Clinical Algorithm for Post-Stroke Gait Training With C-Brace

The University of Texas System (UT)

Status: Completed

Conditions: Hemiparesis Due to Stroke; Hemiplegia Due to Stroke

Treatments: Device: C-Brace

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02892760

HSC-MS-16-0031

Details and patient eligibility

About

The purpose of this study is to develop a clinical algorithmic-based evaluation and treatment approach for C-Brace for use by persons with hemiparesis or hemiplegia due to stroke.

Enrollment: 17 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 - 65 years
• 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

• Weight > 275 lbs. (Includes body weight and weight of heaviest object carried)
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

with C-brace

Experimental group

Description:

C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.

Treatment:

Device: C-Brace