Evaluation of Usability and Human Factors in the Novus System

April 17, 2016 updated by: Bioness Neuromodulation
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study will be carried out in two phases. Phase one (4 weeks) will focus on evaluating the usability of the Novus system. Phase two (8 weeks) will enable continued clinical follow up. The study will include sixteen (16) subjects suffering from foot drop and thigh muscles weakness due to upper motor neuron injury or disease; eight (8) subjects will be new users with no Functional Electrical Stimulation (FES) experience and the other eight (8) will be experienced Ness L300/Ness L300 Plus users. Phase two of the study will include only the new users.

The primary objective of the study is to evaluate the usability of the Novus system among these patients and 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. System usability will be evaluated by adapted 5 point Likert scale usability questionnaire and patient's feedback questionnaire. Quality of life (QoL) will be measured through Participation scale questionnaire and functional ambulation assessments; modified Emory Functional Ambulation Profile (mEFAP) that will be performed with and without the system and 2 minute walk test (2MWT) with and without the system.

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Ra'anana, Israel
        • Lowenstain hospital rehabilitation center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Upper motor neuron injury or disease.
  • Foot drop - toe drag during walking.
  • Lower limb spasticity- 0-4 according to the modified Ashworth scale.
  • Responsible mental state, able to follow multiple step directions.
  • Aged between 18 and 80 years old.
  • At least six months post diagnosis
  • Available for participating in the study.
  • Able to understand and sign the informed consent form.
  • Able to walk independently or with an assisting device (e.g. cane, walker etc.) / spot guarding for at least 10 meters.
  • Sufficient response to electrical stimulation (visible muscle contractions in a seated or prone position of each designated muscle separately).

Exclusion Criteria:

  • Subjects with a demand-type cardiac pacemaker, defibrillator or any electrical or metallic implant.
  • Cancerous lesion of lower limb, present or suspected.
  • Medical condition that prevents participation or would likely lead to inability to comply with the protocol [e.g.: congestive heart failure, patient receiving chemotherapy, uncontrolled epilepsy, etc.].
  • Skin lesion at the site of the stimulation electrodes.

  • Change in bone-joint structures of the lower limb, such as:

    • Contractures (ROM of dorsiflexion < 0)
    • Deformations; fracture or dislocation, which would be adversely affected by motion from the stimulation.
  • Pregnancy.
  • Diagnosis of major depression or psychotic disorder.
  • Participation in another investigation that may directly or indirectly affect the study results.
  • Unable to tolerate electrical stimulation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Novus system users
Sixteen (16) subjects suffering from foot drop and thigh muscles weakness due to upper motor neuron injury or disease will be recruit for this study and will receive the Novus system for daily use.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire to evaluate system usability
Time Frame: End of week 4
System usability will be evaluated by a usability questionnaire that was constructed according to the system's requirements. Subjects will be asked to complete a series of actions regarding the overall operation of the system. Each action will be rated in a 5 point likert scale, according to the performance. An average score will be calculated for each question.
End of week 4
Patients' Questionnaire to evaluate system ease of use
Time Frame: End of week 4
System usability will be also evaluated by Patients' Questionnaire (section A). Subjects will be asked to provide their feedback regarding the ease of use (rated in a 5 point likert scale). An average score will be calculated for each question.
End of week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients Questionnaire to compare quality of life with and without the Novus system.
Time Frame: End of week 4 and end of week 12
Quality of Life will be evaluated by patients' questionnaire (section B). Subjects will be asked to give their feedback concerning their quality of life with and without the system after 4 weeks of use. Each question will be rated according to 5 likert scale. An average score will be calculated for each question. New users will be asked to fill in the questionnaire again, after 12 weeks of use in order to assess adaptability to the system.
End of week 4 and end of week 12
Participation scale questionnaire (a sub-scale of Mayo-Portland Adaptability Inventory 4) for quality of life assessment compared to baseline
Time Frame: Baseline and end of week 4 and 12
Quality of life (QoL) will be also measured through Participation scale questionnaire (a sub-scale of Mayo-Portland Adaptability Inventory 4) and will be compared to baseline results. New users will be asked to fill in the questionnaire again, after additional 8 weeks of use in order to assess changes after adaptability to the system.
Baseline and end of week 4 and 12
Total score of modified Emory Functional Ambulation Profile (mEFAP) with the system compared to without the system.
Time Frame: Baseline and End of week 4
Functional ambulation assessments will be measured through modified Emory Functional Ambulation Profile (mEFAP). The test will be performed with the system compared to without the system in order to assess orthotic effect.
Baseline and End of week 4
Total score of modified Emory Functional Ambulation Profile (mEFAP) without the system at baseline compared to without the system after daily use with the system.
Time Frame: Baseline and End of week 4, 8 and 12.
The test will be performed at baseline compared to end of week 4 after daily use with the system in order to assess therapeutic effect. New users will be also evaluated at week 8 and 12.
Baseline and End of week 4, 8 and 12.
Walking velocity assessment using the 2 minute walk test (2MWT) with the system compared to without the system.
Time Frame: Baseline and End of week 4
2 minute walk test (2MWT) will be performed with the system compared to without the system at baseline and end of week 4 in order to assess orthotic effect.
Baseline and End of week 4
walking velocity assessment using the 2 minute walk test (2MWT) without the system at baseline compared to without the system after daily use with the system.
Time Frame: Baseline and End of week 4, 8 and 12.
The test will be performed at baseline and compared to end of week 4 after daily use with the system in order to assess therapeutic effect. New users will be also evaluated at week 8 and 12.
Baseline and End of week 4, 8 and 12.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with anticipated and unanticipated adverse events
Time Frame: Throughout the 12 weeks of the study
The occurence of anticipated and unanticipated events will be documented at each scheduled evaluation. In addition, subjects will be instructed to report adverse events 24 hours per day during the study period.
Throughout the 12 weeks of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioness Neuromodulation

Collaborators

Loewenstein Hospital
Bioness Inc

Investigators

  • Principal Investigator: Yaron Sacher, MD, Lowenstain hospital rehabilitation center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ANTICIPATED)

January 1, 2017

Study Completion (ANTICIPATED)

January 1, 2017

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

April 10, 2016

First Posted (ESTIMATE)

April 14, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 17, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Novus System Usability

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Muscle Weakness

Clinical Trials on Novus system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe