Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Strategic Research Program 17 (VUB Funding)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498872
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Romain Meeusen, Vrije Universiteit Brussel

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.


Condition or disease Intervention/treatment Phase
Prosthesis User Amputation; Traumatic, Limb, Lower Device: AMPfoot 4.0 Other: No intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exercise and the Brain in Health & Disease: The Added Value of Human-Centered Robotics
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : December 15, 2016

Arm Intervention/treatment
Active Comparator: Able-bodied individuals Other: No intervention
The control group included healthy subjects. Comparisons were made between amputees and able-bodied individuals.

Experimental: Transtibial amputee Device: AMPfoot 4.0
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.

Experimental: Transfemoral amputee Device: AMPfoot 4.0
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.




Primary Outcome Measures :
  1. Reaction time (in ms) of responses during go - no go cognitive task [ Time Frame: Through study completion, a period of 2 months ]
    Time between visual stimulus and motor response (pushing button)

  2. Accuracy (in percentage) of correct responses during go - no go cognitive task [ Time Frame: Through study completion, a period of 2 months ]
    Accuracy of motor responses to visual stimuli

  3. EEG extracted brain signals, i.e. motor-related cortical potentials [ Time Frame: Through study completion, a period of 2 months ]
    Non-invasive electro-encephalography was used to determine electro-cortical potentials and brain sources of these potentials



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498872


Locations
Layout table for location information
Belgium
Vrije Universiteit Brussel
Brussel, Vlaams Brabant, Belgium, 1050
Sponsors and Collaborators
Vrije Universiteit Brussel

Layout table for additonal information
Responsible Party: Romain Meeusen, Prof. Dr., Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT03498872    
Other Study ID Numbers: PROJECT-ID SRP 17
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Romain Meeusen, Vrije Universiteit Brussel:
AMPfoot
Prosthetics
gait
electro-encephalography
dual-task walking
Additional relevant MeSH terms:
Layout table for MeSH terms
Amputation, Traumatic
Wounds and Injuries