Evaluating Wearable Robotic Assistance on Gait
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
powered orthosis
Sponsored by
About this trial
This is an interventional device feasibility trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Age between 5 and 75 years old, inclusive.
- Either a healthy volunteer or a diagnosis of a neurologically-based walking disorder due to stroke, spinal cord injury, Parkinson's disease, or cerebral palsy.
- Must be able to understand and follow simple directions based on parent report and clinical observation during the history and physical examination.
- Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used.
- The ability to read and understand English.
- Able to walk at least 30 feet with or without a walking aid (GMFCS Level I-III for individuals with cerebral palsy)
Exclusion Criteria:
• Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis other than stroke, spinal cord injury, Parkinson's disease or cerebral palsy that would affect the ability to walk as directed for short periods of time.
Sites / Locations
- Northern Arizona University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Exoskeleton Assistance Higher Frequency
Exoskeleton Assistance Lower Frequency
Arm Description
Walking with exoskeleton assistance to make walking easier.
Walking with exoskeleton assistance to make walking easier.
Outcomes
Primary Outcome Measures
The metabolic energy required to walk
Metabolic energy required to walk will be measured using a portable metabolic measurement system (Cosmed K5). Units: J/kg/m
Walking speed
Walking speed measured over-ground or on a treadmill. Units: m/s
Muscle activity
Muscle activity during walking will be measured using electromyography electrodes. Units: mV
Lower-extremity joint angles
A motion capture system will be used to measure the posture of the body during walking. Units: Degrees
Lower extremity joint moments
A motion capture system and force plates will be used to measure the forces produced by the muscles of the body during walking. Units: Nm
Change in energy required to walk
We will compare the metabolic energy required to walk. Units: % change
Change in 6 minute walk test
We will compare the distance covered in 6 minutes of walking. Units: % change
Change in muscle activity profile
We will compare the muscle activity profile. Units: % change
Secondary Outcome Measures
Cadence
Number of steps per minute will be measured. Units: steps/min
Full Information
NCT ID
NCT04119063
First Posted
October 3, 2019
Last Updated
October 13, 2023
Sponsor
Northern Arizona University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT04119063
Brief Title
Evaluating Wearable Robotic Assistance on Gait
Official Title
Evaluating Wearable Robotic Assistance on Gait Mechanics and Energetics in Individuals With Neurological Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 8, 2019 (Actual)
Primary Completion Date
November 20, 2022 (Actual)
Study Completion Date
November 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern Arizona University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The overarching goal of this study is to improve mobility in individuals with movement disorders through advances in wearable assistance (i.e. powered orthoses).
Detailed Description
Design (Aim 1): To test the hypothesis for Aim 1, we will systematically adjust the magnitude of powered ankle assistance as ambulatory individuals with CP walk on over-ground walking at self-selected speeds, on a treadmill at set speeds, and on stair-stepping machine at a constant rate. The bi-directional ankle device will provide dorsi-flexion assistance if the participant has foot-drop. We will compare powered assistance to each participant's baseline walking condition (shod or AFOs); we will recruit a cohort where half of the participants walk with prescribed AFOs. We will measure three-dimensional motion capture, electromyography, and metabolic respiration data, and assess subject perception of exertion and benefit during the walking and stair trials for each level of assistance. Data collection will take place following a practice visit.
Design (Aim 2): To test the hypotheses for Aim 2, the same individuals with gait deficits from CP from Aim 1 will be randomly selected to complete 30 minutes of over-ground gait training with individually-tuned plantar-flexor assistance 4x/week for 1 week or 2x/week for 2 weeks. The magnitude of assistance during training will be set at the amount that maximized metabolic cost of transport during level walking in Aim 1 for each participant and kept constant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Feasibility assessment of powered orthosis assistance and resistance during walking.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exoskeleton Assistance Higher Frequency
Arm Type
Experimental
Arm Description
Walking with exoskeleton assistance to make walking easier.
Arm Title
Exoskeleton Assistance Lower Frequency
Arm Type
Experimental
Arm Description
Walking with exoskeleton assistance to make walking easier.
Intervention Type
Device
Intervention Name(s)
powered orthosis
Other Intervention Name(s)
exoskeleton
Intervention Description
Novel powered leg brace to provide assistance during walking.
Primary Outcome Measure Information:
Title
The metabolic energy required to walk
Description
Metabolic energy required to walk will be measured using a portable metabolic measurement system (Cosmed K5). Units: J/kg/m
Time Frame
Through study completion, an average of 8 weeks.
Title
Walking speed
Description
Walking speed measured over-ground or on a treadmill. Units: m/s
Time Frame
Through study completion, an average of 8 weeks.
Title
Muscle activity
Description
Muscle activity during walking will be measured using electromyography electrodes. Units: mV
Time Frame
Through study completion, an average of 8 weeks.
Title
Lower-extremity joint angles
Description
A motion capture system will be used to measure the posture of the body during walking. Units: Degrees
Time Frame
Through study completion, an average of 8 weeks.
Title
Lower extremity joint moments
Description
A motion capture system and force plates will be used to measure the forces produced by the muscles of the body during walking. Units: Nm
Time Frame
Through study completion, an average of 8 weeks.
Title
Change in energy required to walk
Description
We will compare the metabolic energy required to walk. Units: % change
Time Frame
Through study completion, an average of 8 weeks.
Title
Change in 6 minute walk test
Description
We will compare the distance covered in 6 minutes of walking. Units: % change
Time Frame
Through study completion, an average of 8 weeks.
Title
Change in muscle activity profile
Description
We will compare the muscle activity profile. Units: % change
Time Frame
Through study completion, an average of 8 weeks.
Secondary Outcome Measure Information:
Title
Cadence
Description
Number of steps per minute will be measured. Units: steps/min
Time Frame
Through study completion, an average of 8 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 5 and 35 years old, inclusive.
Either a healthy volunteer or a diagnosis of a neurologically-based walking disorder due to stroke, spinal cord injury, Parkinson's disease, or cerebral palsy.
Must be able to understand and follow simple directions based on parent report and clinical observation during the history and physical examination.
Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used.
The ability to read and understand English.
Able to walk at least 30 feet with or without a walking aid (GMFCS Level I-III for individuals with cerebral palsy)
Exclusion Criteria:
• Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis other than stroke, spinal cord injury, Parkinson's disease or cerebral palsy that would affect the ability to walk as directed for short periods of time.
Facility Information:
Facility Name
Northern Arizona University
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86011
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34758857
Citation
Orekhov G, Fang Y, Cuddeback CF, Lerner ZF. Usability and performance validation of an ultra-lightweight and versatile untethered robotic ankle exoskeleton. J Neuroeng Rehabil. 2021 Nov 10;18(1):163. doi: 10.1186/s12984-021-00954-9.
Results Reference
derived
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Evaluating Wearable Robotic Assistance on Gait
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