amputations limb loss lower limb amputation
Conditions
Interventions
None listed
Sponsors
University of Twente
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are comparisons between measurements performed with different controllers of the EMPOWER to evaluate their effect: • Gait kinematics (a), obtained from patients Comparison with the default controller Left-to-right asymmetry • Peak of the joint torque and timing of joint torque (a) Comparison with the default controller Analysis between the sound side and the prosthetic side • Ankle and knee power (a) Comparison with the default controller Analysis between the sound side and the prosthetic side • Differences between control input (e)(b)(a) • Data from all sensors are used to evaluate the step length, step height, speed estimation, loading of the prosthesis, foot placement, healthy and prosthetic joint torques, and evaluate correct switching between different speeds • COM, COP and GRF signals (a) to evaluate the balance strategies (recovery) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are: • Joint compression load at the ankle and knee (a) Comparison with the default controller Analysis between the sound side and the prosthetic side • Joint torque and timing of joint torque (a) Comparison with the default controller Analysis between the sound side and the prosthetic side • Output from the prosthesis • Work at the ankle joint on the prosthetic side • Muscle activity (b) to evaluate changes in the use of different controllers | — |
Countries
Netherlands
Outcome results
None listed