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

Hadassah Medical Center

Status: Unknown

Conditions: Dropped Foot

Treatments: Device: FES

Study type: Interventional

Funder types: Other

Identifiers

NCT01876030

MyGait-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

FES

Experimental group

Description:

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.

Treatment:

Device: FES

Conventional

No Intervention group

Description:

Treated with regular gait re-education with or without AFO fitting. 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 AFO 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.