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

NCT04266899 | Completed

• 1 other identifier: FDS_Stroke
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Cerebrovascular Stroke; Cerebral Stroke; Cerebrovascular Accident; Neurorehabilitation; Gait Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Assessment of angular kinematics of hip, knee and ankle

  Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)

• Changes in center of pressure displacement

  Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)

• Postural Control

  Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)

• Functional Mobility

  Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)

• Muscular tone assessed by the Modified Ashworth Scale

  Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)

Study Arms (1)

FDS+Treadmill gait training

EXPERIMENTAL

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

Device: Foot Drop Stimulator - Neuro Orthosis; Device: Treadmill

Interventions

Foot Drop Stimulator - Neuro Orthosis DEVICE

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.

FDS+Treadmill gait training

Treadmill DEVICE

Gait training on a treadmill

FDS+Treadmill gait training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Secondary musculoskeletal disorder involving the lower limb
• Contraindication for electrical stimulation

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Stroke

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Aline S Pagnussat, PhD

  Federal University of Health Sciences of Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 12, 2020
• Study Start: September 20, 2019
• Primary Completion: September 20, 2019
• Study Completion: March 20, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

BR (1)