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Trial record 1 of 1 for:    ATLAS 2025
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Exoskeleton Impact on the Quality of Life on Patients With Spinal Muscular Atrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05416034
Recruitment Status : Completed
First Posted : June 13, 2022
Last Update Posted : June 13, 2022
Sponsor:
Collaborator:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Information provided by (Responsible Party):
MarsiBionics

Brief Summary:
The purpose of this study is to evaluate the impact of the use of a pediatric exoskeleton on the quality of life of children, specifically in the psychological and care dimensions. Other objectives are to evaluate changes at the physical and functional level.

Condition or disease Intervention/treatment Phase
Spinal Muscular Atrophy Type II Device: Use of the ATLAS 2025 exoskeleton at home Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of the Impact of a Gait Exoskeleton on the Quality of Life of Patients With Spinal Muscular Atrophy
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : August 31, 2018


Arm Intervention/treatment
Experimental: Use of the ATLAS 2030 exoskeleton at home
Children with Spinal Muscular Atrophy Type II will received robot assisted gait therapy with the ATLAS 2030 exoskeleton at their homes 5 days a week during two months in 60 minutes sessions
Device: Use of the ATLAS 2025 exoskeleton at home
Each participant will use the ATLAS 2025 exoskeleton at their homes, 5 days a week during a period of two months, for walking with the device and performing motor activities in 60 minutes duration sessions..




Primary Outcome Measures :
  1. Phenomenological Interviews [ Time Frame: 2 months ]

    Assess the psychological impact of the experience on both children and the main care giver through phenomenological interviews.

    The phenomenological interview was an open interview evaluating how the participants lived the experience of using an exoskeleton at home


  2. Care impact [ Time Frame: 2 months ]

    To evaluate the impact of the experience in self-care of children by conducting nursing evaluations based on the Self-Care Theory developed by Dorothea Orem, before, during the use of the exoskeleton and at the end. To collect the data needed to complete the nursing assessment, structured nursing interviews were conducted with each child's primary caregiver.

    No scales are used to assess the care impact. A positive care impact will be considered if by using the exoskeleton any children or parents have an increase in any self-care agency.

    A negative care impact will be considered if by using the exoskeleton any self-care demand can not be satisfied by the self-care agency of any of the children or parents.


  3. Participant observation [ Time Frame: 2 months ]

    Assess the psychological impact of the experience on both children and the main care giver through participant observation.

    Participant observation was performed during exoskeleton use sessions in the children's homes. Data was taken by field notes of everything that happened during the session.



Secondary Outcome Measures :
  1. Upper limb Function [ Time Frame: 2 months ]
    Assessed by the Revised Upper Limb scale used to investigate the upper limb function of ambulatory and nonambulatory patients with Spinal Muscular Atrophy. The scale has 19 scorable items// Each item is scored from 0 to 2 0=Unable 1=Able, with modification 2=Able, no difficulty. The best possible final score is 0 and the worst final possible score is 38.

  2. Number of Steps [ Time Frame: 2 months ]
    Changes in the physical performance with the exoskeleton of the children over time by assessing the number of steps. This data collected directly from the device information.

  3. Muscle Strength [ Time Frame: 2 months ]
    Changes in muscle strength over time assessed by a hand held dynamometer at the begginig and at the end of the study. Every lower limb muscle is measured 3 times and the best result of the 3 is taken.

  4. Number of participants with abnormal vital signs [ Time Frame: 2 months ]
    The data obtained in vital signs before and after using the exoskeleton will be analysed by comparing the data with the Pediatric Emergency Assessment Recognition and Stabilization (PEARS) Vital Signs form the American Heart Association. Any abnormal value will be registered.

  5. Respiratory rate (breaths/min) [ Time Frame: 2 months ]
    The therapist took the respiratory rate by counting the number of breaths in one minute by observing the movement of the chest as the child breathed, before and after each session.

  6. Oxygen saturation [ Time Frame: 2 months ]
    Oxygen saturation and heart rate were measured with a suitable pediatric pulse oximeter using the PC-900PRO® (Creative Medical®, Shenzen, China) before and after each session.

  7. Self percieved fatigue [ Time Frame: 2 months ]
    Changes in self percieved fatigue before and after each session by using the OMNI (Omnibus) scale, a developmentally indexed category format that con- tains both pictorial and verbal descriptors positioned along a comparatively narrow numerical response range, i.e. category range 0 to 10. The best possible result is 0 and the worst is 10.

  8. Motor Function [ Time Frame: 2 months ]
    Assessed by the Hammersmith Functional Motor Scale for Spinal Muscular Atrophy. Designed with a 3 point scoring system: Score 2 = performs without modification/adaptation/compensation Score 1 = performs with modification/adaptation/compensation Score 0 = unable to perform Specific scoring criteria per item is outlined in detail in this manual. The best possible final score is 0 and the worst final possible score is 99.

  9. Duration of time walking in each session. [ Time Frame: 2 month ]
    Changes in the physical performance with the exoskeleton of the children over time by recording the duration of time walking in each session. This data collected directly from the device information.

  10. Blood pressure [ Time Frame: 2 months ]

    Systolic and Diastolic blood pressure (mmHg). Using the PC-900PRO® (Creative Medical®, China) before and after each session.

    Blood pressure is taken with the child sitting, always using the same arm for each child, with the correct cuff size and with the arm at heart level.


  11. Social behaviour [ Time Frame: 2 months ]

    Assessed by a semi-structured interview done to the child and the main care giver, and by participant observation which questions are focused on social behaviour aspects.

    No scales were used to assess the sense of agency.


  12. Exploration [ Time Frame: 2 months ]

    Assessed by a semi-structured interview done to the child and the main care giver, and by particpant observation which questions are focused on exploration aspects. .

    Participant observation was performed during exoskeleton use sessions in the children's homes. Data was taken by field notes of everything that happened during the session and the analysis focused on exploration aspects.

    No scales were used to assess exploration.


  13. Sense of agency [ Time Frame: 2 months ]

    Assessed by a semi-structured interview done to the child and the main care giver, and by participant observation which questions are focused on the sense of agency aspects.

    Participant observation was performed during exoskeleton use sessions in the children's homes. Data was taken by field notes of everything that happened during the session and the analysis focused on the sense of agency aspects.

    No scales were used to assess the sense of agency.


  14. Emotional impact [ Time Frame: 2 months ]

    Assessed by a semi-structured interview done to the child and the main care giver which questions are focused on the emotional aspects, and by participant observation.

    Participant observation was performed during exoskeleton use sessions in the children's homes. Data was taken by field notes of everything that happened during the session and the analysis focused on emotional impact aspects.

    No scales were used to assess the emotional impact.




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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between 4 and 9 years old
  • Patients with a confirmed diagnostic of Spinal Muscular Atrophy Type II

Exclusion Criteria:

  • Weight over 40 Kg
  • Hip-knee distance less than 22 cm or greater than 38cm
  • Knee-ankle distance less than 21 cm or greater than 37cm
  • Distance between trochanters less than 24 cm or greater than 40cm
  • Joint range limit greater than 20º

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05416034


Locations
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Spain
Hospital Ramón y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
MarsiBionics
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
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Responsible Party: MarsiBionics
ClinicalTrials.gov Identifier: NCT05416034    
Other Study ID Numbers: KINDER
First Posted: June 13, 2022    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MarsiBionics:
exoskeleton
spinal muscular atrophy
care
quality of life
robotics
Additional relevant MeSH terms:
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Muscular Atrophy
Muscular Atrophy, Spinal
Spinal Muscular Atrophies of Childhood
Atrophy
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases
Neuromuscular Diseases
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn