MedTrace Logo

Evaluation of Usability and Human Factors in the Novus System

NCT02738242 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-04-19

No results posted yet for this study

Summary

The Novus system intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. The primary objective of the study is to evaluate the usability of the Novus system among these patients and to gain subjects' feedback regarding the device when used on a daily basis.The secondary objective is to obtain information about the performance of the system as a gait assistive device and to evaluate the subject's Quality of Life while using the system.

Conditions

  • Drop Foot
  • Muscle Weakness
  • Motor Neuron Disease, Upper

Interventions

DEVICE

Novus system

The Novus system is a FES based neuroprosthesis, which intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease.

Sponsors & Collaborators

  • Bioness Inc

    collaborator INDUSTRY

  • Loewenstein Hospital

    collaborator OTHER

  • Bioness Neuromodulation

    lead INDUSTRY

Principal Investigators

  • Yaron Sacher, MD · Lowenstain Hospital Rehabilitation Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02738242 on ClinicalTrials.gov