Back to resultsEvaluation of the Exoskeleton ATLAS 2030 as Robot-assisted Physical Therapy to Children With Neuromuscular Diseases
Primary Purpose
Cerebral Palsy, SMA II, Neuromuscular Diseases
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exoskeleton rehabilitation
Sponsored by
About this trial
This is an interventional device feasibility trial for Cerebral Palsy focused on measuring Exoskeleton, robot-assisted, physical therapy, ATLAS
Eligibility Criteria
Inclusion Criteria:
- Maximum user weight of 35 kg
- Thigh length (distance from the greater trochanter to the lateral condyle of the tibia) from 24 cm to 40 cm.
- Leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23 to 39 cm.
- Pelvis width (between greater trochanters) from 24 to 35 cm.
- Ability to achieve ankle dorsiflexion to 90˚
- 20º or more hip flessum.
- 20º or more knee flessum.
- No allergies to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
- Informed consent signed by legal guardians.
- Confirmed diagnosis of cerebral palsy or neuromuscular disease affecting walking ability at early development stages
- Stable medical condition with no changes in disease-specific medication in the last 6 months, and additional medication in the last month.
- Patient being followed according to the recommended standards for his or her illness
- Ability to maintain, spontaneously or with a brace, the head and trunk while standing and walking.
- No need for daytime ventilation (have an oxygen saturation and PCO2 with normal ambient oxygen
- Score on the FAC scale between 1 and 4 points
- Not being able to walk without assistance
Exclusion Criteria:
- Patient's inability to follow simple instructions and/or communicate discomfort.
- Invasive or non-invasive daytime ventilation.
- Orthostatic hypotension.
- 20º or more hip flessum.
- 20º or more knee flessum
- Scoliosis with a Cobb angle of more than 25º that cannot wear a corset during the test.
- Severe skin injury to the lower extremities.
- Scheduled surgery (spine, extremities) during the period of the study or surgery performed (spine, extremities) in the last 6 months.
- History of fracture without trauma.
- History of traumatic bone fracture in lower limbs or pelvic girdle in the last 3 months
- Not receiving regular standing rehabilitation sessions.
- Absence of control of the head or trunk in an upright position without the possibility of wearing a corset during the use of the exoskeleton
- Refusal of the patient or legal guardian to include the child in the study.
- Skin problems (diseases, allergies, sensitivity ...) that prevent the use of exoskeleton accessories on the skin of patients.
Sites / Locations
- MarsiCare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Group
Arm Description
9 treatment sessions will be performed with the ATLAS2030 exoskeleton. The rehabilitation sessions last approximately 90 minutes. Two sessions are scheduled per week, for two weeks.
Outcomes
Primary Outcome Measures
Safety as number of serious device adverse events
Presence of a serious device adverse events where the participant or therapist is involved
Secondary Outcome Measures
Safety as presence of adverse events or adverse device events
Presence of a device adverse events where the participant or therapist is involved.
Exercises [measured as time per exercise in seconds]
Measured as time per event for at each therapy session.
Transfers [measured as time to carry out the transfers in seconds]
Measured as time to carry out the transfers
Acceptability [number of participants which discontinue the participation during the trial in relation with the included participants]
Measured as abandon ratio
Accessibility [number of potential participants in relation with the included participants]
Measured as relation between number of participants and number of potential participants which weren't recruited
Fall Prevalence [number of falls during the using of the device]
Number of falling events ocurred from the participant or therapist
Skin integrity [number of skin injuries related to the device]
skin integrity measured as the number of skin injuries
Pain [Wong-Baker FACES Pain Rating Scale]
Pain registered before and after the use of the device, by the participant and therapist. The options are from 1 to 6. A higher score means a worse outcome.
Fatigue [Borg Rating Scale of Perceived Exertion]
Fatigue registered before and after the use of the device, by the participant and therapist. Measured from 0 to 10, being 0 as fully rested and 10 very tired. A higher score means a worse outcome.
Spasticity [Modified Ashworth Scale]
Spasticity registered before and after the use of the device
Heart rate [sphygmomanometer]
Number of heart bets per minute
Physical evaluation [number of physical injuries detected]
Physical Evaluation as presence of tissue damage
Muscle Strength [measured with Hand Held Dynamometer in N]
Muscle Strength measured at hip, knee and ankle muscles
ROM [measured with goniometer]
Range of Movement
Functional Mobility [Functional Ambulation Category scale]
Functional Mobility with and without the device
System Usability [System Usability Scale]
Measurement of System's Usability measured by the therapist
User perception of the device [QUEST 2.0 and QUEST 2.1]
QUEST 2.0 will be assessed by the therapist, and QUEST 2.1 will be assessed by the participant
Distance covered walking [6MWT]
6MWT recorded using the device
Device malfunction [as number and type of device malfunction]
Any device malfunction will be recorded
Particpant's stability [Functional Reach Test]
Functional Reach Test
Systolic/Diastolic Pressure [sphygmomanometer]
Systolic Pressure and Diastolic Pressure measured with sphygmomanometer (measured in mmHg)
Breath Rate [number of breaths per minute]
Number of breaths per minute
SpO2 [pulse oximeter]
SpO2 measured as %
Full Information
NCT ID
NCT04837157
First Posted
November 3, 2020
Last Updated
April 6, 2021
Sponsor
MarsiBionics
Collaborators
Hospital Universitario La Paz
1. Study Identification
Unique Protocol Identification Number
NCT04837157
Brief Title
Evaluation of the Exoskeleton ATLAS 2030 as Robot-assisted Physical Therapy to Children With Neuromuscular Diseases
Official Title
Evaluation of the Safety of ATLAS 2030 in the Application of Robot-assisted Physical Therapy to Children With Neuromuscular Diseases Phase I
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MarsiBionics
Collaborators
Hospital Universitario La Paz
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
This study aims to evaluate the safety, usability and acceptability of a motorized mobility assistance exoskeleton. The protocol explores the use of the motorized device during static and dynamic rehabilitation sessions focused on walking and functional activities, with the expectation of evaluating the safety and usability of the device in the population studied. The protocol has been focused on defining how the device can be used appropriately in this population in a safe and effective manner by rehabilitation specialists. The study also aims to assess the safety of clinical staff who implement the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, SMA II, Neuromuscular Diseases
Keywords
Exoskeleton, robot-assisted, physical therapy, ATLAS
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
9 treatment sessions will be performed with the ATLAS2030 exoskeleton. The rehabilitation sessions last approximately 90 minutes. Two sessions are scheduled per week, for two weeks.
Intervention Type
Device
Intervention Name(s)
Exoskeleton rehabilitation
Other Intervention Name(s)
ATLAS2030, ATLAS, robot-assisted therapy
Intervention Description
The participants will perform physical therapy with the ATLSA2030 device, for 90 minutes per session.
Primary Outcome Measure Information:
Title
Safety as number of serious device adverse events
Description
Presence of a serious device adverse events where the participant or therapist is involved
Time Frame
after each use of exoskeleton, for 5 weeks
Secondary Outcome Measure Information:
Title
Safety as presence of adverse events or adverse device events
Description
Presence of a device adverse events where the participant or therapist is involved.
Time Frame
after each use of exoskeleton, for 5 weeks
Title
Exercises [measured as time per exercise in seconds]
Description
Measured as time per event for at each therapy session.
Time Frame
after each use of exoskeleton, for 5 weeks
Title
Transfers [measured as time to carry out the transfers in seconds]
Description
Measured as time to carry out the transfers
Time Frame
At each use of exoskeleton, for 5 weeks
Title
Acceptability [number of participants which discontinue the participation during the trial in relation with the included participants]
Description
Measured as abandon ratio
Time Frame
At the end of the study, at the 5th week
Title
Accessibility [number of potential participants in relation with the included participants]
Description
Measured as relation between number of participants and number of potential participants which weren't recruited
Time Frame
At the end of the study, at the 5th week
Title
Fall Prevalence [number of falls during the using of the device]
Description
Number of falling events ocurred from the participant or therapist
Time Frame
During the use of the device, for 5 weeks
Title
Skin integrity [number of skin injuries related to the device]
Description
skin integrity measured as the number of skin injuries
Time Frame
before and after each use of exoskeleton, for 5 weeks
Title
Pain [Wong-Baker FACES Pain Rating Scale]
Description
Pain registered before and after the use of the device, by the participant and therapist. The options are from 1 to 6. A higher score means a worse outcome.
Time Frame
Before and after the use of the device, during 5 weeks
Title
Fatigue [Borg Rating Scale of Perceived Exertion]
Description
Fatigue registered before and after the use of the device, by the participant and therapist. Measured from 0 to 10, being 0 as fully rested and 10 very tired. A higher score means a worse outcome.
Time Frame
Before and after the use of the device, during 5 weeks
Title
Spasticity [Modified Ashworth Scale]
Description
Spasticity registered before and after the use of the device
Time Frame
Before and after the use of the device, during 5 weeks
Title
Heart rate [sphygmomanometer]
Description
Number of heart bets per minute
Time Frame
Before and after the use of the device, during 5 weeks
Title
Physical evaluation [number of physical injuries detected]
Description
Physical Evaluation as presence of tissue damage
Time Frame
Before and after the use of the device, during 5 weeks
Title
Muscle Strength [measured with Hand Held Dynamometer in N]
Description
Muscle Strength measured at hip, knee and ankle muscles
Time Frame
At the first day, 3rd week and 5th week
Title
ROM [measured with goniometer]
Description
Range of Movement
Time Frame
At the first day, 3rd week and 5th week
Title
Functional Mobility [Functional Ambulation Category scale]
Description
Functional Mobility with and without the device
Time Frame
At the first day, 3rd week and 5th week
Title
System Usability [System Usability Scale]
Description
Measurement of System's Usability measured by the therapist
Time Frame
At the end of the study, 5th week
Title
User perception of the device [QUEST 2.0 and QUEST 2.1]
Description
QUEST 2.0 will be assessed by the therapist, and QUEST 2.1 will be assessed by the participant
Time Frame
At the end of the study, 5th week
Title
Distance covered walking [6MWT]
Description
6MWT recorded using the device
Time Frame
At the first day, 3rd week and 5th week
Title
Device malfunction [as number and type of device malfunction]
Description
Any device malfunction will be recorded
Time Frame
During the use of the device, for 5 weeks
Title
Particpant's stability [Functional Reach Test]
Description
Functional Reach Test
Time Frame
At the first day, 3rd week and 5th week
Title
Systolic/Diastolic Pressure [sphygmomanometer]
Description
Systolic Pressure and Diastolic Pressure measured with sphygmomanometer (measured in mmHg)
Time Frame
Before and after the use of the device, during 5 weeks
Title
Breath Rate [number of breaths per minute]
Description
Number of breaths per minute
Time Frame
Before and after the use of the device, during 5 weeks
Title
SpO2 [pulse oximeter]
Description
SpO2 measured as %
Time Frame
Before and after the use of the device, during 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Maximum user weight of 35 kg
Thigh length (distance from the greater trochanter to the lateral condyle of the tibia) from 24 cm to 40 cm.
Leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23 to 39 cm.
Pelvis width (between greater trochanters) from 24 to 35 cm.
Ability to achieve ankle dorsiflexion to 90˚
20º or more hip flessum.
20º or more knee flessum.
No allergies to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
Informed consent signed by legal guardians.
Confirmed diagnosis of cerebral palsy or neuromuscular disease affecting walking ability at early development stages
Stable medical condition with no changes in disease-specific medication in the last 6 months, and additional medication in the last month.
Patient being followed according to the recommended standards for his or her illness
Ability to maintain, spontaneously or with a brace, the head and trunk while standing and walking.
No need for daytime ventilation (have an oxygen saturation and PCO2 with normal ambient oxygen
Score on the FAC scale between 1 and 4 points
Not being able to walk without assistance
Exclusion Criteria:
Patient's inability to follow simple instructions and/or communicate discomfort.
Invasive or non-invasive daytime ventilation.
Orthostatic hypotension.
20º or more hip flessum.
20º or more knee flessum
Scoliosis with a Cobb angle of more than 25º that cannot wear a corset during the test.
Severe skin injury to the lower extremities.
Scheduled surgery (spine, extremities) during the period of the study or surgery performed (spine, extremities) in the last 6 months.
History of fracture without trauma.
History of traumatic bone fracture in lower limbs or pelvic girdle in the last 3 months
Not receiving regular standing rehabilitation sessions.
Absence of control of the head or trunk in an upright position without the possibility of wearing a corset during the use of the exoskeleton
Refusal of the patient or legal guardian to include the child in the study.
Skin problems (diseases, allergies, sensitivity ...) that prevent the use of exoskeleton accessories on the skin of patients.
Facility Information:
Facility Name
MarsiCare
City
Arganda Del Rey
State/Province
Madrid
ZIP/Postal Code
28500
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
35854321
Citation
Cumplido-Trasmonte C, Ramos-Rojas J, Delgado-Castillejo E, Garces-Castellote E, Puyuelo-Quintana G, Destarac-Eguizabal MA, Barquin-Santos E, Plaza-Flores A, Hernandez-Melero M, Gutierrez-Ayala A, Martinez-Moreno M, Garcia-Armada E. Effects of ATLAS 2030 gait exoskeleton on strength and range of motion in children with spinal muscular atrophy II: a case series. J Neuroeng Rehabil. 2022 Jul 19;19(1):75. doi: 10.1186/s12984-022-01055-x.
Results Reference
derived
Learn more about this trial
Evaluation of the Exoskeleton ATLAS 2030 as Robot-assisted Physical Therapy to Children With Neuromuscular Diseases
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