponsors

P.H.U. Technomex Sp. z o.o.
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
10 Years to 25 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026