Pilot Study for Patient-cooperative Control Strategies for Actuated Transfemoral Prostheses
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|ClinicalTrials.gov Identifier: NCT02310841|
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : April 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gait Disorder, Sensorimotor||Device: ANGELAA||Not Applicable|
Setting of the study: Conventional prostheses for transfemoral amputees are mostly simple mechanic joints, or have micro-processor-controlled damping. The prototype tested in this study is equipped with a motor that can actively move the knee joint. Therefore, movements like, for example, alternating stair climbing, are possible that cannot be realized with pure mechanical and actively damped prostheses. During level-ground walking, it is hypothesized that less compensatory movements are needed. We have developed an actuated prototypical prosthesis and new control strategies which should facilitate both level-ground walking and stair climbing. Parts of the control strategies have been tested in able-bodied subjects . This control strategy has been extended such that only biological stiffness modulation can be rendered .
Hypothesis: Subjects can use our transfemoral prosthesis to walk on level-ground, to climb several steps and to overcome small obstacles without prior training. The user-cooperative control is intuitive and easily learnable.
Objective of the study: This pilot study is meant to investigate the general feasibility of novel control strategies for actuated transfemoral prostheses. Parameters of a standard gait analysis, like ground reaction forces and kinematics (using a motion capture system), will be recorded. From this data, gait symmetry, step length, walking speed, and other measures can be calculated. The subjective impression of the user will be evaluated with a questionnaire.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Pilotstudie zu Patientenkooperativen Regelungsstrategien für Aktuierte Oberschenkelexoprothesen|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
|Experimental: unilateral transfemoral amputees||
Different control strategies with transfemoral prosthesis prototype ANGELAA, developed at the Sensory-Motor Systems Lab, ETH Zurich, not commercially available, only 1 device exists
- Change of gait pattern using an actuated transfemoral prosthesis compared to a passive prosthesis [ Time Frame: Subjects will come to the gait lab for two days. The experiment itself lasts about 1.5 hours per day. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310841
|University Hospital Balgrist|
|Zurich, Switzerland, 8008|
|Principal Investigator:||Robert Riener, Prof. Dr||Sensory Motor Systems Lab, ETH Zurich|