Upper Extremity Injection of Xeomin® and Changes in Gait Related Mobility in Adults After Stroke
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Instrumented Timed Up and Go test time
研究概览
简要总结
The aim of the present pilot study is to evaluate the association between change in gait related mobility in ambulatory male and female adult hemiparetic patients before and 4-6-weeks after Xeomin® injection into the upper limb, using two standardized tests of physical function in outpatient rehabilitation that are widely used; the 10-meter walk test and the timed 'up and go' test (TUG).
详细描述
For this pilot study, the investigators hypothesize that there will be durational improvements in gait related mobility on the instrumented TUG and 10-meter walk tests 4-6-weeks post upper extremity Xeomin® injection. Physical function will be quantified as time to complete the instrumented TUG.
A one-group pretest-post-test experimental design will be used. Participants will be tested on the primary and secondary outcome measures before upper extremity injection with Xeomin® and 4 to 6 weeks thereafter. Additionally, participants will be contacted for an end of study visit via telephone approximately 12-weeks post Xeomin® injection to obtain information regarding any adverse events and gain insight into the therapeutic duration of the Xeomin®. The proposed duration of the study is 2 years to allow adequate time for screening, recruitment and follow-up.
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
盲法说明
To assess if Xeomin® injection into the hemiparetic arm is associated with changes in hemiparetic elbow range of motion, a blinded investigator will visually observe the position of the injected arm during their 10-meter walk test, using video tape sequences of the pre- and post-test gait analysis sessions.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hemiparesis and spasticity secondary to stroke with upper and lower limb spasticity and unilateral motor and/or sensory deficit
- •No prior surgery to the lower limb
- •Able to walk at least 10 meters without physical assistance from another person and without an assistive device
- •Toe- ground clearance during swing phase without assistive device or orthoses
- •No treatment with botulinum toxin within the past 4 months
排除标准
- •Passive range of motion at either the ankle, knee, or elbow joint less than 30 degrees
- •Participants with uncorrected hearing impairment
- •Weight bearing restrictions due to concurrent orthopedic injuries that would make ambulating with or without an assistive device unsafe
- •Speech language expression deficit (e.g., aphasia)
- •Absence of proprioception upon neurologic examination
- •Presence of fixed contractures in the upper or lower extremities not correctable to neutral
- •Other confounding neurological diagnoses or active acute illness (cancer, Parkinson's disease, multiple sclerosis)
研究组 & 干预措施
Xeomin®
Participants will be injected via electromyographic guidance with a total of 200 units of Xeomin® into the pectoralis major, biceps brachii, brachioradialis, and latissimus dorsi muscles of the hemiparetic side using a standardized injection protocol (16). An additional 100 units of Xeomin® will be available at the discretion of the investigator for injection into additional affected upper extremity muscles
干预措施: Xeomin® (Drug)
结局指标
主要结局
Change in Instrumented Timed Up and Go test time
时间窗: Baseline and 4-6 weeks after Xeomin injection
Subjects arise from a chair, walk at their normal speed, turn around right after passing the tape at the end of the pathway, return to the chair, turn around and sit down. Subjects will be fitted with a , single Attitude and heading reference system (AHRS) sensor fixed on the manubrium inferior to the interclavicular notch in a chest-mounted pack. The AHRS is a wireless-telemetry, 10-parameter unit which includes a tri-axial accelerometer, a tri-axial gyroscope, a tri-axial magnetometer and an onboard temperature sensor.
次要结局
- Change in Berg Balance Scale (BBS) score(Baseline and 4-6 weeks after Xeomin injection)
- Change in Modified Ashworth Scale (MAS) score(Baseline and 4-6 weeks after Xeomin injection)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) General Life Satisfaction - Short Form 5a score(Baseline and 4-6 weeks after Xeomin injection)
- Change in Neuro-QoL Satisfaction with Social Roles and Activities - Short Form score(Baseline and 4-6 weeks after Xeomin injection)
- Change in Quality of Life in Neurological Disorders (Neuro-QoL) Depression - Short Form score(Baseline and 4-6 weeks after Xeomin injection)
- Change in Brief Pain Inventory (BPI) - Short Form score(Baseline and 4-6 weeks after Xeomin injection)
- Change in Mini-Mental State Examination score(Baseline and 4-6 weeks after Xeomin injection)
- Change in Ten-meter walk test time(Baseline and 4-6 weeks after Xeomin injection)
- Change in Activities-Specific Balance (ABC) Scale score(Baseline and 4-6 weeks after Xeomin injection)