Drop FootNCT02738242
Evaluation of Usability and Human Factors in the Novus System
A study testing Novus system in people with Drop Foot and Muscle Weakness, run by Bioness Neuromodulation at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Drop Foot, Muscle Weakness, Motor Neuron Disease, Upper
- What is being tested?
- Novus system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIsrael
- Study dates
- May 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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).
Who cannot join
- 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)
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Drop Foot, Muscle Weakness, Motor Neuron Disease, Upper
- Being tested
- Novus system
- Keywords
- Functional Electrical Stimulation, Upper motor neuron injury or disease, Drop foot, Thigh muscle weakness
- Medical subject headings
- Peroneal Neuropathies, Muscle Weakness, Motor Neuron Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novus systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Novus system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: End of week 4
Secondary outcomes (6)
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.
Measured: 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
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Baseline and End of week 4
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.
Measured: Baseline and End of week 4, 8 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Drop FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioness Neuromodulation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioness Inc, Loewenstein Hospital
- Responsible party
- Sponsor
- Investigators
- Yaron Sacher, MD, Principal investigator, Lowenstain Hospital Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738242
- Sponsor's protocol ID
- Novus System Usability
- Status last verified
- Mar 2016
- First submitted
- 3 Mar 2016
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23467567Springer 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.
PubMed 23097635Springer 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.
PubMed 24967447Yan 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.
PubMed 15569875Hausdorff 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.
PubMed 18158427
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Usability and Human Factors in the Novus System
- ClinicalTrials.gov ID
- NCT02738242
- Acronym / sponsor ID
- Novus System Usability
- Conditions
- Drop Foot, Muscle Weakness, Motor Neuron Disease, Upper
- Keywords
- Functional Electrical Stimulation, Upper motor neuron injury or disease, Drop foot, Thigh muscle weakness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Bioness NeuromodulationIndustry (pharma, biotech, devices)
- Collaborators
- Bioness Inc, Loewenstein Hospital
- Study start
- May 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novus system users | Experimental | Device: Novus systemSixteen (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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novus systemThe 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. | Device | Novus system users |
Primary outcome
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.
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.
6 secondary outcomes
Patients Questionnaire to compare quality of life with and without the Novus system.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and End of week 4
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Background: PubMed 23467567Springer 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.
- Background: PubMed 23097635Springer 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.
- Background: PubMed 24967447Springer 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.
- Background: PubMed 15569875Yan 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.
- Background: PubMed 18158427Hausdorff 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.
- Individual participant dataSharing planned: No
Related trials for Drop Foot
Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
Not yet recruitingObservational study
Muscle MRI Fat Fraction Before Surgery to Predict Strength Recovery After Foot-Drop Surgery in Charcot-Marie-Tooth Disease
Foot Drop, Charcot-Marie-Tooth Disease Type 1A
Recruiting
Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop
Falls, Foot Drop
Recruiting
ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation
Cerebrovascular Stroke, Foot Drop
Recruiting
Characterization and Clinical Trial of a Variable Friction Shoe
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaron Sacher, MD principal investigator
Lowenstain Hospital Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novus system in people with Drop Foot and Muscle Weakness, run by Bioness Neuromodulation at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronit Lipson, M.Sc.PT (09-7907153, ronit.lipson@bioness.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire to evaluate system usability (time frame: End of week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02738242, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.