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

Primary Purpose

Neuromuscular Diseases, Cerebral Palsy, SMA II

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ATLAS 2030
Sponsored by
MarsiBionics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromuscular Diseases focused on measuring Gait Exoskeleton, Robotics, Children, ATLAS 2030, Neuromuscular disease, Cerebral Palsy, Rehabilitation

Eligibility Criteria

3 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children with neuromuscular disease or cerebral palsy who have gait disturbance or no gait.
  • Children between 3 and 11 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

Sites / Locations

  • MarsiCare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robot Asissted Gait Training

Arm Description

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.

Outcomes

Primary Outcome Measures

Muscular balance
Strength measured in Newtons with a Hand-Held Dinamometer for elbow flexion, neck lateralization, ankle plantarflexion and dorsiflexion, knee flexion and extension.
Expanded Hammersmith Functional Motor Scale
Motor functionality measured for children with Spinal Muscular Atrophy
Gross Motor Function Measure 88 (GMFM-88)
Motor functionality measured for children with Cerebral Palsy.
Respiratory rate
Respiratory rate measured manually in breaths per minute using chronometer
Heart rate
Measured in beats per minute using vital sign monitor
Oxigen Saturation
Measured in %O2 using vital sign monitor
Blood preasure
measured in mmHg with a sphyngomanometer
Respiratory functional parameters
Measured by Spirometer (volumes measured in litres and pressures in mmHg)
Quality of life assessment
Quality of life iof the children measured using the KINDL questionnaire.
Joint range of motion
Range of motion in degrees of hip, knee and ankle movements using a manual goniometer.
Revised Upper Limb Module (RULM)
Upper limb quality of movement using RULM scale for Spinal Muscular Atrophy children
Quality Upper Extremity Skill test (QUEST)
Upper limb quality of movement using QUEST scale for cerebral palsy children
The Functional Independence Measure for Children (WeeFim)
WeeFim scale for CP children.
Egen Klassifikation
Functional ability measured using EK2 scale for SMA
Skin integrity
Skin alterations assessing their localization, size (centimeters), redness and temperature increase.
Fatigue
Patient fatigue measured by Borg fatigue scale for children ages
Pain assessment
Patient pain measured by EVA faces scale for children ages
Peak Flow cough
Measured in litres per minute using a Peak flowmeter

Secondary Outcome Measures

Full Information

First Posted
March 15, 2021
Last Updated
March 28, 2023
Sponsor
MarsiBionics
Collaborators
Hospital Universitario La Paz, National Research Council, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT04813601
Brief Title
Rehabilitative Effect of the Use of a Gait Exoskeleton in Patients With Neuromuscular Disease or Cerebral Palsy
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 9, 2020 (Actual)
Primary Completion Date
March 9, 2021 (Actual)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MarsiBionics
Collaborators
Hospital Universitario La Paz, National Research Council, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Diseases, Cerebral Palsy, SMA II
Keywords
Gait Exoskeleton, Robotics, Children, ATLAS 2030, Neuromuscular disease, Cerebral Palsy, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robot Asissted Gait Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ATLAS 2030
Other Intervention Name(s)
Robot Asissted Gait Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscular balance
Description
Strength measured in Newtons with a Hand-Held Dinamometer for elbow flexion, neck lateralization, ankle plantarflexion and dorsiflexion, knee flexion and extension.
Time Frame
1 month
Title
Expanded Hammersmith Functional Motor Scale
Description
Motor functionality measured for children with Spinal Muscular Atrophy
Time Frame
3 months
Title
Gross Motor Function Measure 88 (GMFM-88)
Description
Motor functionality measured for children with Cerebral Palsy.
Time Frame
3 months
Title
Respiratory rate
Description
Respiratory rate measured manually in breaths per minute using chronometer
Time Frame
1 day
Title
Heart rate
Description
Measured in beats per minute using vital sign monitor
Time Frame
1 day
Title
Oxigen Saturation
Description
Measured in %O2 using vital sign monitor
Time Frame
1 day
Title
Blood preasure
Description
measured in mmHg with a sphyngomanometer
Time Frame
1 day
Title
Respiratory functional parameters
Description
Measured by Spirometer (volumes measured in litres and pressures in mmHg)
Time Frame
3 months
Title
Quality of life assessment
Description
Quality of life iof the children measured using the KINDL questionnaire.
Time Frame
3 months
Title
Joint range of motion
Description
Range of motion in degrees of hip, knee and ankle movements using a manual goniometer.
Time Frame
1 month
Title
Revised Upper Limb Module (RULM)
Description
Upper limb quality of movement using RULM scale for Spinal Muscular Atrophy children
Time Frame
3 months
Title
Quality Upper Extremity Skill test (QUEST)
Description
Upper limb quality of movement using QUEST scale for cerebral palsy children
Time Frame
3 months
Title
The Functional Independence Measure for Children (WeeFim)
Description
WeeFim scale for CP children.
Time Frame
3 months
Title
Egen Klassifikation
Description
Functional ability measured using EK2 scale for SMA
Time Frame
3 months
Title
Skin integrity
Description
Skin alterations assessing their localization, size (centimeters), redness and temperature increase.
Time Frame
1 day
Title
Fatigue
Description
Patient fatigue measured by Borg fatigue scale for children ages
Time Frame
1 day
Title
Pain assessment
Description
Patient pain measured by EVA faces scale for children ages
Time Frame
1 day
Title
Peak Flow cough
Description
Measured in litres per minute using a Peak flowmeter
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Espinosa García, Medicine
Organizational Affiliation
Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
MarsiCare
City
Arganda Del Rey
State/Province
Madrid
ZIP/Postal Code
28500
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
Researchers who will asked for this data and with previous approval provided by reserach sponsor

Learn more about this trial

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

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