AzTrials
AzTrials

StrokeNCT01952613

Effect of FES Interventions on Gait Dynamics in Stroke Population

A study testing FES in people with Stroke and Foot Drop, run by Kessler Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Our proposal quantitatively analyzes gait dynamics of hemiplegic individuals in response to the Function Electrical Stimulation (FES) intervention and identifies the responders to the intervention. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stroke, Foot Drop
What is being tested?
FES
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Apr 2013to Apr 2016
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must have sustained a stroke at least 6 months prior to study enrollment
  • Must have hemiplegia with foot drop
  • Must have positive response to peroneal nerve stimulation resulting in adequate dorsiflexion of the ankle
  • No current usage of Functional Electrical Stimulations for the treatment of foot drop
  • No history of injury or pathology to the unaffected limb
  • Must be able to walk independently or with close supervision, for 25 feet without WalkAide or any assistive device

Who cannot join

  • Orthopedic pathologies or history that will interfere with ambulation or limit the range of motion of the lower limbs
  • Neuromuscular pathologies or history that will interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
  • Neurological pathologies (e.g., multiple sclerosis)
  • Serious lung or heart conditions that could severely limit their ability to walk
  • Current involvement in any other study that can affect the results of this study
  • Inability or unwillingness to comply with study procedures, follow-up requirements and follow instructions

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Kessler Foundation

    West Orange, New Jersey, 07052

Other trials in United States

About this study

Official title: Identification of Responders to the FES Interventions in Stroke Population

Our proposal quantitatively analyzes gait dynamics of hemiplegic individuals in response to the Function Electrical Stimulation (FES) intervention and identifies the responders to the intervention. This study will improve our knowledge of FES intervention and help clinicians strategize the FES interventions more effectively based on the responders' gait characteristics, thus supporting the NINDS' fundamental goal of translating basic and clinical discoveries into better ways to prevent and treat neurological disorders.

Read the detailed description

Hemiplegia with associated foot drop occurs in 50% of the stroke survivors and frequently impairs an individual's ability to walk. Functional Electrical Stimulation (FES) based neuroprosthetic devices have been developed to correct foot drop. The efficacy of these devices were initially examined by Liberson el al. who demonstrated that electrical stimulations could assist in restoring functional movements in paralyzed limbs. In addition to assistance with foot drop, these devices have showed significant improvements in biomechanical variables such as walking speed, distance, stride length and physiological cost for individuals with stroke. In order to comprehensively understand the effect of electrical stimulations on gait recovery, it is critical to analyze the dynamic aspects of gait and measure gait variability during the functional electrical stimulation intervention. In the proposed investigation, we will determine the 'gait symmetry' of FES assisted walking using bilateral cyclograms of the ankle and knee over a period of 6 months. This novel approach will account for the dynamics and complexity of balance by measuring the deviations of joints from a line of symmetry at every instance of gait cycle and will provide better measure of gait symmetry. Utilization of this outcome measure will allow us to understand the role of electrical stimulation at ankle and how this effect gets translated to the knee and hip joints during walking. The changes in the surface electromyograms (EMGs) of selective muscle groups will demonstrate how FES can contribute to muscle re-training after stroke. We will use advanced signal processing algorithms to remove FES artifact from the EMG signal in order to comprehensively analyze the carry-over effect of the FES intervention. Finally, we will employ Principal Component Analysis (PCA) - an advanced data mining technique to track and quantify the overall gait recovery process of individuals with stroke using pattern classification algorithms. The gait symmetry measure and the EMGs will be statistically classified to see their clear separation at baseline and 6 month intervals. This classification will allow us to identify the individuals who were most responsive to the intervention. This information is critical and will allow researchers and clinicians to re-strategize the rehabilitation process. Such scientific evaluation will provide the base for further development and implementation of FES devices or technologies, thus supporting the NINDS' fundamental goal of translating basic and clinical discoveries into better ways to treat neurological disorders.

Conditions
Stroke, Foot Drop
Being tested
FES
Keywords
Foot drop, Functional Electrical Stimulation
Medical subject headings
Stroke, Peroneal Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FESDevice

    In phase 1, five subjects (randomly chosen) will be provided the FES device and instructed to use it for ambulation for the 6 months. At the baseline visit, gait data will be collected from this group. On the 6 month follow up visit, same data collection procedure will be performed and the devices will be collected back from the subjects. After performing quality check on these devices, phase 2 of the data collection will start by providing the devices to the other five subjects and their baseline data will be collected.

Study groups in NCT01952613
Study groupRoleWhat they receive
Stroke - FESExperimentalStroke population currently prescribed a FES orthotic device (< week)
Receives: Device: FES

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gait Symmetry

    The kinematic data (3D Marker coordinates) obtained from ankle, knee and hip will be used for creating the bilateral cyclograms. The anterior-posterior angles will be plotted on the x-axis and the medial-lateral angles on y-axis. The equation for the gait symmetry will be based on the perpendicular distance of each point (representing the knee (or ankle) position) from the symmetry line and from origin on 2-D cyclogram plot.

    Measured: 6 Months

Secondary outcomes (1)
  1. Surface Electromyogram (EMG)

    EMG activation timing and amplitudes

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMay 2015
  4. Study completionApr 2016

Resources

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01952613
Sponsor's protocol ID
Kessler-RP-R03-1
Other IDs
1R03NS082950-01
Status last verified
Aug 2017
First submitted
24 Sep 2013
Last updated
21 Aug 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing FES in people with Stroke and Foot Drop, run by Kessler Foundation at 1 site in United States.

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 6 inclusion and 6 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: finished, as of the sponsor's last update on 21 Aug 2017. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait Symmetry (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 21 Aug 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in