Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy

Marsi Bionics

Status

Completed

Conditions

Cerebral Palsy

Treatments

Device: ATLAS 2030 exoskeleton

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05551364

A30-ATADES-CP

Details and patient eligibility

About

The main objective of this study is to assess the usability and efficacy of receiving therapy with the peaditric exoskeleton ATLAS 2030in children with gait impairment due to a cerebral palsy condition. It will be valued the impact of rehabilitation with the exoskeleton at the physical level on parameters such as joint range, spasticity, as well as the impact in quality of life. It is also assessed the impact at the level of functionality of the participants, through the administration of different functional assessment scales.

Enrollment

30 patients

Sex

All

Ages

3 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Medical authorization to for standing, gait training and weight bearing.
Maximum user weight of 35 kg.
Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 24cm to 33cm.
Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23cm to 32cm.
Hip width (between greater trochanteres) less than or equal to 35 cm.
Do not have an allergy to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
Ability to achieve the neutral position of the ankle, during the use of the device with or without technical aids.
Informed consent signed by legal guardians.
Confirmed diagnosis of cerebral palsy affecting the ability to walk.
Stable medical condition without modifications of the specific medication for the disease in the last 6 months, and other additional medication in the last month.
Patient in follow-up according to the normal standards recommended for his illness.

Exclusion criteria

More than 20º of hip flessum at the time of using the exoskeleton.
More than 20º of knee flessum at the time of using the exoskeleton.
Severe skin lesion on parts of the lower extremities that are in contact with the device.
Scheduled surgery (rachis, limbs) for the duration of the study or surgery performed (rachis, extremities) in the last 6 months.
History of fracture without trauma. History of bone fracture traumatic in lower extremities or pelvic girdle in the last 3 months.
Refusal of the patient or legal guardian to include the child in the study.
Skin problems (diseases, allergies, sensitivity ...) that prevent the use of exoskeleton accessories on the patient's skin.
Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.