Comprehensive Evaluation of the Passive Talaris Demonstrator
1 other identifier
interventional
8
1 country
1
Brief Summary
The passive Talaris Demonstrator (TD) is developed in continuation of previous prototypes. The main goal of the experiment is to evaluate the effectiveness of TD during daily activities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2021
CompletedFirst Submitted
Initial submission to the registry
October 4, 2021
CompletedFirst Posted
Study publicly available on registry
November 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2022
CompletedApril 29, 2022
April 1, 2022
1.2 years
October 4, 2021
April 28, 2022
Conditions
Outcome Measures
Primary Outcomes (7)
Performance
Heart rate during all tasks
Through study completion, a period of 4 months
Performance
Time needed to perform the L-test
Through study completion, a period of 4 months
Performance
Speed during 6 minutes walk test
Through study completion, a period of 4 months
Physiological
Electromyography: lower limb muscle activity during different movements (% of the MVC)
Through study completion, a period of 4 months
Physiological
Oxygen consumption during stair climbing, slope walking and during the 6 minutes walk test
Through study completion, a period of 4 months
Psychological
Visual analogue scale for comfort (score: 0= not comfortable, 100 = comfortable) and fatigue (score: 0= not fatiguing, 100 = fatiguing) during all tasks
Through study completion, a period of 4 months
Biomechanical
Joint angels and joint angular velocities of hip, knee and ankle joints
Through study completion, a period of 4 months
Study Arms (2)
Novel prosthesis
EXPERIMENTALA unilateral transtibial amputee will conduct experiments with the novel prosthesis followed by experiments with the current prosthesis.
Current prosthesis
ACTIVE COMPARATORA unilateral transtibial amputee will conduct experiments with the current prosthesis followed by experiments with the novel prosthesis.
Interventions
The amputee will walk with the passive Talaris Demonstrator, a novel prosthetic foot, designed and built by "Axiles Bionics".
Eligibility Criteria
You may qualify if:
- Unilateral transtibial (below knee) amputation
- Unilateral transfemoral (above knee) amputation
- Healthy subject
- Medicare Functional Classification Level: K2-4
You may not qualify if:
- Any neurological disease
- Upper limb or bilateral amputation
- Stump pain or bad fit of the socket
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vrije Universiteit Brussel
Brussels, 1050, Belgium
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin De Pauw
Vrije Universiteit Brussel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
October 4, 2021
First Posted
November 19, 2021
Study Start
January 21, 2021
Primary Completion
March 17, 2022
Study Completion
March 17, 2022
Last Updated
April 29, 2022
Record last verified: 2022-04