Hemiparesis Due to StrokeNCT02892760
Clinical Algorithm for Post-Stroke Gait Training With C-Brace
A study testing C-Brace in people with Hemiparesis Due to Stroke and Hemiplegia Due to Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemiparesis Due to Stroke, Hemiplegia Due to Stroke
- What is being tested?
- C-Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2017to 8 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- C-Brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-BraceDevice
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
| Study group | Role | What they receive |
|---|---|---|
| with C-brace | Experimental | C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking. Receives: Device: C-Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: week 9
Secondary outcomes (31)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)].
Measured: 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)].
Measured: 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)].
Measured: 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)].
Measured: 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)].
Measured: 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)].
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)].
Measured: 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)].
Measured: 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)].
Measured: week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start13 Feb 2017
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemiparesis Due to StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Otto Bock Healthcare Products GmbH
- Responsible party
- Principal investigator, Gerard Francisco, The University of Texas Health Science Center, Houston
- Investigators
- Gerard Francisco, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892760
- Sponsor's protocol ID
- HSC-MS-16-0031
- Status last verified
- Oct 2021
- First submitted
- 2 Aug 2016
- Last updated
- 8 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Algorithm for Post-Stroke Gait Training With C-Brace
- ClinicalTrials.gov ID
- NCT02892760
- Acronym / sponsor ID
- HSC-MS-16-0031
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Otto Bock Healthcare Products GmbH
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Posted 8 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| with C-brace | Experimental | Device: C-BraceC-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-BraceC-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking. | Device | with C-brace |
Primary outcome
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Time frame: week 5
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).
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Time frame: week 9
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).
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Time frame: week 5
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).
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Time frame: week 9
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).
Metabolic Expenditure During Walking
Time frame: week 5
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.
Metabolic Expenditure During Walking
Time frame: week 9
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.
31 secondary outcomes
Score on the Timed Up and Go Test
Time frame: week 0
Score on the Timed Up and Go Test
Time frame: week 5
Score on the Timed Up and Go Test
Time frame: week 9
Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)
Time frame: week 0
Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)
Time frame: week 9
Change in Hip Flexors Strength as Assessed by Dynamometry
Time frame: week 0, week 9
Change in Hip Extensors Strength as Assessed by Dynamometry
Time frame: week 0, week 9
Change in Hip Abductors Strength as Assessed by Dynamometry
Time frame: week 0, week 9
Change in Hip Adductors Strength as Assessed by Dynamometry
Time frame: week 0, week 9
Change in Knee Flexors Strength as Assessed by Dynamometry
Time frame: week 0, week 9
Change in Knee Extensors Strength as Assessed by Dynamometry
Time frame: week 0, week 9
Change in Ankle Dorsiflexors Strength as Assessed by Dynamometry
Time frame: week 0, week 9
Change in Ankle Plantarflexors. Strength as Assessed by Dynamometry
Time frame: week 0, week 9
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Time frame: week 0
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Time frame: week 9
Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Time frame: week 0
Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Time frame: week 9
Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Time frame: week 0
Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Time frame: week 9
Motor Impairment as Determined by the Fugl-Meyer Assessment
Time frame: week 0
Motor Impairment as Determined by the Fugl-Meyer Assessment
Time frame: week 9
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Time frame: week 0
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Time frame: week 9
Static Balance as Assessed by the Berg Balance Scale (BBS)
Time frame: week 0
Static Balance as Assessed by the Berg Balance Scale (BBS)
Time frame: week 9
Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
Time frame: week 0
Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
Time frame: week 5
Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
Time frame: week 9
Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)
Time frame: week 0
Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)
Time frame: week 5
Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)
Time frame: week 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Francisco, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Brace in people with Hemiparesis Due to Stroke and Hemiplegia Due to Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis (time frame: week 5). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.