Evaluation of Usability and Human Factors in the Novus System

NCT02738242 | Unknown

• 1 other identifier: Novus System Usability
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Drop Foot; Muscle Weakness; Motor Neuron Disease, Upper

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (6)

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

  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.

  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.

  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.

  Baseline and End of week 4

Other Outcomes (1)

• Number of subjects with anticipated and unanticipated adverse events

  Throughout the 12 weeks of the study

Study Arms (1)

Novus system users

EXPERIMENTAL

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

Interventions

Novus system DEVICE

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.

Novus system users

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioness Neuromodulation: lead
• Bioness Inc: collaborator
• Loewenstein Hospital: collaborator

Study Sites (1)

Lowenstain hospital rehabilitation center

Raanana, Israel

Location

Related Publications (5)

• 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.

  PMID: 23467567 BACKGROUND

• 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.

  PMID: 23097635 BACKGROUND

• 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.

  PMID: 24967447 BACKGROUND

• 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.

  PMID: 15569875 BACKGROUND

• 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.

  PMID: 18158427 BACKGROUND

MeSH Terms

Conditions

Peroneal Neuropathies; Muscle Weakness; Motor Neuron Disease; Disease

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurodegenerative Diseases

Study Officials

• Yaron Sacher, MD

  Lowenstain Hospital Rehabilitation Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronit Lipson, M.Sc.PT

CONTACT

09-7907153; ronit.lipson@bioness.co.il

Bella Kuchuk, PT, MHA

CONTACT

09- 7907130; bella.kuchuk@bioness.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: April 14, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 19, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)