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NCT Number: NCT04813601

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

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.

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Key information

Conditions

Neuromuscular Diseases Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Motor Neuron Disease Muscular Atrophy, Spinal Nervous System Diseases Neurodegenerative Diseases SMA II Spinal Cord Diseases Spinal Muscular Atrophies of Childhood

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MarsiCare

Arganda, Madrid, 28500, Spain

About this study

The objectives of the study are:

  • Objective 1: To assess the safety and physical and physiological tolerance of the child to the activity performed with the exoskeleton in the rehabilitation sessions.
  • Objective 2:
  • To assess the safety of a progressive treatment algorithm to achieve the safe progression of patients throughout the therapy
  • To assess whether an improvement is achieved in parameters related to the physical rehabilitation of the patient using the exoskeleton, in respiratory capacity, self-perceived quality of life (physical and emotional well-being and self-esteem) as well as to assess the effectiveness of a psychological intervention to provide support in coping with the situation of using the device for the first time in those children who have not used it before.

The time period of the study will be as long as necessary to reach the desired number of participants, in this case 10 children (N=10). The participants will be patients affected by neuromuscular diseases or cerebral palsy and will be selected on the basis of the following inclusion/exclusion criteria:

Inclusion criteria

1. Children with neuromuscular disease or cerebral palsy who present gait disturbances or no gait disturbance. 2. Children between 3 and 11 years of age.

Exclussion criteria: not fulfil the usage criteria of the device.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Robot Asissted Gait Training

Primary outcomes

  1. Muscular balance

    Time frame: 1 month

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

  2. Expanded Hammersmith Functional Motor Scale

    Time frame: 3 months

    Motor functionality measured for children with Spinal Muscular Atrophy

  3. Gross Motor Function Measure 88 (GMFM-88)

    Time frame: 3 months

    Motor functionality measured for children with Cerebral Palsy.

  4. Respiratory rate

    Time frame: 1 day

    Respiratory rate measured manually in breaths per minute using chronometer

  5. Heart rate

    Time frame: 1 day

    Measured in beats per minute using vital sign monitor

  6. Oxigen Saturation

    Time frame: 1 day

    Measured in %O2 using vital sign monitor

  7. Blood preasure

    Time frame: 1 day

    measured in mmHg with a sphyngomanometer

  8. Respiratory functional parameters

    Time frame: 3 months

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

  9. Quality of life assessment

    Time frame: 3 months

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

  10. Joint range of motion

    Time frame: 1 month

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

  11. Revised Upper Limb Module (RULM)

    Time frame: 3 months

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

  12. Quality Upper Extremity Skill test (QUEST)

    Time frame: 3 months

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

  13. The Functional Independence Measure for Children (WeeFim)

    Time frame: 3 months

    WeeFim scale for CP children.

  14. Egen Klassifikation

    Time frame: 3 months

    Functional ability measured using EK2 scale for SMA

  15. Skin integrity

    Time frame: 1 day

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

  16. Fatigue

    Time frame: 1 day

    Patient fatigue measured by Borg fatigue scale for children ages

  17. Pain assessment

    Time frame: 1 day

    Patient pain measured by EVA faces scale for children ages

  18. Peak Flow cough

    Time frame: 1 week

    Measured in litres per minute using a Peak flowmeter

Sponsors and collaborators

Lead sponsor

MarsiBionics

Industry

Collaborators

  • Hospital Universitario La Paz
  • National Research Council, Spain

Registry information

Official study title

Estudio Piloto de Una Serie de Casos Para Evaluar el Efecto Rehabilitador Del Uso de un Exoesqueleto de Marcha en Pacientes Con patología Neuromuscular o parálisis Cerebral

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Mar 24, 2021
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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