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Completed

NCT Number: NCT04266899

The Effect of Neuro-orthosis on Gait Performer in 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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Treadmill

Device

Gait training on a treadmill

Primary outcomes

  1. Assessment of gait speed

    Time frame: 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 outcomes

  1. Assessment of angular kinematics of hip, knee and ankle

    Time frame: 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)

  2. Changes in center of pressure displacement

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

    Assessed by force platform (BTS P-6000)

  3. Postural Control

    Time frame: 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)

  4. Functional Mobility

    Time frame: 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)

  5. Muscular tone assessed by the Modified Ashworth Scale

    Time frame: 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).

  6. Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale

    Time frame: 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).

  7. Assessment of Gait speed in external environment

    Time frame: 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.

  8. Assessment of duration of stance and swing phase of gait

    Time frame: 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.

  9. Assessment of Stride length and Step length of gait

    Time frame: 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.

  10. Assessment of cadence by means number of steps by the minute.

    Time frame: 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.

  11. Assessment of Harmonic Ration of Gait

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 12, 2020
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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