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

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.

Study Overview

• Status: Completed
• Conditions: Hemiparesis Due to Stroke; Hemiplegia Due to Stroke
• Intervention / Treatment: Device: C-Brace

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • TIRR Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: with C-brace; C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.	Device: C-Brace; C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on the Timed Up and Go Test	Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity.	week 0
Score on the Timed Up and Go Test	Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity.	week 5
Score on the Timed Up and Go Test	Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity.	week 9
Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)	Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction. Several studies report acceptable validity of MMSE as a screening instrument and its relationship to functional outcome in stroke population. Total score ranges from 0 to 30, with a higher score indicating a better outcome.	week 0
Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)	Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction. Several studies report acceptable validity of MMSE as a screening instrument and its relationship to functional outcome in stroke population. Total score ranges from 0 to 30, with a higher score indicating a better outcome.	week 9
Change in Hip Flexors Strength as Assessed by Dynamometry	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip flexors.	week 0, week 9
Change in Hip Extensors Strength as Assessed by Dynamometry	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip extensors.	week 0, week 9
Change in Hip Abductors Strength as Assessed by Dynamometry	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip abductors.	week 0, week 9
Change in Hip Adductors Strength as Assessed by Dynamometry	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip adductors.	week 0, week 9
Change in Knee Flexors Strength as Assessed by Dynamometry	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as knee flexors.	week 0, week 9
Change in Knee Extensors Strength as Assessed by Dynamometry	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as knee extensors.	week 0, week 9
Change in Ankle Dorsiflexors Strength as Assessed by Dynamometry	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as ankle dorsiflexors.	week 0, week 9
Change in Ankle Plantarflexors. Strength as Assessed by Dynamometry	Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as ankle plantarflexors.	week 0, week 9
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry	Range of motion will be measured on bilateral hip using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected hip will be measured and also the range of motion of their other hip (the unaffected hip) will be measured [it is possible that a participant will have a range of motion within normal limits on both hip sides (affected hip and unaffected hip)].	week 0
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry	Range of motion will be measured on bilateral hip using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected hip will be measured and also the range of motion of their other hip (the unaffected hip) will be measured [it is possible that a participant will have a range of motion within normal limits on both hip sides (affected hip and unaffected hip)].	week 9
Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry	Range of motion will be measured on knee joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected knee will be measured and also the range of motion of their other knee (the unaffected knee) will be measured [it is possible that a participant will have a range of motion within normal limits for both knees (affected knee and unaffected knee)].	week 0
Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry	Range of motion will be measured on knee joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected knee will be measured and also the range of motion of their other knee (the unaffected knee) will be measured [it is possible that a participant will have a range of motion within normal limits for both knees (affected knee and unaffected knee)].	week 9
Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry	Range of motion will be measured on ankle joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected ankle will be measured and also the range of motion of their other ankle (the unaffected ankle) will be measured [it is possible that a participant will have a range of motion within normal limits for both ankles (affected ankle and unaffected ankle)].	week 0
Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry	Range of motion will be measured on ankle joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected ankle will be measured and also the range of motion of their other ankle (the unaffected ankle) will be measured [it is possible that a participant will have a range of motion within normal limits for both ankles (affected ankle and unaffected ankle)].	week 9
Motor Impairment as Determined by the Fugl-Meyer Assessment	The Fugl-Meyer Assessment evaluates and measures recovery of movement in individual post stroke. The Fugl-Meyer has been used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the balance component, for a total of 24 items. Each of the 24 items is scored as 0 (cannot perform), 1 (can perform partially), or 2 (can perform fully), with a total score ranging from 0 to 48, with a higher score indicating less impairment.	week 0
Motor Impairment as Determined by the Fugl-Meyer Assessment	The Fugl-Meyer Assessment evaluates and measures recovery of movement in individual post stroke. The Fugl-Meyer has been used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the balance component, for a total of 24 items. Each of the 24 items is scored as 0 (cannot perform), 1 (can perform partially), or 2 (can perform fully), with a total score ranging from 0 to 48, with a higher score indicating less impairment.	week 9
Spasticity as Assessed by the Modified Ashworth Scale (MAS)	This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in lower limbs.	week 0
Spasticity as Assessed by the Modified Ashworth Scale (MAS)	This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in lower limbs.	week 9
Static Balance as Assessed by the Berg Balance Scale (BBS)	A 14-item objective measure designed to assess static balance and fall risk in adult populations, with a total score range of 0 to 56 (higher scores represent better functional outcome). This test has been widely used to measure functional recovery in stroke patients with high reliability.	week 0
Static Balance as Assessed by the Berg Balance Scale (BBS)	A 14-item objective measure designed to assess static balance and fall risk in adult populations, with a total score range of 0 to 56 (higher scores represent better functional outcome). This test has been widely used to measure functional recovery in stroke patients with high reliability.	week 9
Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)	Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk.	week 0
Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)	Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk.	week 5
Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)	Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk.	week 9
Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)	The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked [milliliters/kilogram/minute/meter (mL/kg/min/m)].	week 0
Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)	The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked [milliliters/kilogram/minute/meter (mL/kg/min/m)].	week 5
Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)	The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked [milliliters/kilogram/minute/meter (mL/kg/min/m)].	week 9

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): January 8, 2019
• Study Completion (Actual): January 8, 2019

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Hemiplegia; Paresis
• Other Study ID Numbers: HSC-MS-16-0031

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes