The Effect of Neuro-orthosis on Gait Performer in Post Stroke Subjects

Study Overview
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Brief Summary
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The aim of this study is to verify the effectiveness of foot drop stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild, moderate and severe compromise.

Detailed Description
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The stroke subjects are going to perform the walking training with Foot drop stimulator on the treadmill. All the evaluations will be performed with a foot drop stimulator turned off and on. One month later, that finished the intensive treatment; the participants were also evaluated only without the stimulation of FDS.

Official Title
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The Effect of Neuro-orthosis on Gait Performer in Chronic Post Stroke Subjects

Conditions
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Stroke

Intervention / Treatment
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* Device: Foot Drop Stimulator - Neuro Orthosis
* Device: Treadmill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with ischemic or hemorrhagic stroke diagnosis. Mild, moderate or severe hemiparesis (chronic stroke - at least 6 months) Minimal cognitive ability to understand commands Able to walk 10 meters unassisted or with minimal assistance Exclusion Criteria: Secondary musculoskeletal disorder involving the lower limb Contraindication for electrical stimulation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FDS+Treadmill gait training<br>Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Treadmill gait training during two weeks. | Device: Foot Drop Stimulator - Neuro Orthosis<br>* The WalkAide system is a self-contained functional electrical stimulation device with a built-in tilt sensor and attaches with a cuff to the leg below the knee. The device stimulates the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.<br>Device: Treadmill<br>* Gait training on a treadmill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of gait speed | Evaluated by means of the 3-D motion analysis system (capture system BTS SMART DX 400) | Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of angular kinematics of hip, knee and ankle | Evaluated by means of the 3-D motion analysis system (capture system BTS SMART DX 400) | Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up) | 
| Changes in center of pressure displacement | Assessed by force platform (BTS P-6000) | Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up) | 
| Postural Control | Evaluated by Center of Pressure (COP) displacement assessed on force platform (BTS P-6000) | Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up) | 
| Functional Mobility | Evaluated by means of the Timed Up & Go Test (TUG) | Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up) | 
| Muscular tone assessed by the Modified Ashworth Scale | Assessed by the Modified Ashworth Scale. This scale consists of 5 ordinal values ranging from 0 (no tonus increase) to 4 (stiffness). | Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up) | 
| Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale | Fugl-Meyer scale of lower limb impairment. The evaluation includes measurement of voluntary movement, velocity, coordination and reflex activity, through an ordinal scale applied to each item: 0- cannot be performed, 1- partially performed, and 2-performed completely. Participants were also classified according their LL motor impairment in severe (0 to19), moderate (20 to 28) or mild (> 29 points). | Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up) | 
| Assessment of Gait speed in external environment | Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy) during 10 meters walking test. | Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up) | 
| Assessment of duration of stance and swing phase of gait | Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy), during 10 meters walking test. | Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up) | 
| Assessment of Stride length and Step length of gait | Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy), during 10 meters walking test. | Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up) | 
| Assessment of cadence by means number of steps by the minute. | Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy), during 10 meters walking test. | Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up) | 
| Assessment of Harmonic Ration of Gait | Evaluated by means single miniaturized inertial sensor (G-Sensor®, BTS Bioengineering, Italy). The device collects the values of linear accelerations along three orthogonal axes (antero-posterior (AP) corresponding to the walking direction, medio-lateral (ML), and supero-inferior (V)). The Harmonic Ration is the ratio between the sum of the amplitudes of even harmonics and the sum of the amplitudes of odd harmonics calculated via the discrete Fourier transform along the antero-posterior (AP) and cranio-caudal (CC) directions; the opposite ratio is calculated along the latero-lateral axis (LL). | Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebrovascular Stroke, Cerebral Stroke, Cerebrovascular Accident, Neurorehabilitation, Gait Rehabilitation