N/A
Completed N=17
Clinical Algorithm for Post-Stroke Gait Training With C-Brace
Hemiparesis Due to Stroke · Hemiplegia Due to Stroke
Source: ClinicalTrials.gov NCT02892760 ↗
Enrolled (actual)
17
Serious AEs
6.7%
Results posted
Nov 2021
Primary outcomePrimary: Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis — 33.98; 9.34; 21.25; 34.51 degrees
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.
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 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 | — |
| 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 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 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 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 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 Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT) |
0.030 | — |
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
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. Informational only — not medical advice.