Exoskeleton Impact on the Quality of Life on Patients With Spinal Muscular Atrophy
Primary Purpose
Spinal Muscular Atrophy Type II
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Use of the ATLAS 2025 exoskeleton at home
Sponsored by
About this trial
This is an interventional basic science trial for Spinal Muscular Atrophy Type II focused on measuring exoskeleton, spinal muscular atrophy, care, quality of life, robotics
Eligibility 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
Sites / Locations
- Hospital Ramón y Cajal
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Use of the ATLAS 2030 exoskeleton at home
Arm Description
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
Outcomes
Primary Outcome Measures
Phenomenological Interviews
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
Care impact
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.
Participant observation
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
Upper limb Function
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.
Number of Steps
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.
Muscle Strength
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.
Number of participants with abnormal vital signs
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.
Respiratory rate (breaths/min)
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.
Oxygen saturation
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.
Self percieved fatigue
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.
Motor Function
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.
Duration of time walking in each session.
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.
Blood pressure
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.
Social behaviour
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.
Exploration
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.
Sense of agency
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.
Emotional impact
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.
Full Information
NCT ID
NCT05416034
First Posted
May 3, 2022
Last Updated
June 10, 2022
Sponsor
MarsiBionics
Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
1. Study Identification
Unique Protocol Identification Number
NCT05416034
Brief Title
Exoskeleton Impact on the Quality of Life on Patients With Spinal Muscular Atrophy
Official Title
Study of the Impact of a Gait Exoskeleton on the Quality of Life of Patients With Spinal Muscular Atrophy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MarsiBionics
Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Muscular Atrophy Type II
Keywords
exoskeleton, spinal muscular atrophy, care, quality of life, robotics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Use of the ATLAS 2030 exoskeleton at home
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Use of the ATLAS 2025 exoskeleton at home
Intervention Description
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 Measure Information:
Title
Phenomenological Interviews
Description
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
Time Frame
2 months
Title
Care impact
Description
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.
Time Frame
2 months
Title
Participant observation
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Upper limb Function
Description
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.
Time Frame
2 months
Title
Number of Steps
Description
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.
Time Frame
2 months
Title
Muscle Strength
Description
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.
Time Frame
2 months
Title
Number of participants with abnormal vital signs
Description
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.
Time Frame
2 months
Title
Respiratory rate (breaths/min)
Description
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.
Time Frame
2 months
Title
Oxygen saturation
Description
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.
Time Frame
2 months
Title
Self percieved fatigue
Description
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.
Time Frame
2 months
Title
Motor Function
Description
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.
Time Frame
2 months
Title
Duration of time walking in each session.
Description
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.
Time Frame
2 month
Title
Blood pressure
Description
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.
Time Frame
2 months
Title
Social behaviour
Description
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.
Time Frame
2 months
Title
Exploration
Description
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.
Time Frame
2 months
Title
Sense of agency
Description
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.
Time Frame
2 months
Title
Emotional impact
Description
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.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exoskeleton Impact on the Quality of Life on Patients With Spinal Muscular Atrophy
We'll reach out to this number within 24 hrs