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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Foot Drop Stimulator - Neuro Orthosis; Device: Treadmill

• Registration Number: NCT04266899
• Lead Sponsor: Federal University of Health Science of Porto Alegre

Brief Summary

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

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 Timeline

• Study Start: 2019-09-20
• Primary Completion: 2019-09-20
• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-12
• Study Completion: 2020-03-20
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FDS+Treadmill gait training	Foot Drop Stimulator - Neuro Orthosis	Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Treadmill gait training during two weeks.
FDS+Treadmill gait training	Treadmill	Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Treadmill gait training during two weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assessment of cadence by means number of steps by the minute.	Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)	Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy), during 10 meters walking test.
Changes in center of pressure displacement	Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)	Assessed by force platform (BTS P-6000)
Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale	Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)	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).
Assessment of Stride length and Step length of gait	Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)	Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy), during 10 meters walking test.
Assessment of angular kinematics of hip, knee and ankle	Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)	Evaluated by means of the 3-D motion analysis system (capture system BTS SMART DX 400)
Muscular tone assessed by the Modified Ashworth Scale	Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)	Assessed by the Modified Ashworth Scale. This scale consists of 5 ordinal values ranging from 0 (no tonus increase) to 4 (stiffness).
Assessment of Gait speed in external environment	Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)	Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy) during 10 meters walking test.
Postural Control	Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)	Evaluated by Center of Pressure (COP) displacement assessed on force platform (BTS P-6000)
Functional Mobility	Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)	Evaluated by means of the Timed Up \& Go Test (TUG)
Assessment of duration of stance and swing phase of gait	Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)	Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy), during 10 meters walking test.
Assessment of Harmonic Ration of Gait	Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)	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).

Trial Locations

Locations (1)

Federal University of Health Sciences of Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil