Clinical trial NCT04266899: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Cerebrovascular Stroke
Cerebral Stroke
Cerebrovascular Accident
Neurorehabilitation
Gait Rehabilitation
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assessment of gait speed
timeFrame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Secondary outcomes:
measure: Assessment of angular kinematics of hip, knee and ankle
timeFrame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
measure: Changes in center of pressure displacement
timeFrame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
measure: Postural Control
timeFrame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
measure: Functional Mobility
timeFrame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
measure: Muscular tone assessed by the Modified Ashworth Scale
timeFrame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
measure: Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale
timeFrame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
measure: Assessment of Gait speed in external environment
timeFrame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
measure: Assessment of duration of stance and swing phase of gait
timeFrame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
measure: Assessment of Stride length and Step length of gait
timeFrame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
measure: Assessment of cadence by means number of steps by the minute.
timeFrame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
measure: Assessment of Harmonic Ration of Gait
timeFrame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Sciences of Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Health Sciences of Porto Alegre
name: Aline S Pagnussat, PhD
role: PRINCIPAL_INVESTIGATOR
References: