Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-03 @ 8:09 AM
Study NCT ID:
NCT05416034
Status:
COMPLETED
Last Update Posted:
2022-06-13
First Post:
2022-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exoskeleton Impact on the Quality of Life on Patients With Spinal Muscular Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014897', 'term': 'Spinal Muscular Atrophies of Childhood'}, {'id': 'D009134', 'term': 'Muscular Atrophy, Spinal'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-10', 'studyFirstSubmitDate': '2022-05-03', 'studyFirstSubmitQcDate': '2022-06-10', 'lastUpdatePostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phenomenological Interviews', 'timeFrame': '2 months', 'description': 'Assess the psychological impact of the experience on both children and the main care giver through phenomenological interviews.\n\nThe phenomenological interview was an open interview evaluating how the participants lived the experience of using an exoskeleton at home'}, {'measure': 'Care impact', 'timeFrame': '2 months', '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.\n\nNo 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.\n\nA 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."}, {'measure': 'Participant observation', 'timeFrame': '2 months', 'description': "Assess the psychological impact of the experience on both children and the main care giver through participant observation.\n\nParticipant 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."}], 'secondaryOutcomes': [{'measure': 'Upper limb Function', 'timeFrame': '2 months', '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.'}, {'measure': 'Number of Steps', 'timeFrame': '2 months', '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.'}, {'measure': 'Muscle Strength', 'timeFrame': '2 months', '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.'}, {'measure': 'Number of participants with abnormal vital signs', 'timeFrame': '2 months', '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.'}, {'measure': 'Respiratory rate (breaths/min)', 'timeFrame': '2 months', '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.'}, {'measure': 'Oxygen saturation', 'timeFrame': '2 months', '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.'}, {'measure': 'Self percieved fatigue', 'timeFrame': '2 months', '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.'}, {'measure': 'Motor Function', 'timeFrame': '2 months', '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.'}, {'measure': 'Duration of time walking in each session.', 'timeFrame': '2 month', '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.'}, {'measure': 'Blood pressure', 'timeFrame': '2 months', 'description': 'Systolic and Diastolic blood pressure (mmHg). Using the PC-900PRO® (Creative Medical®, China) before and after each session.\n\nBlood 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.'}, {'measure': 'Social behaviour', 'timeFrame': '2 months', '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.\n\nNo scales were used to assess the sense of agency.'}, {'measure': 'Exploration', 'timeFrame': '2 months', '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. .\n\nParticipant 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.\n\nNo scales were used to assess exploration."}, {'measure': 'Sense of agency', 'timeFrame': '2 months', '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.\n\nParticipant 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.\n\nNo scales were used to assess the sense of agency."}, {'measure': 'Emotional impact', 'timeFrame': '2 months', '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.\n\nParticipant 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.\n\nNo scales were used to assess the emotional impact."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exoskeleton', 'spinal muscular atrophy', 'care', 'quality of life', 'robotics'], 'conditions': ['Spinal Muscular Atrophy Type II']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 4 and 9 years old\n* Patients with a confirmed diagnostic of Spinal Muscular Atrophy Type II\n\nExclusion Criteria:\n\n* Weight over 40 Kg\n* Hip-knee distance less than 22 cm or greater than 38cm\n* Knee-ankle distance less than 21 cm or greater than 37cm\n* Distance between trochanters less than 24 cm or greater than 40cm\n* Joint range limit greater than 20º'}, 'identificationModule': {'nctId': 'NCT05416034', 'briefTitle': 'Exoskeleton Impact on the Quality of Life on Patients With Spinal Muscular Atrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'MarsiBionics'}, 'officialTitle': 'Study of the Impact of a Gait Exoskeleton on the Quality of Life of Patients With Spinal Muscular Atrophy', 'orgStudyIdInfo': {'id': 'KINDER'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Use of the ATLAS 2030 exoskeleton at home', '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', 'interventionNames': ['Device: Use of the ATLAS 2025 exoskeleton at home']}], 'interventions': [{'name': 'Use of the ATLAS 2025 exoskeleton at home', 'type': 'DEVICE', '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..', 'armGroupLabels': ['Use of the ATLAS 2030 exoskeleton at home']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MarsiBionics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}