Strategic Research Program 17 (VUB Funding)

• ClinicalTrials.gov Identifier: NCT03498872
• Recruitment Status: Completed
• First Posted: April 17, 2018
• Last Update Posted: April 17, 2018
• Sponsor: Vrije Universiteit Brussel
• Information provided by (Responsible Party): Romain Meeusen, Vrije Universiteit Brussel

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.

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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)

Contacts and Locations

Locations

Belgium

Vrije Universiteit Brussel

Brussel, Vlaams Brabant, Belgium, 1050

Sponsors and Collaborators

Vrije Universiteit Brussel

More 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
• Last Update Posted: April 17, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Amputation, Traumatic; Wounds and Injuries