N/A N=17 Treatment

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

Hemiparesis Due to Stroke · Hemiplegia Due to Stroke

Bottom Line

View on ClinicalTrials.gov: NCT02892760 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

Nov 2021

Primary outcome: Primary: Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis — 33.98; 9.34; 21.25; 34.51 degrees

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: C-Brace (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Jan 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	38.80; 9.03; 22.75; 34.93; 7.92; 16.18	—
PRIMARY Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis	38.80; 9.03; 22.75; 34.93; 7.92; 16.18	—
PRIMARY Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	0.2639; 0.2776; 0.3312; 0.2149; 0.2146; 0.2795	—
PRIMARY Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)	0.2639; 0.2776; 0.3312; 0.2149; 0.2146; 0.2795	—
PRIMARY Metabolic Expenditure During Walking	0.03	—
PRIMARY Metabolic Expenditure During Walking	0.03	—
SECONDARY Score on the Timed Up and Go Test	19.09	—
SECONDARY Score on the Timed Up and Go Test	19.09	—
SECONDARY Score on the Timed Up and Go Test	19.09	—
SECONDARY Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)	28.43	—
SECONDARY Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)	28.43	—
SECONDARY Change in Hip Flexors Strength as Assessed by Dynamometry	—	—
SECONDARY Change in Hip Extensors Strength as Assessed by Dynamometry	—	—
SECONDARY Change in Hip Abductors Strength as Assessed by Dynamometry	—	—
SECONDARY Change in Hip Adductors Strength as Assessed by Dynamometry	—	—
SECONDARY Change in Knee Flexors Strength as Assessed by Dynamometry	—	—
SECONDARY Change in Knee Extensors Strength as Assessed by Dynamometry	—	—
SECONDARY Change in Ankle Dorsiflexors Strength as Assessed by Dynamometry	—	—
SECONDARY Change in Ankle Plantarflexors. Strength as Assessed by Dynamometry	—	—
SECONDARY Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry	13; 11; 12; 11; 13; 14	—
SECONDARY Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry	13; 11; 12; 11; 13; 14	—
SECONDARY Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry	12; 14; 14; 14	—
SECONDARY Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry	12; 14; 14; 14	—
SECONDARY Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry	6; 12; 14; 14	—
SECONDARY Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry	6; 12; 14; 14	—
SECONDARY Motor Impairment as Determined by the Fugl-Meyer Assessment	24.29	—
SECONDARY Motor Impairment as Determined by the Fugl-Meyer Assessment	24.29	—
SECONDARY Spasticity as Assessed by the Modified Ashworth Scale (MAS)	0.18; 0.07; 0.32; 0.64; 0; 0.57	—
SECONDARY Spasticity as Assessed by the Modified Ashworth Scale (MAS)	0.18; 0.07; 0.32; 0.64; 0; 0.57	—
SECONDARY Static Balance as Assessed by the Berg Balance Scale (BBS)	49.79	—
SECONDARY Static Balance as Assessed by the Berg Balance Scale (BBS)	49.79	—
SECONDARY Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)	0.73	—
SECONDARY Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)	0.73	—
SECONDARY Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)	0.73	—
SECONDARY Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)	0.030	—
SECONDARY Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)	0.030	—
SECONDARY Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)	0.030	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02892760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.