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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Foot Drop Stimulator - Neuro Orthosis; Device: Treadmill

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Federal University of Health Sciences of Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FDS+Treadmill gait training; Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Treadmill gait training during two weeks.	Device: Foot Drop Stimulator - Neuro Orthosis; 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.; Device: Treadmill; Gait training on a treadmill

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 20, 2019
• Primary Completion (ACTUAL): September 20, 2019
• Study Completion (ACTUAL): March 20, 2020

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (ACTUAL): February 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Cerebrovascular Accident; Neurorehabilitation; Cerebrovascular Stroke; Cerebral Stroke; Gait Rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: FDS_Stroke

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No