Clinical Algorithm for Post-Stroke Gait Training With C-Brace
NCT ID: NCT02892760
Last Updated: 2021-11-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2017-02-13
2019-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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with C-brace
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
Interventions
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C-Brace
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of hemiparesis or hemiplegia following stroke
* Presence of abnormal walking pattern
* Poor knee control during stance phase
* Cognitive ability to (or care provider) manage daily charging of battery
* Cognitive ability to follow commands
* Hip flexor muscle strength grade 3 or greater or the ability to perform reciprocal gait using compensatory patterns
Exclusion Criteria
* Less than 2° of ankle motion
* Severe spasticity of the quadriceps (MAS \>3) and/or uncontrolled spasticity of the quadriceps
* Severe spasticity of other lower limb muscles (MAS \>3)
* Fixed genuvalgum exceeding 10° beyond anatomic neutral valgum
* Any fixed genuvarum exceeding anatomic neutral varum.
* Hip or knee flexion contractures greater than 10°
* Presence of chronic obstructive pulmonary disease (COPD)
* Chronic heart failure - New York Heart Association (NYHA) stages 3 and 4
18 Years
65 Years
ALL
No
Sponsors
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Otto Bock Healthcare Products GmbH
INDUSTRY
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Gerard Francisco
Professor and Chairman of Physical Medicine and Rehabilitation
Principal Investigators
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Gerard Francisco, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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TIRR Research Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-MS-16-0031
Identifier Type: -
Identifier Source: org_study_id