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

Primary Purpose

Gait Disorder, Sensorimotor

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
ANGELAA
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Gait Disorder, Sensorimotor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Balgrist

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

unilateral transfemoral amputees

Arm Description

Outcomes

Primary Outcome Measures

Change of gait pattern using an actuated transfemoral prosthesis compared to a passive prosthesis

Secondary Outcome Measures

Full Information

First Posted
October 29, 2014
Last Updated
April 27, 2015
Sponsor
Swiss Federal Institute of Technology
Collaborators
Balgrist University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02310841
Brief Title
Pilot Study for Patient-cooperative Control Strategies for Actuated Transfemoral Prostheses
Official Title
Pilotstudie zu Patientenkooperativen Regelungsstrategien für Aktuierte Oberschenkelexoprothesen
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
Balgrist University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait Disorder, Sensorimotor

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
unilateral transfemoral amputees
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ANGELAA
Intervention Description
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Riener, Prof. Dr
Organizational Affiliation
Sensory Motor Systems Lab, ETH Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Balgrist
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

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

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