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Pilot study: Feasibility of prosthesis embedded sensors for real-world gait analysis

Conditions
Z89
Acquired absence of limb
Registration Number
DRKS00027052
Lead Sponsor
Ottobock SE & Co. KGaA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
20
Inclusion Criteria

Person is minimum 18 and maximum 60 years old; Person has unilateral transfemoral amputation or knee disarticulation with stable residual limb; Person is able to walk with everyday prosthesis; Person with a body weight of less than 100 kg; Person who is willing and able to independently provide informed consent; Person who is willing to comply with study procedures; Person who is currently fitted with a MPK (Genium, Genium X3 or C-Leg 5) for at least 6 months; Person who has an adequate, well-fitted socket; Person who is able to ramp and stair negotiation with or without walking aids; Person who is able to walk with a mechanical knee joint

Exclusion Criteria

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
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Showing the possibility of using prosthesis embedded sensors for gait analyses outside of a laboratory environment.
Secondary Outcome Measures
NameTimeMethod
ot applicable
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