Strategic Research Program 17 (VUB Funding)
Primary Purpose
Prosthesis User, Amputation; Traumatic, Limb, Lower
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
AMPfoot 4.0
No intervention
Sponsored by
About this trial
This is an interventional other trial for Prosthesis User focused on measuring AMPfoot, Prosthetics, gait, electro-encephalography, dual-task walking
Eligibility Criteria
Inclusion Criteria:
- Unilateral transfemoral amputees
- Unilateral transtibial amputees
- Able-bodied individuals
Exclusion Criteria:
- Children
- Functional k-level lower than 4 (Amputee has the ability for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress or energy levels)
Sites / Locations
- Vrije Universiteit Brussel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Able-bodied individuals
Transtibial amputee
Transfemoral amputee
Arm Description
Outcomes
Primary Outcome Measures
Reaction time (in ms) of responses during go - no go cognitive task
Time between visual stimulus and motor response (pushing button)
Accuracy (in percentage) of correct responses during go - no go cognitive task
Accuracy of motor responses to visual stimuli
EEG extracted brain signals, i.e. motor-related cortical potentials
Non-invasive electro-encephalography was used to determine electro-cortical potentials and brain sources of these potentials
Secondary Outcome Measures
Full Information
NCT ID
NCT03498872
First Posted
April 3, 2018
Last Updated
April 13, 2018
Sponsor
Vrije Universiteit Brussel
1. Study Identification
Unique Protocol Identification Number
NCT03498872
Brief Title
Strategic Research Program 17 (VUB Funding)
Official Title
Exercise and the Brain in Health & Disease: The Added Value of Human-Centered Robotics
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
December 15, 2016 (Actual)
Study Completion Date
December 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
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
Objectives: The main objectives are to determine neural dynamics during gait using electro-encephalography as well as brain sources and to investigate the attentional demand during walking in able-bodied individuals, and individuals with an amputation.
Materials & Methods: 6 able-bodied individuals conducted one experimental trial, and 6 unilateral transtibial and 6 unilateral transfemoral amputees performed 2 experimental trials; the first with the current and the second with a novel powered transtibial prosthesis, i.e. the Ankle Mimicking Prosthetic foot 4.0. Each experimental trial comprised 2 walking tasks; 6 and 2min treadmill walking at normal speed interspersed by 5min of rest. During 6min walking the sustained attention to response (go-no go) task, with measures reaction time and accuracy, was performed. Electro-encephalographic (EEG) data were gathered when subjects walked 2min. Motor-related cortical potentials and brain activity during gait are extracted using EEG.
Detailed Description
Detailed description of the novel device:
The device mainly distinguishes itself from commercial prostheses thanks to its new type of actuation providing a compact and energy efficient solution to the challenge of ankle-foot actuation. This new actuation method consists of using springs, a servo motor and a locking mechanism, coupled with a sensory network providing intelligence to the robotic device. The AMPfoot 4.0 design is also based on previous research conducted on the AMP-Foot 2. However, it is important to note that in contrast with its preceding designs, the AMP-Foot 4.0 does not provide active propulsion at push-off.
During walking, the AMP-Foot 4.0 working principle is divided into two main logic sequences, i.e. the stance and the swing phase. These two phases are detected by analyzing gyroscope and acceleration measurements from an Inertial Measurement Unit chip. During the stance phase, the ankle performs a dorsi-flexing movement while a plantar-flexing torque is applied at the ankle. The person's gravitational potential energy is stored into elastic potential energy by means of the used spring. It is this spring that provides the plantar-flexing torque required at the ankle as reaction to the movement of the user. Due to the use of a locking system, the prosthesis can adapt its so-called zero torque rest point depending on the slope or stride length of the user. This provides adaptability and therefore greater comfort compared to prostheses with a fixed zero torque rest point. During the swing phase, the locking mechanism unlocks to free the ankle movement. Parallel springs external to the stance system are then activated to reset the foot to its initial position. From that moment, the device is ready for a new step.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis User, Amputation; Traumatic, Limb, Lower
Keywords
AMPfoot, Prosthetics, gait, electro-encephalography, dual-task walking
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Able-bodied individuals
Arm Type
Active Comparator
Arm Title
Transtibial amputee
Arm Type
Experimental
Arm Title
Transfemoral amputee
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AMPfoot 4.0
Intervention Description
The novel prosthetic device, i.e. AMPfoot 4.0, was tested during walking in amputees. A dual-task was conducted and non-invasive electro-encephalography was used to investigate neural dynamics.
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
The control group included healthy subjects. Comparisons were made between amputees and able-bodied individuals.
Primary Outcome Measure Information:
Title
Reaction time (in ms) of responses during go - no go cognitive task
Description
Time between visual stimulus and motor response (pushing button)
Time Frame
Through study completion, a period of 2 months
Title
Accuracy (in percentage) of correct responses during go - no go cognitive task
Description
Accuracy of motor responses to visual stimuli
Time Frame
Through study completion, a period of 2 months
Title
EEG extracted brain signals, i.e. motor-related cortical potentials
Description
Non-invasive electro-encephalography was used to determine electro-cortical potentials and brain sources of these potentials
Time Frame
Through study completion, a period of 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Unilateral transfemoral amputees
Unilateral transtibial amputees
Able-bodied individuals
Exclusion Criteria:
Children
Functional k-level lower than 4 (Amputee has the ability for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress or energy levels)
Facility Information:
Facility Name
Vrije Universiteit Brussel
City
Brussel
State/Province
Vlaams Brabant
ZIP/Postal Code
1050
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Strategic Research Program 17 (VUB Funding)
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