Rehabilitative Effect of the Use of a Gait Exoskeleton in Patients With Neuromuscular Disease or Cerebral Palsy

NCT04813601 | Completed

• 1 other identifier: ATLAS2030CLI-I
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this multicentric study is to assess the rehabilitative effect derived from the use of the ATLAS exoskeleton in children with neuromuscular diseases or cerebral palsy and with a level of less than 3 or less in the Functional Ambulation Classification (FAC) as a consequence of their disease, as well as the assessment of other physical, functional and quality of life parameters of interest. For this purpose, the exoskeleton will be used as a rehabilitation and walking assistance tool. Before starting the study programme and if deemed necessary, a preliminary phase consisting of 1 to 3 sessions will be carried out during which the patient will be shown the exoskeleton for the first time and it will be considered whether any improvements to the different parts of the device or the software are necessary to increase the ergonomics and comfort of the patient.

Conditions

Neuromuscular Diseases; Cerebral Palsy; SMA II

Keywords

Gait Exoskeleton; Robotics; Children; ATLAS 2030; Neuromuscular disease; Cerebral Palsy; Rehabilitation

Outcome Measures

Primary Outcomes (18)

• Muscular balance

  Strength measured in Newtons with a Hand-Held Dinamometer for elbow flexion, neck lateralization, ankle plantarflexion and dorsiflexion, knee flexion and extension.

  1 month

• Expanded Hammersmith Functional Motor Scale

  Motor functionality measured for children with Spinal Muscular Atrophy

  3 months

• Gross Motor Function Measure 88 (GMFM-88)

  Motor functionality measured for children with Cerebral Palsy.

  3 months

• Respiratory rate

  Respiratory rate measured manually in breaths per minute using chronometer

  1 day

• Heart rate

  Measured in beats per minute using vital sign monitor

  1 day

• Oxigen Saturation

  Measured in %O2 using vital sign monitor

  1 day

• Blood preasure

  measured in mmHg with a sphyngomanometer

  1 day

• Respiratory functional parameters

  Measured by Spirometer (volumes measured in litres and pressures in mmHg)

  3 months

• Quality of life assessment

  Quality of life iof the children measured using the KINDL questionnaire.

  3 months

• Joint range of motion

  Range of motion in degrees of hip, knee and ankle movements using a manual goniometer.

  1 month

• Revised Upper Limb Module (RULM)

  Upper limb quality of movement using RULM scale for Spinal Muscular Atrophy children

  3 months

• Quality Upper Extremity Skill test (QUEST)

  Upper limb quality of movement using QUEST scale for cerebral palsy children

  3 months

• The Functional Independence Measure for Children (WeeFim)

  WeeFim scale for CP children.

  3 months

• Egen Klassifikation

  Functional ability measured using EK2 scale for SMA

  3 months

• Skin integrity

  Skin alterations assessing their localization, size (centimeters), redness and temperature increase.

  1 day

• Fatigue

  Patient fatigue measured by Borg fatigue scale for children ages

  1 day

• Pain assessment

  Patient pain measured by EVA faces scale for children ages

  1 day

• Peak Flow cough

  Measured in litres per minute using a Peak flowmeter

  1 week

Study Arms (1)

Robot Asissted Gait Training

EXPERIMENTAL

The rehabilitation sessions will be carried out by a physiotherapist trained in rehabilitation with the ATLAS 2030 exoskeleton and will also have the technical supervision of personnel specialised in the handling of the laboratory and the robotic device.

Device: ATLAS 2030

Interventions

ATLAS 2030 DEVICE

The participant will attend the laboratory every week, two days a week. The therapy will consist of the use of the exoskeleton for rehabilitative purposes. At the end of each three-month period, each patient's data will be monitored.

Also known as: Robot Asissted Gait Training

Robot Asissted Gait Training

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with neuromuscular disease or cerebral palsy who have gait disturbance or no gait.
• Children between 3 and 14 years of age.

You may not qualify if:

• Weight\> 35 kg
• Femoral length (from the axis of the hip joint in the sagittal plane to the axis of the knee joint in the same plane) \<23 cm or \>38 cm for size M and from 31 cm to 40 cm for size L
• Stem length (from the axis of the knee joint in the sagittal plane to the axis of the ankle joint in the same plane) \<23 or \>32 cm for size M and from or \>39 cm for size L
• Distance between great trochanters \<24 or \>35 cm for size M and \<25 cm or \>35 cm for size L
• Inability to understand simple commands, to cooperate actively in therapy, or inability to express basic needs
• Spasticity measured with the Modified Ashworth Scale greater than or equal to 3 in the lower limbs
• Scoliosis \> 25° without the possibility of wearing a brace
• Skin alteration where direct contact between the patient's skin and the exoskeleton is not recommended
• Limitation of passive range of motion at the knee or hip joint \> 20 degrees
• Osteoporosis that may induce a bone fracture when low intensity physical activity is performed
• Any other medical condition that may be a risk to the patient's safety and well-being in relation to low intensity physical exercise

Sponsors & Collaborators

• MarsiBionics: lead
• Hospital Universitario La Paz: collaborator
• National Research Council, Spain: collaborator

Study Sites (1)

MarsiCare

Arganda, Madrid, 28500, Spain

Location

MeSH Terms

Conditions

Neuromuscular Diseases; Cerebral Palsy; Spinal Muscular Atrophies of Childhood

Condition Hierarchy (Ancestors)

Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Muscular Atrophy, Spinal; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sandra Espinosa García, Medicine

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 24, 2021
• Study Start: March 9, 2020
• Primary Completion: March 9, 2021
• Study Completion: September 24, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 6 months after publication
• Access Criteria: Researchers who will asked for this data and with previous approval provided by reserach sponsor

Locations

ES (1)