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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04266899
• Other study ID #: FDS_Stroke
• Status: Completed
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: February 2021
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 20, 2020
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• Treadmill
Gait training on a treadmill

Locations

Country	Name	City	State
Brazil	Federal University of Health Sciences of Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)