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Pilot Study for Patient-cooperative Control Strategies for Actuated Transfemoral Prostheses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02310841
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : April 28, 2015
Balgrist University Hospital
Information provided by (Responsible Party):
Verena Klamroth, Swiss Federal Institute of Technology

Brief Summary:
This pilot study investigates the feasibility of novel control strategies for actuated transfemoral prostheses. Several parameters from gait analysis (including motion-capture and ground reaction force measurements) are analyzed. The subjective perception of prosthetic functionality is captured with a questionnaire.

Condition or disease Intervention/treatment Phase
Gait Disorder, Sensorimotor Device: ANGELAA Not Applicable

Detailed Description:

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 [1]. This control strategy has been extended such that only biological stiffness modulation can be rendered [2].

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
Experimental: unilateral transfemoral amputees Device: ANGELAA
Different control strategies with transfemoral prosthesis prototype ANGELAA, developed at the Sensory-Motor Systems Lab, ETH Zurich, not commercially available, only 1 device exists

Primary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 18 years old
  • Written consent of participant
  • For amputees: regular use of a transfemoral prosthesis
  • For amputees: transfemoral amputation

Exclusion Criteria:

  • Bodymass > 100 kg
  • For amputees: mobility class 1
  • For amputees: no stable residual leg volume
  • For amputees: constrictive contractures

Information from the National Library of Medicine

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 identifier (NCT number): NCT02310841

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University Hospital Balgrist
Zurich, Switzerland, 8008
Sponsors and Collaborators
Swiss Federal Institute of Technology
Balgrist University Hospital
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Principal Investigator: Robert Riener, Prof. Dr Sensory Motor Systems Lab, ETH Zurich
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Responsible Party: Verena Klamroth, MD, Swiss Federal Institute of Technology Identifier: NCT02310841    
Other Study ID Numbers: KEK-ZH-2013-0034
2013-MD-0004 ( Other Identifier: Swissmedic )
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: December 2014
Additional relevant MeSH terms:
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Gait Disorders, Neurologic
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms