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

Sponsor

Swiss Federal Institute of Technology (Other)

Overall Status

Completed

CT.gov ID

NCT02310841

Collaborator

Balgrist University Hospital (Other)

Enrollment

Location

Arm

23.1

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

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 :

Mar 1, 2013

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change of gait pattern using an actuated transfemoral prosthesis compared to a passive prosthesis [Subjects will come to the gait lab for two days. The experiment itself lasts about 1.5 hours per day.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Balgrist	Zurich		Switzerland	8008

Sponsors and Collaborators

Swiss Federal Institute of Technology
Balgrist University Hospital

Investigators

Principal Investigator: Robert Riener, Prof. Dr, Sensory Motor Systems Lab, ETH Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Verena Klamroth, MD, Swiss Federal Institute of Technology

ClinicalTrials.gov Identifier:

NCT02310841

Other Study ID Numbers:

KEK-ZH-2013-0034
2013-MD-0004

First Posted:

Dec 8, 2014

Last Update Posted:

Apr 28, 2015

Last Verified:

Dec 1, 2014

Additional relevant MeSH terms:

Gait Disorders, Neurologic

Study Results

No Results Posted as of Apr 28, 2015