DESIGN OF REAL-TIME NEUROMUSCULOSKELETAL MODELS FOR INTUITIVE AND ROBUST POWERED ANKLE PROSTHESIS CONTRO

• Conditions: amputations; limb loss; lower limb amputation; 10005942

• Registration Number: NL-OMON56131
• Lead Sponsor: niversity of Twente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:

Person is minimum 18 and maximum 60 years old.
Person has unilateral transtibial amputation
Person is able to walk with everyday prosthesis
Person with a body weight of less than 120 kg and BMI in the range from
18.5 to 29.9 kg/m^2 ( normal to overweight)
Person who is willing and able to independently provide informed consent
Person who is willing to comply with study procedures
Person who finished rehabilitation trajectory and using own prosthesis
at home for > 3 months.
Person who has an adequate, well-fitted socket
Functional level from K3 to K4 ( even if balance issues occurs more for
K2, for the current protocol that includes walking sessions on the treadmill it
is better to exclude them to be able to complete the trial):
Level 3: The patient has the ability or potential for ambulation with variable
cadence. Typical of the community ambulatory who has the ability to traverse
most environmental barriers and may have vocational, therapeutic, or exercise
activity that demands prosthetic utilization beyond simple locomotion.
Level 4: The patient has the ability or potential for prosthetic ambulation that
exceeds basic ambulation skills, exhibiting high impact, stress, or energy
levels. Typical of the prosthetic demands of the child, active adult, or
athlete.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
* Pregnant women
* Person with conditions that would prevent participation and pose increased
risk (e.g. unstable cardiovascular conditions that preclude physical activity
such as walking)
* Person with weakened bones (e.g. osteoporosis)
* Person with a history of chronic skin breakdown of the residual limb
* Person who falls at least once a week for reasons that are not related to
prosthetic use (e.g. problems with vestibular system)
* Person who has life-threatening medical condition (e.g. terminal cancer,
severe heart disease)
* Person who is using under arm axillary crutches or walker
* Person in an emergency, life threatening situation
* Person who underwent osseointegration operation
* Person who is allergic to band aids or glue

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified