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

NCT02892760 | Completed Results FDA Device

• 1 other identifier: HSC-MS-16-0031
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemiparesis Due to Stroke; Hemiplegia Due to Stroke

Outcome Measures

Primary Outcomes (6)

• Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis

  During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the Northern Digital Inc (NDI) Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body).

  week 5

• Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis

  During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the NDI Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body).

  week 9

• Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)

  Bipolar surface electrodes will be placed on the bilateral major leg muscles to record electromyography (1000Hz, Motion Labs 16-Channel EMG System). The EMG amplitude (in volts) will be calculated over the whole gait cycle during the 10 Meter Walk Test (10MWT), in which the participant walks 10 meters. After stroke, one side of the body is affected, and data for various muscles are reported for both sides of the body (affected side of body and unaffected side of body).

  week 5

• Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)

  Bipolar surface electrodes will be placed on the bilateral major leg muscles to record electromyography (1000Hz, Motion Labs 16-Channel EMG System). The EMG amplitude (in volts) will be calculated over the whole gait cycle during the 10 Meter Walk Test (10MWT), in which the participant walks 10 meters. After stroke, one side of the body is affected, and data for various muscles are reported for both sides of the body (affected side of body and unaffected side of body).

  week 9

• Metabolic Expenditure During Walking

  Change in metabolic expenditure during walking will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.

  week 5

• Metabolic Expenditure During Walking

  Change in metabolic expenditure during walking will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.

  week 9

Secondary Outcomes (31)

• Score on the Timed Up and Go Test

  week 0

• Score on the Timed Up and Go Test

  week 5

• Score on the Timed Up and Go Test

  week 9

• Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)

  week 0

• Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)

  week 9

Study Arms (1)

with C-brace

EXPERIMENTAL

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

Device: C-Brace

Interventions

C-Brace DEVICE

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

with C-brace

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Otto Bock Healthcare Products GmbH: collaborator

Study Sites (1)

TIRR Research Center

Houston, Texas, 77030, United States

Location

Results Point of Contact

• Title: Gerard Francisco, MD
• Organization: The University of Texas Health Science Center at Houston

Gerard.E.Francisco@uth.tmc.edu

713-797-7636

Study Officials

• Gerard Francisco, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Professor and Chairman of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: September 8, 2016
• Study Start: February 13, 2017
• Primary Completion: January 8, 2019
• Study Completion: January 8, 2019
• Last Updated: November 8, 2021
• Results First Posted: November 8, 2021

Record last verified: 2021-10

Locations

US (1)