Investigating Effects of High-intensity Gait Training on Gait Function, Balance and Depression Following Stroke and the Impact of Social Determinants of Health and Depression on Patients' Adherence to Physical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- 6-minute walk test
研究概览
简要总结
The purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. The investigators want to know about improvements in participants' walking function and mental health after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions.
详细描述
The purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. The investigators want to know about improvement in participants' walking function and mental health after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions.
The findings from this study will help the researchers and clinicians decide how to help people with stroke better. Further, the findings will determine how depressive symptoms, health literacy, and other factors such as language and education affect attendance to therapy.
About 24 subjects will take part in this research.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •English or Spanish speaking
- •A diagnosis of stroke (intracerebral hemorrhage or acute ischemic stroke)
- •Referred to LVHN Outpatient Neurologic Rehab (hereafter referred to as outpatient PT)
排除标准
- •Unable to follow 1-step commands
- •> 220 pounds (100 kg)
- •Height < 5'0" or > 6'4"
- •Unable to take a few steps with assistance
- •A score of ≥ 50/56 on Berg Balance Scale (BBS)
- •A score of ≥ 26/30 on Functional Gait Assessment (FGA)
- •Resting blood pressure >180/110 mmHg
- •Resting heart rate > 120 bpm
- •Severe cardiac disease (New York Heart Association Classification IV)
- •Severe spasticity (Modified Ashworth score > 3)
- •Unstable spine or unhealed pelvic/limb fractures
- •Active heterotrophic ossification impacting lower extremity range of motion
- •Significant lower or upper extremity contractures
- •Inability to achieve neutral ankle dorsiflexion with 12° of knee flexion
- •Pregnancy
- •Colostomy
- •Poor skin integrity
- •Unresolved deep vein thrombosis
- •Lower limb prosthesis or amputation
- •Leg length discrepancies > 0.5 inches for upper legs, 0.75 inches for lower legs
- •ROM restrictions preventing normal, reciprocal gait
- •Inability to stand for > 3 minutes due to pain or orthostatic hypotension
- •Pusher syndrome
- •Cortical blindness
结局指标
主要结局
6-minute walk test
时间窗: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Measures aerobic capacity and endurance
Berg Balance Scale
时间窗: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
a 14-item objective measure that assesses static balance and fall risk in adults. Berg balance scale scoring ranges from 0 to 56, with higher scores mean a better outcome.
Multidimensional Scale of Perceived Social Support (MSPSS)
时间窗: Pre-intervention (baseline)
The MSPSS is a 12-item self-administered scale that measures social support. It contains 12-items, rated on a 7-point Likert-type scale, ranging from 1 "very strongly disagree" to 7 "very strongly agree." The scale was divided into 3 subscales: family, friends, and significant other, with each section consisting of 4 items. The response scale ranges from 12 to 84. Higher scores indicate a greater family social support.
10-meter walk test
时间窗: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Measures forward gait velocity
Functional Gait Assessment
时间窗: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
This scale assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. Scoring for each FGA item ranges from 0 for severe impairment to 3 for normal performance. The highest score possible is 30, with higher scores correlating better gait function.
Rate of patient attendance (Compliance) to physical therapy
时间窗: Participant's attendance to physical therapy is tracked throughout the intervention sessions.
Greater than or equal to 80% attendance to physical therapy is considered compliance to physical therapy.
3-meter backwards walk test
时间窗: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Measures backward gait velocity
Surface electromyography (EMG)
时间窗: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Electromyographical recording of 8 leg muscles () is done during forward and backward walking tests.The EMG will be recorded during 3-meter Backward Walk Test, 6-minute Walk Test, and 10-meter Walk Test in all participants
Borg Rating Scale of Perceived Exertion (RPE)
时间窗: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
RPE is used to prescribe and monitor exercise intensity and correlates well with physiological measures of exercise intensity, including heart rate. The Borg Rating Scale of Perceived Exertion will be measured in all participants at the completion of 6 Minute Walk test. It ranges from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion." A lower score indicates a better exercise endurance.
Patient Health Questionnaire (PHQ-9)
时间窗: Pre-, mid- (week 5) and post-intervention (within 2 weeks after the conclusion of intervention)
Depressive symptom questionnaire. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). A lower score indicates less depressive symptoms.
Newest Vital Sign
时间窗: Pre-intervention (baseline)
The NVS is a 6-question screening tool that identifies participants' risk of low or limited health literacy based on interpreting an ice cream nutrition label. It is available from Pfizer Pharmaceutical Company. The level of health literacy for each individual will be categorized based on the scores: a score of 0-1 suggests a high likelihood of limited literacy, a score of 2-3 indicates the possibility of limited literacy, and a score of 4-6 almost always indicates adequate literacy. This categorical variable will be used to determine the association with adherence to physical therapy.
次要结局
未报告次要终点
研究者
Soo Yeon Sun, PT, PhD
Associate Professor
Alvernia University