NCT02310841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

April 28, 2015

Status Verified

December 1, 2014

Enrollment Period

1.9 years

First QC Date

October 29, 2014

Last Update Submit

April 27, 2015

Conditions

Gait Disorder, Sensorimotor

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

unilateral transfemoral amputees

EXPERIMENTAL
Device: ANGELAA

Interventions

ANGELAADEVICE

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

unilateral transfemoral amputees

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Balgrist

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Riener, Prof. Dr

    Sensory Motor Systems Lab, ETH Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 29, 2014

First Posted

December 8, 2014

Study Start

March 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

April 28, 2015

Record last verified: 2014-12

Locations

CH(1)