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

NCT ID: NCT01876030

Last Updated: 2016-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Brief Summary

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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

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Conditions

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Dropped Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

FES

Intervention Type DEVICE

Conventional

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FES

Intervention Type DEVICE

Other Intervention Names

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Mygait

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Sigal Portnoy, PhD

Role: CONTACT

0097225844492

Hadas Lemberg, PhD

Role: CONTACT

00 972 2 6777572

Facility Contacts

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Sigal Portnoy, PhD

Role: primary

0097225844492

Hadas Lemberg, PhD

Role: backup

00 972 2 6777572

Other Identifiers

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MyGait-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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