NCT01952613

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

2.1 years

First QC Date

September 24, 2013

Last Update Submit

August 16, 2017

Conditions

StrokeFoot Drop

Keywords

Foot dropFunctional Electrical Stimulation

Outcome Measures

Primary Outcomes (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.

    6 Months

Secondary Outcomes (1)

  • Surface Electromyogram (EMG)

    6 Months

Study Arms (1)

Stroke - FES

EXPERIMENTAL

Stroke population currently prescribed a FES orthotic device (\< week)

Device: FES

Interventions

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.

Stroke - FES

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

StrokePeroneal Neuropathies

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Officials

  • Rakesh Pilkar, PhD

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

September 24, 2013

First Posted

September 30, 2013

Study Start

April 1, 2013

Primary Completion

May 1, 2015

Study Completion

April 1, 2016

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations

US(1)