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Evaluation of Usability and Human Factors in the Novus System

Primary Purpose

Drop Foot, Muscle Weakness, Motor Neuron Disease, Upper

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Novus system

About this trial

This is an interventional treatment trial for Drop Foot focused on measuring Functional Electrical Stimulation, Upper motor neuron injury or disease, Drop foot, Thigh muscle weakness

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Lowenstain hospital rehabilitation center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Novus system users

Arm Description

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.

Outcomes

Primary Outcome Measures

Questionnaire to evaluate system usability

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

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.

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

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02738242

First Posted

March 3, 2016

Last Updated

April 17, 2016

Sponsor

Bioness Neuromodulation

Collaborators

Bioness Inc, Loewenstein Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02738242

Brief Title

Evaluation of Usability and Human Factors in the Novus System

Official Title

Evaluation of Usability and Human Factors in the Novus System

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioness Neuromodulation

Collaborators

Bioness Inc, Loewenstein Hospital

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drop Foot, Muscle Weakness, Motor Neuron Disease, Upper

Keywords

Functional Electrical Stimulation, Upper motor neuron injury or disease, Drop foot, Thigh muscle weakness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Novus system users

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Novus system

Intervention Description

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.

Primary Outcome Measure Information:

Title

Questionnaire to evaluate system usability

Description

Time Frame

End of week 4

Title

Patients' Questionnaire to evaluate system ease of use

Description

Time Frame

End of week 4

Secondary Outcome Measure Information:

Title

Patients Questionnaire to compare quality of life with and without the Novus system.

Description

Time Frame

End of week 4 and end of week 12

Title

Participation scale questionnaire (a sub-scale of Mayo-Portland Adaptability Inventory 4) for quality of life assessment compared to baseline

Description

Time Frame

Baseline and end of week 4 and 12

Title

Total score of modified Emory Functional Ambulation Profile (mEFAP) with the system compared to without the system.

Description

Time Frame

Baseline and End of week 4

Title

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.

Description

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.

Time Frame

Baseline and End of week 4, 8 and 12.

Title

Walking velocity assessment using the 2 minute walk test (2MWT) with the system compared to without the system.

Description

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.

Time Frame

Baseline and End of week 4

Title

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.

Description

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.

Time Frame

Baseline and End of week 4, 8 and 12.

Other Pre-specified Outcome Measures:

Title

Number of subjects with anticipated and unanticipated adverse events

Description

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.

Time Frame

Throughout the 12 weeks of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ronit Lipson, M.Sc.PT

Phone

09-7907153

ronit.lipson@bioness.co.il

First Name & Middle Initial & Last Name or Official Title & Degree

Bella Kuchuk, PT, MHA

Phone

09- 7907130

bella.kuchuk@bioness.co.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yaron Sacher, MD

Organizational Affiliation

Lowenstain Hospital Rehabilitation Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lowenstain hospital rehabilitation center

City

Ra'anana

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23467567

Citation

Springer S, Laufer Y, Becher M, Vatine JJ. Dual-channel functional electrical stimulation improvements in speed-based gait classifications. Clin Interv Aging. 2013;8:271-7. doi: 10.2147/CIA.S41141. Epub 2013 Feb 28.

Results Reference

background

PubMed Identifier

23097635

Citation

Springer S, Vatine JJ, Lipson R, Wolf A, Laufer Y. Effects of dual-channel functional electrical stimulation on gait performance in patients with hemiparesis. ScientificWorldJournal. 2012;2012:530906. doi: 10.1100/2012/530906. Epub 2012 Oct 11.

Results Reference

background

PubMed Identifier

24967447

Citation

Springer S, Khamis S, Laufer Y. Improved ankle and knee control with a dual-channel functional electrical stimulation system in chronic hemiplegia. A case report. Eur J Phys Rehabil Med. 2014 Apr;50(2):189-95. Epub 2012 Jul 23.

Results Reference

background

PubMed Identifier

15569875

Citation

Yan T, Hui-Chan CW, Li LS. Functional electrical stimulation improves motor recovery of the lower extremity and walking ability of subjects with first acute stroke: a randomized placebo-controlled trial. Stroke. 2005 Jan;36(1):80-5. doi: 10.1161/01.STR.0000149623.24906.63. Epub 2004 Nov 29.

Results Reference

background

PubMed Identifier

18158427

Citation

Hausdorff JM, Ring H. Effects of a new radio frequency-controlled neuroprosthesis on gait symmetry and rhythmicity in patients with chronic hemiparesis. Am J Phys Med Rehabil. 2008 Jan;87(1):4-13. doi: 10.1097/PHM.0b013e31815e6680.

Results Reference

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Evaluation of Usability and Human Factors in the Novus System

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