Stroke Clinical Trial
Official title:
Identification of Responders to the FES Interventions in Stroke Population
Verified date | August 2017 |
Source | Kessler Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | April 2016 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Kessler Foundation | West Orange | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Kessler Foundation | National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Surface Electromyogram (EMG) | EMG activation timing and amplitudes | 6 Months |
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