Evaluation of Usability and Human Factors in the Novus System

Bioness

Status: Unknown

Conditions: Motor Neuron Disease, Upper; Muscle Weakness; Drop Foot

Treatments: Device: Novus system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02738242

Novus System Usability

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

16 participants in 1 patient group

Novus system users

Experimental group

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.

Treatment:

Device: Novus system