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

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 Overview

• Status: Unknown
• Conditions: Dropped Foot
• Intervention / Treatment: Device: FES

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sigal Portnoy, PhD; Phone Number: 0097225844492; Email: sigalp@hadassah.org.il

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Medical Organization
    • Contact: Sigal Portnoy, PhD; Phone Number: 0097225844492; Email: sigalp@hadassah.org.il
    • Sub-Investigator: Sigal Portnoy, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: FES; Other Names: Mygait
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in velocity of gait	Measured in m/s and the change will be in %	Baseline, 4 weeks and 12 week follwing baseline
Change in step length	Measured in cm and the change will be in %	Baseline, 4 and 12 weeks following baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait symmetry	Calculated symmetry of stance duration, swing duration, double support duration, step length, base width, and foot progression	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.	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.	At baseline, 4 and 12 weeks following baseline

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ANTICIPATED): June 1, 2017

Study Registration Dates

• First Submitted: May 2, 2013
• First Submitted That Met QC Criteria: June 10, 2013
• First Posted (ESTIMATE): June 12, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 3, 2016
• Last Update Submitted That Met QC Criteria: May 2, 2016
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Gait analysis; Functional electrical stimulation (FES); Sub acute stroke
• Other Study ID Numbers: MyGait-HMO-CTIL