Clinical trial NCT02738242: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Drop Foot
Muscle Weakness
Motor Neuron Disease, Upper
Keywords: Functional Electrical Stimulation
Upper motor neuron injury or disease
Drop foot
Thigh muscle weakness
Lead sponsor: Bioness Neuromodulation
Sponsor class: INDUSTRY
Collaborators: name: Bioness Inc
name: Loewenstein Hospital
First posted: 2016-04-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Questionnaire to evaluate system usability
timeFrame: End of week 4
measure: Patients' Questionnaire to evaluate system ease of use
timeFrame: End of week 4
Secondary outcomes:
measure: Patients Questionnaire to compare quality of life with and without the Novus system.
timeFrame: End of week 4 and end of week 12
measure: Participation scale questionnaire (a sub-scale of Mayo-Portland Adaptability Inventory 4) for quality of life assessment compared to baseline
timeFrame: Baseline and end of week 4 and 12
measure: Total score of modified Emory Functional Ambulation Profile (mEFAP) with the system compared to without the system.
timeFrame: Baseline and End of week 4
measure: 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.
timeFrame: Baseline and End of week 4, 8 and 12.
measure: Walking velocity assessment using the 2 minute walk test (2MWT) with the system compared to without the system.
timeFrame: Baseline and End of week 4
measure: 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.
timeFrame: Baseline and End of week 4, 8 and 12.
Other outcomes:
measure: Number of subjects with anticipated and unanticipated adverse events
timeFrame: Throughout the 12 weeks of the study
Locations:
city: Ra'anana
country: Israel
facility: Lowenstain hospital rehabilitation center
Study officials:
affiliation: Lowenstain Hospital Rehabilitation Center
name: Yaron Sacher, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.