Exoskeleton Impact on the Quality of Life on Patients With Spinal Muscular Atrophy

Spinal Muscular Atrophy Type II Clinical Trial

Official title:

Study of the Impact of a Gait Exoskeleton on the Quality of Life of Patients With Spinal Muscular Atrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05416034
• Other study ID #: KINDER
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: June 2022
• Source: MarsiBionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 31, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Spinal Muscular Atrophy Type II

Intervention

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..

Locations

Country	Name	City	State
Spain	Hospital Ramón y Cajal	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
MarsiBionics	Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 months
Primary	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.	2 months
Primary	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.	2 months
Secondary	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 modi?cation 2=Able, no dif?culty. The best possible final score is 0 and the worst final possible score is 38.	2 months
Secondary	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.	2 months
Secondary	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.	2 months
Secondary	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.	2 months
Secondary	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.	2 months
Secondary	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.	2 months
Secondary	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.	2 months
Secondary	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.	2 months
Secondary	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.	2 month
Secondary	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.	2 months
Secondary	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.	2 months
Secondary	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.	2 months
Secondary	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.	2 months
Secondary	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.	2 months