Strategic Research Program 17 (VUB Funding)

NCT03498872 | Completed

• 1 other identifier: PROJECT-ID SRP 17
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthesis User; Amputation; Traumatic, Limb, Lower

Keywords

AMPfoot; Prosthetics; gait; electro-encephalography; dual-task walking

Outcome Measures

Primary Outcomes (3)

• Reaction time (in ms) of responses during go - no go cognitive task

  Time between visual stimulus and motor response (pushing button)

  Through study completion, a period of 2 months

• Accuracy (in percentage) of correct responses during go - no go cognitive task

  Accuracy of motor responses to visual stimuli

  Through study completion, a period of 2 months

• 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

  Through study completion, a period of 2 months

Study Arms (3)

Able-bodied individuals

ACTIVE COMPARATOR

Other: No intervention

Transtibial amputee

EXPERIMENTAL

Device: AMPfoot 4.0

Transfemoral amputee

EXPERIMENTAL

Device: AMPfoot 4.0

Interventions

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.

Transfemoral amputee; Transtibial amputee

No intervention OTHER

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

Able-bodied individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral transfemoral amputees
• Unilateral transtibial amputees
• Able-bodied individuals

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Vrije Universiteit Brussel

Brussels, Vlaams Brabant, 1050, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 17, 2018
• Study Start: October 1, 2016
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: April 17, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)