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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Foot Drop Stimulator - Neuro Orthosis
Treadmill
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Cerebrovascular Stroke, Cerebral Stroke, Cerebrovascular Accident, Neurorehabilitation, Gait Rehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Federal University of Health Sciences of Porto Alegre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FDS+Treadmill gait training

Arm Description

Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Treadmill gait training during two weeks.

Outcomes

Primary Outcome Measures

Assessment of gait speed
Evaluated by means of the 3-D motion analysis system (capture system BTS SMART DX 400)

Secondary Outcome Measures

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)
Changes in center of pressure displacement
Assessed by force platform (BTS P-6000)
Postural Control
Evaluated by Center of Pressure (COP) displacement assessed on force platform (BTS P-6000)
Functional Mobility
Evaluated by means of the Timed Up & Go Test (TUG)
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).
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).
Assessment of Gait speed in external environment
Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy) during 10 meters walking test.
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.
Assessment of Stride length and Step length of gait
Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy), during 10 meters walking test.
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.
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).

Full Information

First Posted
January 28, 2020
Last Updated
February 10, 2021
Sponsor
Federal University of Health Science of Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT04266899
Brief Title
The Effect of Neuro-orthosis on Gait Performer in Post Stroke Subjects
Official Title
The Effect of Neuro-orthosis on Gait Performer in Chronic Post Stroke Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Cerebrovascular Stroke, Cerebral Stroke, Cerebrovascular Accident, Neurorehabilitation, Gait Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FDS+Treadmill gait training
Arm Type
Experimental
Arm Description
Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Treadmill gait training during two weeks.
Intervention Type
Device
Intervention Name(s)
Foot Drop Stimulator - Neuro Orthosis
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Treadmill
Intervention Description
Gait training on a treadmill
Primary Outcome Measure Information:
Title
Assessment of gait speed
Description
Evaluated by means of the 3-D motion analysis system (capture system BTS SMART DX 400)
Time Frame
Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Secondary Outcome Measure Information:
Title
Assessment of angular kinematics of hip, knee and ankle
Description
Evaluated by means of the 3-D motion analysis system (capture system BTS SMART DX 400)
Time Frame
Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Title
Changes in center of pressure displacement
Description
Assessed by force platform (BTS P-6000)
Time Frame
Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Title
Postural Control
Description
Evaluated by Center of Pressure (COP) displacement assessed on force platform (BTS P-6000)
Time Frame
Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Title
Functional Mobility
Description
Evaluated by means of the Timed Up & Go Test (TUG)
Time Frame
Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Title
Muscular tone assessed by the Modified Ashworth Scale
Description
Assessed by the Modified Ashworth Scale. This scale consists of 5 ordinal values ranging from 0 (no tonus increase) to 4 (stiffness).
Time Frame
Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Title
Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale
Description
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).
Time Frame
Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Title
Assessment of Gait speed in external environment
Description
Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy) during 10 meters walking test.
Time Frame
Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Title
Assessment of duration of stance and swing phase of gait
Description
Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy), during 10 meters walking test.
Time Frame
Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Title
Assessment of Stride length and Step length of gait
Description
Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy), during 10 meters walking test.
Time Frame
Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Title
Assessment of cadence by means number of steps by the minute.
Description
Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy), during 10 meters walking test.
Time Frame
Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Title
Assessment of Harmonic Ration of Gait
Description
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).
Time Frame
Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aline S Pagnussat, PhD
Organizational Affiliation
Federal University of Health Sciences of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Health Sciences of Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

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

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