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

Gait Disorder, Sensorimotor Clinical Trial

Official title:

Pilotstudie zu Patientenkooperativen Regelungsstrategien für Aktuierte Oberschenkelexoprothesen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310841
• Other study ID #: KEK-ZH-2013-0034
• Secondary ID: 2013-MD-0004
• Status: Completed
• Phase: N/A
• First received: October 29, 2014
• Last updated: April 27, 2015
• Start date: March 2013
• Est. completion date: February 2015

Study information

• Verified date: December 2014
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gait Disorder, Sensorimotor
• Gait Disorders, Neurologic

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Balgrist	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No