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Evaluation of Usability and Human Factors in the Novus System

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ClinicalTrials.gov Identifier: NCT02738242
Recruitment Status : Unknown
Verified March 2016 by Bioness Neuromodulation.
Recruitment status was:  Not yet recruiting
First Posted : April 14, 2016
Last Update Posted : April 19, 2016
Sponsor:
Collaborators:
Bioness Inc
Loewenstein Hospital
Information provided by (Responsible Party):
Bioness Neuromodulation

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.

Condition or disease Intervention/treatment Phase
Drop Foot Muscle Weakness Motor Neuron Disease, Upper Device: Novus system Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Usability and Human Factors in the Novus System
Study Start Date : May 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Novus system users
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
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 Measures :
  1. Questionnaire to evaluate system usability [ Time Frame: End of week 4 ]
    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.

  2. Patients' Questionnaire to evaluate system ease of use [ Time Frame: End of week 4 ]
    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 :
  1. Patients Questionnaire to compare quality of life with and without the Novus system. [ Time Frame: End of week 4 and end of week 12 ]
    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.

  2. Participation scale questionnaire (a sub-scale of Mayo-Portland Adaptability Inventory 4) for quality of life assessment compared to baseline [ Time Frame: Baseline and end of week 4 and 12 ]
    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.

  3. Total score of modified Emory Functional Ambulation Profile (mEFAP) with the system compared to without the system. [ Time Frame: Baseline and End of week 4 ]
    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.

  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. [ Time Frame: Baseline and End of week 4, 8 and 12. ]
    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.

  5. Walking velocity assessment using the 2 minute walk test (2MWT) with the system compared to without the system. [ Time Frame: Baseline and End of week 4 ]
    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.

  6. 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. [ Time Frame: Baseline and End of week 4, 8 and 12. ]
    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.


Other Outcome Measures:
  1. Number of subjects with anticipated and unanticipated adverse events [ Time Frame: Throughout the 12 weeks of the study ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738242


Contacts
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Contact: Ronit Lipson, M.Sc.PT 09-7907153 ronit.lipson@bioness.co.il
Contact: Bella Kuchuk, PT, MHA 09- 7907130 bella.kuchuk@bioness.co.il

Locations
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Israel
Lowenstain hospital rehabilitation center Not yet recruiting
Ra`anana, Israel
Sponsors and Collaborators
Bioness Neuromodulation
Bioness Inc
Loewenstein Hospital
Investigators
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Principal Investigator: Yaron Sacher, MD Lowenstain Hospital Rehabilitation Center

Publications:
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Responsible Party: Bioness Neuromodulation
ClinicalTrials.gov Identifier: NCT02738242     History of Changes
Other Study ID Numbers: Novus System Usability
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bioness Neuromodulation:
Functional Electrical Stimulation
Upper motor neuron injury or disease
Drop foot
Thigh muscle weakness

Additional relevant MeSH terms:
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Muscle Weakness
Paresis
Motor Neuron Disease
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Neurodegenerative Diseases
Neuromuscular Diseases