Evaluation of Usability and Human Factors in the Novus System

Sponsor

Bioness Neuromodulation (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02738242

Collaborator

Bioness Inc (Industry), Loewenstein Hospital (Other)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Drop Foot Muscle Weakness Motor Neuron Disease, Upper	Device: Novus system	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of Usability and Human Factors in the Novus System

Study Start Date :

May 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2017

Anticipated Study Completion Date :

Jan 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Questionnaire to evaluate system usability [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.
Patients' Questionnaire to evaluate system ease of use [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.

Secondary Outcome Measures

Patients Questionnaire to compare quality of life with and without the Novus system. [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.
Participation scale questionnaire (a sub-scale of Mayo-Portland Adaptability Inventory 4) for quality of life assessment compared to baseline [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.
Total score of modified Emory Functional Ambulation Profile (mEFAP) with the system compared to without the system. [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.
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. [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.
Walking velocity assessment using the 2 minute walk test (2MWT) with the system compared to without the system. [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.
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. [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.

Other Outcome Measures

Number of subjects with anticipated and unanticipated adverse events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.