The University of Texas Health Science Center, Houston
Who can join
Adults 18 to 65, any sex, with Hemiparesis Due to Stroke or Hemiplegia Due to Stroke. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic AnalysisPrimary· 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 t
Affected Hip flexion-extension
Group
Value
95% CI
With C-brace
33.98
± 10.03
Affected Hip abduction-adduction
Group
Value
95% CI
With C-brace
9.34
± 3.04
Affected Hip internal-external rotation
Group
Value
95% CI
With C-brace
21.25
± 14.45
Affected Knee flexion-extension
Group
Value
95% CI
With C-brace
34.51
± 16.55
Affected Knee abduction-adduction
Group
Value
95% CI
With C-brace
7.72
± 1.77
Affected Knee internal-external rotation
Group
Value
95% CI
With C-brace
16.26
± 9.53
Affected Ankle flexion-extension
Group
Value
95% CI
With C-brace
13.51
± 7.73
Affected Ankle abduction-adduction
Group
Value
95% CI
With C-brace
6.06
± 4.33
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic AnalysisPrimary· 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
Affected Hip flexion-extension
Group
Value
95% CI
With C-brace
38.80
± 11.26
Affected Hip abduction-adduction
Group
Value
95% CI
With C-brace
9.03
± 3.55
Affected Hip internal-external rotation
Group
Value
95% CI
With C-brace
22.75
± 15.71
Affected Knee flexion-extension
Group
Value
95% CI
With C-brace
34.93
± 17.02
Affected Knee abduction-adduction
Group
Value
95% CI
With C-brace
7.92
± 2.93
Affected Knee internal-external rotation
Group
Value
95% CI
With C-brace
16.18
± 7.71
Affected Ankle flexion-extension
Group
Value
95% CI
With C-brace
15.91
± 6.82
Affected Ankle abduction-adduction
Group
Value
95% CI
With C-brace
6.82
± 5.51
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)Primary· 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).
Affected Tibialis anterior
Group
Value
95% CI
With C-brace
0.2627
± 0.0914
Affected Soleus
Group
Value
95% CI
With C-brace
0.2484
± 0.0641
Affected Medial gastrocnemius
Group
Value
95% CI
With C-brace
0.2183
± 0.1011
Affected Vastus medialis
Group
Value
95% CI
With C-brace
0.2211
± 0.0837
Affected Rectus femoris
Group
Value
95% CI
With C-brace
0.2513
± 0.0607
Affected Biceps femoris
Group
Value
95% CI
With C-brace
0.3136
± 0.0723
Affected Semimembranous
Group
Value
95% CI
With C-brace
0.2184
± 0.0734
Unaffected Tibialis anterior
Group
Value
95% CI
With C-brace
0.2791
± 0.0595
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)Primary· 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).
Affected Tibialis anterior
Group
Value
95% CI
With C-brace
0.2639
± 0.0897
Affected Soleus
Group
Value
95% CI
With C-brace
0.2776
± 0.0755
Affected Medial gastrocnemius
Group
Value
95% CI
With C-brace
0.3312
± 0.0950
Affected Vastus medialis
Group
Value
95% CI
With C-brace
0.2149
± 0.1062
Affected Rectus femoris
Group
Value
95% CI
With C-brace
0.2146
± 0.1072
Affected Biceps femoris
Group
Value
95% CI
With C-brace
0.2795
± 0.0905
Affected Semimembranous
Group
Value
95% CI
With C-brace
0.2781
± 0.1045
Unaffected Tibialis anterior
Group
Value
95% CI
With C-brace
0.3152
± 0.0689
Metabolic Expenditure During WalkingPrimary· 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 normall
Group
Value
95% CI
With C-brace
0.03
± 0.02
Metabolic Expenditure During WalkingPrimary· 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 normall
Group
Value
95% CI
With C-brace
0.03
± 0.01
Score on the Timed Up and Go TestSecondary· week 0
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.
Group
Value
95% CI
With C-brace
20.09
± 12.38
Score on the Timed Up and Go TestSecondary· week 5
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.
Group
Value
95% CI
With C-brace
19.37
± 9.13
Score on the Timed Up and Go TestSecondary· week 9
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.
Group
Value
95% CI
With C-brace
19.09
± 9.75
Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)Secondary· week 0
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.
Group
Value
95% CI
With C-brace
28.50
± 2.14
Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)Secondary· week 9
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.
Group
Value
95% CI
With C-brace
28.43
± 2.65
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by GoniometrySecondary· week 0
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 \[it is possible that a participant will have a range of motion within normal limits on both hip sides (affected hip and unaffected hip)\].
Affected side hip flexion
Group
Value
95% CI
With C-brace
12
Affected side hip extension
Group
Value
95% CI
With C-brace
11
Affected side hip internal rotation
Group
Value
95% CI
With C-brace
13
Affected side hip external rotation
Group
Value
95% CI
With C-brace
13
Affected side hip abduction
Group
Value
95% CI
With C-brace
12
Affected side hip adduction
Group
Value
95% CI
With C-brace
14
Unaffected side hip flexion
Group
Value
95% CI
With C-brace
13
Unaffected side hip extension
Group
Value
95% CI
With C-brace
13
Adverse events — posted to ClinicalTrials.gov
Time frame: 23 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT03906656 — Clinical Trial Comparing C-Brace to Knee Ankle Foot Orthosis (KAFO)/Stance Control Orthosis (SCO)
· NA
· completed
Other The University of Texas Health Science Center, Houston trials
Trials by the same sponsor.
NCT04200729 — Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-cente
· Phase 4
· not yet recruiting
NCT07225062 — Improving HIV Prevention and Substance Use Post-Sexual Assault Services
· NA
· not yet recruiting
NCT07396974 — Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT)
· NA
· not yet recruiting
NCT07170163 — Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families
· NA
· not yet recruiting
NCT06915441 — Lipid Infusions to Optimize Nutrition Trial
· Phase 2
· not yet recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The University of Texas Health Science Center, Houston
Last refreshed: 8 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02892760.