A Comprehensive Evaluation of a the Talaris Demonstrator
TD
1 other identifier
interventional
10
0 countries
N/A
Brief Summary
The Talaris Demonstrator is developed in continuation of previous prototypes called the AMPfoot 2.0, 3.0 and 4.0. 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 Feb 2021
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
First Submitted
Initial submission to the registry
October 21, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedDecember 4, 2020
December 1, 2020
5 months
October 21, 2020
December 2, 2020
Conditions
Outcome Measures
Primary Outcomes (9)
Biomechanical: step length
Step Length in cm
1 year
Biomechanical: cadence
Cadence steps/min
1 year
Biomechanical: step width
Step width in cm
1 year
Biomechanical: swing phases
in % of gait cycle
1 year
Biomechanical: stance phases
in % of gait cycle
1 year
Physiological: oxygen consumption
in ml/min/kg
1 year
Psychological: Visual Analogue Scale
For Fatigue and Comfort on a scale from 0 to 10
1 year
Performance: walking speed
In meter per second
1 year
Performance: duration
secondfs
1 year
Study Arms (4)
Biomechanical
OTHERAll experimental tasks will be evaluated on biomechanical outcome measures
Psychological
OTHERAll experimental tasks will be evaluated on psychological outcome measures
Physiological
OTHERAll experimental tasks will be evaluated on biomechanical outcome measures
Performance
OTHERAll experimental tasks will be evaluated on biomechanical outcome measures
Interventions
The Talaris Demonstrator will be evaluated during daily activities and compared to the current prosthesis
Eligibility Criteria
You may qualify if:
- Age: 25 - 75 years
- Gender: men and women
- Level of amputation: unilateral transfemoral
- Vascular, traumatic, congenital or other cause of amputation
- Completed the rehabilitation program, meaning that participants possess their final prosthesis
- Medicare Functional Classification Level: K2-4
- Participants wear their prosthesis for at least 8 hours/day
You may not qualify if:
- Any neurological disease
- No upper limb or bilateral amputation
- Stump pain or bad fit of the socket
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctorandus
Study Record Dates
First Submitted
October 21, 2020
First Posted
October 22, 2020
Study Start
February 1, 2021
Primary Completion
June 30, 2021
Study Completion
December 31, 2021
Last Updated
December 4, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share