Spinal Muscular Atrophy Type IINCT05416034
Exoskeleton Impact on the Quality of Life on Patients With Spinal Muscular Atrophy
A study testing Use of the ATLAS 2025 exoskeleton at home in people with Spinal Muscular Atrophy Type II, run by MarsiBionics at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Spinal Muscular Atrophy Type II
- What is being tested?
- Use of the ATLAS 2025 exoskeleton at home
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2017to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients between 4 and 9 years old
- Patients with a confirmed diagnostic of Spinal Muscular Atrophy Type II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Impact of a Gait Exoskeleton on the Quality of Life of Patients With Spinal Muscular Atrophy
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.
- Conditions
- Spinal Muscular Atrophy Type II
- Being tested
- Use of the ATLAS 2025 exoskeleton at home
- Keywords
- exoskeleton, spinal muscular atrophy, care, quality of life, robotics
- Medical subject headings
- Spinal Muscular Atrophies of Childhood, Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the ATLAS 2025 exoskeleton at homeDevice
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..
| Study group | Role | What they receive |
|---|---|---|
| Use of the ATLAS 2030 exoskeleton at home | Experimental | 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 Receives: Device: Use of the ATLAS 2025 exoskeleton at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
Secondary outcomes (14)
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 month
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Dec 2017
- Primary completion30 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Muscular Atrophy Type IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- MarsiBionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416034
- Sponsor's protocol ID
- KINDER
- Status last verified
- Jun 2022
- First submitted
- 3 May 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of a Gait Exoskeleton on the Quality of Life of Patients With Spinal Muscular Atrophy
- ClinicalTrials.gov ID
- NCT05416034
- Acronym / sponsor ID
- KINDER
- Conditions
- Spinal Muscular Atrophy Type II
- Keywords
- exoskeleton, spinal muscular atrophy, care, quality of life, robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- MarsiBionicsIndustry (pharma, biotech, devices)
- Collaborators
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of the ATLAS 2030 exoskeleton at home | Experimental | Device: Use of the ATLAS 2025 exoskeleton at homeChildren 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 |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients between 4 and 9 years old
- Patients with a confirmed diagnostic of Spinal Muscular Atrophy Type II
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of the ATLAS 2025 exoskeleton at homeEach 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.. | Device | Use of the ATLAS 2030 exoskeleton at home |
Primary outcome
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
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.
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.
14 secondary outcomes
Upper limb Function
Time frame: 2 months
Number of Steps
Time frame: 2 months
Muscle Strength
Time frame: 2 months
Number of participants with abnormal vital signs
Time frame: 2 months
Respiratory rate (breaths/min)
Time frame: 2 months
Oxygen saturation
Time frame: 2 months
Self percieved fatigue
Time frame: 2 months
Motor Function
Time frame: 2 months
Duration of time walking in each session.
Time frame: 2 month
Blood pressure
Time frame: 2 months
Social behaviour
Time frame: 2 months
Exploration
Time frame: 2 months
Sense of agency
Time frame: 2 months
Emotional impact
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the ATLAS 2025 exoskeleton at home in people with Spinal Muscular Atrophy Type II, run by MarsiBionics at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenomenological Interviews (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.