Clinical trial NCT02892760: Clinical Algorithm for Post-Stroke Gait Training With C-Brace
Official title: Clinical Algorithm for Post-Stroke Gait Training With C-Brace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis Due to Stroke
Hemiplegia Due to Stroke
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Otto Bock Healthcare Products GmbH
First posted: 2016-09-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
timeFrame: week 5
measure: Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
timeFrame: week 9
measure: Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
timeFrame: week 5
measure: Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
timeFrame: week 9
measure: Metabolic Expenditure During Walking
timeFrame: week 5
measure: Metabolic Expenditure During Walking
timeFrame: week 9
Secondary outcomes:
measure: Score on the Timed Up and Go Test
timeFrame: week 0
measure: Score on the Timed Up and Go Test
timeFrame: week 5
measure: Score on the Timed Up and Go Test
timeFrame: week 9
measure: Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)
timeFrame: week 0
measure: Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)
timeFrame: week 9
measure: Change in Hip Flexors Strength as Assessed by Dynamometry
timeFrame: week 0, week 9
measure: Change in Hip Extensors Strength as Assessed by Dynamometry
timeFrame: week 0, week 9
measure: Change in Hip Abductors Strength as Assessed by Dynamometry
timeFrame: week 0, week 9
measure: Change in Hip Adductors Strength as Assessed by Dynamometry
timeFrame: week 0, week 9
measure: Change in Knee Flexors Strength as Assessed by Dynamometry
timeFrame: week 0, week 9
measure: Change in Knee Extensors Strength as Assessed by Dynamometry
timeFrame: week 0, week 9
measure: Change in Ankle Dorsiflexors Strength as Assessed by Dynamometry
timeFrame: week 0, week 9
measure: Change in Ankle Plantarflexors. Strength as Assessed by Dynamometry
timeFrame: week 0, week 9
measure: Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
timeFrame: week 0
measure: Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
timeFrame: week 9
measure: Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry
timeFrame: week 0
measure: Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry
timeFrame: week 9
measure: Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry
timeFrame: week 0
measure: Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry
timeFrame: week 9
measure: Motor Impairment as Determined by the Fugl-Meyer Assessment
timeFrame: week 0
measure: Motor Impairment as Determined by the Fugl-Meyer Assessment
timeFrame: week 9
measure: Spasticity as Assessed by the Modified Ashworth Scale (MAS)
timeFrame: week 0
measure: Spasticity as Assessed by the Modified Ashworth Scale (MAS)
timeFrame: week 9
measure: Static Balance as Assessed by the Berg Balance Scale (BBS)
timeFrame: week 0
measure: Static Balance as Assessed by the Berg Balance Scale (BBS)
timeFrame: week 9
measure: Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
timeFrame: week 0
measure: Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
timeFrame: week 5
measure: Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
timeFrame: week 9
measure: Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)
timeFrame: week 0
measure: Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)
timeFrame: week 5
measure: Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)
timeFrame: week 9
Other outcomes:
Locations:
city: Houston
country: United States
facility: TIRR Research Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Gerard Francisco, MD
role: PRINCIPAL_INVESTIGATOR
References: