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OpenTrials
Completed

NCT Number: NCT03498872

Strategic Research Program 17 (VUB Funding)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vrije Universiteit Brussel

Brussels, Vlaams Brabant, 1050, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AMPfoot 4.0

Device

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.

No intervention

Other

The control group included healthy subjects. Comparisons were made between amputees and able-bodied individuals.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study title

Exercise and the Brain in Health & Disease: The Added Value of Human-Centered Robotics

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 17, 2018
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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