Clinical Algorithm for Post-Stroke Gait Training With C-Brace
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
时间窗: 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).
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
时间窗: 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).
Metabolic Expenditure During Walking
时间窗: 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.
次要结局
- Score on the Timed Up and Go Test(week 9)
- Change in Hip Flexors Strength as Assessed by Dynamometry(week 0, week 9)
- Change in Ankle Plantarflexors. Strength as Assessed by Dynamometry(week 0, week 9)
- Change in Ankle Dorsiflexors Strength as Assessed by Dynamometry(week 0, week 9)
- Change in Hip Adductors Strength as Assessed by Dynamometry(week 0, week 9)
- Change in Knee Flexors Strength as Assessed by Dynamometry(week 0, week 9)
- Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)(week 9)
- Change in Hip Abductors Strength as Assessed by Dynamometry(week 0, week 9)
- Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)(week 9)
- Change in Knee Extensors Strength as Assessed by Dynamometry(week 0, week 9)
- Change in Hip Extensors Strength as Assessed by Dynamometry(week 0, week 9)
- Motor Impairment as Determined by the Fugl-Meyer Assessment(week 9)
- Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry(week 9)
- Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry(week 9)
- Spasticity as Assessed by the Modified Ashworth Scale (MAS)(week 9)
- Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)(week 9)
- Static Balance as Assessed by the Berg Balance Scale (BBS)(week 9)
- Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry(week 9)
研究者
Gerard Francisco
Professor and Chairman of Physical Medicine and Rehabilitation
The University of Texas Health Science Center, Houston