Comparison of Different Treatment Methods for Gait Rehabilitation of Sub-Acute Post Stroke Patients With Dropped Foot

Hadassah Medical Organization40 enrolled

Overview

The investigators hypothesize that the gait pattern of following the utilization of a functional electrical stimulation device will be much improved when compared to the effect of regular gait re-education with ankle-foot-orthosis (AFO) fitting in patients in early stages following stroke.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dropped Foot

Interventions

FESDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Sub-acute stroke patients suffering a first stroke with clinical presentation, according to the WHO definitions * Patients suffering from unilateral foot drop * Independent ambulation before the stroke * Cognitive and cooperative ability to follow simple instructions * Neurological condition severity mild to moderate (between 3 and 15, according to the National Institutes of Health Stroke Scale; NIHSS). * Ability to walk with or without a walking aid (cane, walker), with or without assistance. Functional Ambulation Classification (FAC) of at least 2 * Independently capable to understand an informed consent form. Exclusion Criteria: * Cognitive disorders preventing the subject from understanding the trial protocol or following the researcher's instructions * Orthopaedic injury to the paretic or non-paretic limbs * Motor disability due to neurological diagnosis, e.g. multiple sclerosis, cerebral palsy, spinal cord injury, and Parkinson * Peripheral injury of the peroneal nerve or sciatic nerve * Pregnant or nursing females

Locations (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

Outcomes

Primary Outcomes

Change in velocity of gait

Measured in m/s and the change will be in %

Time frame: Baseline, 4 weeks and 12 week follwing baseline

Change in step length

Measured in cm and the change will be in %

Time frame: Baseline, 4 and 12 weeks following baseline

Secondary Outcomes

Gait symmetry

Calculated symmetry of stance duration, swing duration, double support duration, step length, base width, and foot progression

Time frame: Baseline, 4 and 12 weeks following baseline

Muscle activity patterns

Surface electromyography (EMG) electrodes will be attached to 6 muscles for evaluation of dynamic muscle activation pattern during gait without the intervention. Specifically, we will monitor the medial gastrocnemius, soleus and tibialis anterior, bilaterally.

Time frame: Baseline, 4 and 12 weeks following baseline

Functional assessment

Selective motor control during dorsiflexion will be tested with and without flexed knee according to the classification of three levels: normal, impaired, and unable. This test will be utilized for matching of the test group and control group. Physical evaluation will be conducted to assess the muscle tonus of the gastrocnemius, tibialis anterior and quadriceps according to Ashwart scale. Passive joint range of motion will also be assessed. Functional evaluation of each subject will be accomplished using the 10-meter walk. The Functional Ambulation Classification (FAC) will also be applied in order to obtain a patient prognosis level with regard to ambulation. Time up and Go (TUG) test will be performed in the in gait laboratory so that the performance of the subjects during the trials can be videotaped.

Time frame: At baseline, 4 and 12 weeks following baseline

Central Contacts

Sigal Portnoy, PhD

CONTACT

0097225844492 sigalp@hadassah.org.il

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572 lhadas@hadassah.org.il

Data from ClinicalTrials.gov

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