Evaluation of Usability and Human Factors in the Novus System

Muscle Weakness Clinical Trial

Official title:

Evaluation of Usability and Human Factors in the Novus System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02738242
• Other study ID #: Novus System Usability
• Status: Not yet recruiting
• Phase: N/A
• First received: March 3, 2016
• Last updated: April 17, 2016
• Start date: May 2016
• Est. completion date: January 2017

Study information

• Verified date: March 2016
• Source: Bioness Neuromodulation
• Contact: Ronit Lipson, M.Sc.PT
• Phone: 09-7907153
• Email: ronit.lipson[@]bioness.co.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Israel	Lowenstain hospital rehabilitation center	Ra`anana

Sponsors (3)

Lead Sponsor	Collaborator
Bioness Neuromodulation	Bioness Inc, Loewenstein Hospital

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. Epub 2004 Nov 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of subjects with anticipated and unanticipated adverse events	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	Yes
Primary	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.	End of week 4	No
Primary	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.	End of week 4	No
Secondary	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.	End of week 4 and end of week 12	No
Secondary	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.	Baseline and end of week 4 and 12	No
Secondary	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.	Baseline and End of week 4	No
Secondary	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.	Baseline and End of week 4, 8 and 12.	No
Secondary	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.	Baseline and End of week 4	No
Secondary	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.	Baseline and End of week 4, 8 and 12.	No