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

NCT ID: NCT02310841

Last Updated: 2015-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-02-28

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.

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.

Conditions

Gait Disorder, Sensorimotor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

unilateral transfemoral amputees

Group Type: EXPERIMENTAL

ANGELAA

Intervention Type: DEVICE

Different control strategies with transfemoral prosthesis prototype ANGELAA, developed at the Sensory-Motor Systems Lab, ETH Zurich, not commercially available, only 1 device exists

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Balgrist University Hospital

OTHER

Sponsor Role: collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Verena Klamroth

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Riener, Prof. Dr

Role: PRINCIPAL_INVESTIGATOR

Sensory Motor Systems Lab, ETH Zurich

Locations

University Hospital Balgrist

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2013-MD-0004

Identifier Type: OTHER

Identifier Source: secondary_id

KEK-ZH-2013-0034

Identifier Type: -

Identifier Source: org_study_id