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

Not Applicable

• Conditions: Dropped Foot
• Interventions: Device: FES

• Registration Number: NCT01876030
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-04
• Study First Submitted: 2013-05-02
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-10
• Study First Posted: 2013-06-12
• Last Update Submitted: 2016-05-02
• Last Update Posted: 2016-05-03
• Primary Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FES	FES	All subjects will receive a 15-30 minutes a day treatment for 5 days a week. When the subjects achieves the ability to walk with supervision, but with no physical assistance, safely and consistently during the physiotherapy sessions, then either the FES will be provided to the subject to allow ongoing gait practice with the nursing staff in the ward environment. After discharge, the assistive device will be provided for home usage till the end of the research.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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.

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel