Comparison of Two High-intensity Gait Training Interventions on Contraversive Pushing Behaviors in Individuals Poststroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in Scale for Contraversive Pushing
研究概览
简要总结
The purpose of this study is to investigate the effect of two high-intensity gait training interventions on contraversive pushing behaviors in individuals poststroke in the acute inpatient rehabilitation setting. We will also evaluate the effect of these interventions on functional mobility, strength, balance, and endurance. Furthermore, we intend to measure therapist burden when mobilizing individuals with contraversive pushing behaviors.
详细描述
High-intensity gait training is strongly supported in individuals poststroke to facilitate neuroplastic changes in the brain in order to maximize the recovery of functional independence. Individuals with contraversive pushing behaviors (CPB) poststroke are difficult to mobilize as a result of tilted posture with significant balance impairments, a tendency to push toward their hemiparetic side, and resistance to external correction. CPB has been reported in 12-18% of individuals receiving stroke rehabilitation and often leads to longer lengths of stay, poorer functional outcomes, and institutionalized discharge locations compared to individuals poststroke without CPB.
High quality evidence guiding physical therapy intervention, specifically gait training, in individuals with CPB is scarce. Traditional therapeutic interventions in individuals with CPB consists of progressing functional mobility while orienting to midline with various forms of visual and tactile feedback. To further guide best practice in this population, we plan to investigate the effect of two high-intensity gait training interventions on CPB in 10 individuals poststroke in the acute inpatient rehabilitation setting over the course of one year.
Individuals from the inpatient stroke unit at the Shirley Ryan AbilityLab will be recruited and placed into one of two intervention groups. Intervention for group one will consist of body-weight-supported treadmill training + overground gait training. Intervention for group two will consist of gait training in the EksoNR exoskeleton + overground gait training. The commercially available EksoNR is approved by the FDA for use in individuals with stroke diagnoses. We will also evaluate the effect of these interventions on functional outcomes including mobility, strength, balance, walking speed, and walking endurance in addition to measuring therapist burden when mobilizing individuals with CPB.
Both groups will receive their specified gait training intervention three sessions a week for at least three weeks until they discharge with the goal of maximizing the number of steps within a 60 minute session. Gait training interventions will be progressed to challenge individuals as appropriate in order to reach 70-85% of age-predicted maximum heart rate. A fourth session will be utilized to assess weekly outcome measures as part of the standard of care at the Shirley Ryan AbilityLab. There will be no restrictions set on therapy delivered outside of these intervention training sessions as individuals will be getting other therapies each day as the standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old
- •Unilateral, supratentorial ischemic or hemorrhagic stroke within the past six months
- •Medical clearance from primary medical team (signed Medical Clearance form)
- •Contraversive pushing behaviors as determined by a score of >0 on the Scale for Contraversive Pushing
- •Adequate cognitive function as determined by the NIH scale: score ≤1 on question 1b and score =0 on question 1c
- •Informed consent provided by participant or power of attorney
- •English speaking
排除标准
- •Severe aphasia limiting ability to express needs or discomfort verbally or nonverbally
- •Severe behavioral neglect as determined by a score of ≥ 21 on Catherine Bergego Scale (CBS) via the Kessler Foundation-Neglect Assessment Process (KF-NAP)16
- •History of prior stroke
- •Concurrent neurologic condition (i.e PD, TBI, MS, etc.)
- •History of peripheral nerve injury
- •Joint contracture or significant spasticity in the lower limbs (Modified Ashworth Scale ≥3)
- •Severe knee, hip, or ankle osteoarthritis
- •Severe osteoporosis as indicated by physician medical clearance
- •Open wounds on surfaces in contact with exoskeleton or harness
- •Unstable spine or unhealed fractures
- •Weight bearing precautions
- •Unresolved deep vein thrombosis (DVT)
- •Concurrent participation in other lower limb research studies that according to the PI is likely to affect study outcome or confound results
- •Pregnancy
- •EksoNR Exclusion Criteria:
- •Weight >220 lbs (100 kg)
- •Height below 60 inches or above 76 inches
- •Standing hip width of approximately 18 inches or more
- •Joint contractures or range of motion deficits that limit normal range of motion during ambulation
- •Knee flexion contracture greater than 12°
- •Hip flexion contracture greater than 17°
- •Inability to achieve 0° neutral ankle dorsiflexion with knee flexion up to 12°
- •Bilateral hip flexion less than 110°
- •Leg length discrepancy
- •Greater than 0.5 in. (1.27 cm) for upper legs
- •Greater than 0.75 in. (1.91 cm) for lower legs
- •Active heterotopic ossification
- •Significant spasticity in the lower limbs (Modified Ashworth Scale ≥3)
- •High anxiety or claustrophobia
- •Clostridium difficile or other gastrointestinal isolation precautions
- •Colostomy
- •Uncontrolled autonomic dysreflexia
- •Lower limb prosthesis
结局指标
主要结局
Change in Scale for Contraversive Pushing
时间窗: Baseline, 3 weeks
The Scale for Contraversive Pushing is a three-item test used to measure lateropulsion also known as contraversive pushing behaviors. It is scored on a three point ordinal scale. It rates a participant's action/reaction of maintaining or changing a position in both sitting and standing. A score \>0 in each section indicates the presence of contraversive pushing behaviors. The maximum score is 6. The minimum score is 0, indicating an absence of pushing behaviors. The lower the score, the better.
Change in Burke Lateropulsion Scale
时间窗: Baseline, 3 weeks
The Burke Lateropulsion Scale is a five-item test used to measure lateropulsion, scored on a four to five point ordinal scale. It rates a participant's action/reaction of keeping or changing a position in sitting, standing, rolling in supine, transfers, and walking. A lower score is better. The minimum score is 0, indicating the absence of contraversive pushing behaviors. The maximum score is 17. Research indicates a score of ≥2 as a cutoff for the presence of contraversive pushing behaviors.
次要结局
- Change in Functional Independence Measure(Baseline, 3 weeks)
- Change in Passive Range of Motion(Baseline, 3 weeks.)
- Maximum Heart Rate(Week 1, Week 2, Week 3)
- Numerical Rating Pain Scale(Week 1, Week 2, Week 3)
- Change in Quality Indicators(Baseline, 3 weeks.)
- Change in Manual Muscle Test(Baseline, 3 weeks)
- Change in Berg Balance Scale(Baseline, 3 weeks)
- Change in Modified Ashworth Scale(Baseline, 3 weeks)
- Median Steps Per Session(Week 1, Week 2, Week 3)
- Change in 10 Meter Walk Test(Baseline, 3 weeks)
- Change in 6 Minute Walk Test(Baseline, 3 weeks)
- Change in Function in Sitting Test(Baseline, 3 weeks)
- Maximum Borg Rating of Perceived Exertion(Week 1, Week 2, Week 3)
研究者
Arun Jayaraman, PT, PhD
Research Scientist
Shirley Ryan AbilityLab