Dropped Foot
Conditions
Keywords
Functional electrical stimulation (FES), Sub acute stroke, Gait analysis
Brief summary
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.
Interventions
DEVICEFES
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in velocity of gait | Baseline, 4 weeks and 12 week follwing baseline | Measured in m/s and the change will be in % |
| Change in step length | Baseline, 4 and 12 weeks following baseline | Measured in cm and the change will be in % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait symmetry | Baseline, 4 and 12 weeks following baseline | Calculated symmetry of stance duration, swing duration, double support duration, step length, base width, and foot progression |
| Muscle activity patterns | Baseline, 4 and 12 weeks following baseline | 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. |
| Functional assessment | At baseline, 4 and 12 weeks following baseline | 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. |
Countries
Israel
Contacts
Primary ContactSigal Portnoy, PhD
Backup ContactHadas Lemberg, PhD
Outcome results
None listed