Functional and Physiological Responses to Lokomat Therapy (Pilot Study)
研究概览
详细说明
Description of the Clinical Lokomat Therapy program:
This is a 12-week program with 3 to 5 sessions per week. Each session includes: 15-20 minutes of patient set-up (set-up time becomes about 5 to 10 minutes after a few sessions), 5-10 minutes of warm-up, 20-40 minutes of Lokomat therapy, 5-10 minutes of cool-down, and 5-10 minutes to remove the patient from the system. During the Lokomat sessions, heart rate and blood pressure are monitored by the therapist and recorded. Work performed is measured and recorded in the Lokomat computer for time, speed, amount of weight bearing, and distance.
Description of the Research Component:
A pre and post, prospective study design will be employed. Baseline measurements (Please see below and Table 1 for detailed descriptions) will be performed prior to start of the Lokomat therapy program and then again after completion of the 12-week program. A chart review will be performed at baseline only for documentation of medical history and medications. In a subset of patients a muscle biopsy will be performed for gene expression at baseline and week 12.
As part of Clinical Care, during each of the Lokomat therapy sessions the following information is collected:
- Work (total time, speed, distance, amount of weight bearing)
- Heart rate (HR)
- Blood Pressure (SBP, DBP)
- Perception of exertion (Borg Scale)
- Lipid profile (pre and post)
- Albumin (pre and post)
For Research purposes the following is being proposed:
Review and record work, HR, BP, Borg Scale from all clinical sessions
Baseline and Week 12 measurements (performed on a separate days or prior to the sessions):
- Resting energy expenditure (REE)
- Body Composition [dual energy x-ray absorptiometry (DEXA) ) - [scans include total body, dual femur, and the knee], partial body potassium counting (PBKleg), bioelectrical impedance analysis (BIA), anthropometric and skin fold measurements]
- Fasting blood draw for plasma glucose and insulin (FPG, FPI), lipid profile, testosterone, sex hormone binding globulin (SHBG), insulin-like growth factor 1 (IGF-1), bone markers, coagulation factors, platelet aggregation, 2 hour standard oral glucose tolerance testing (OGTT) with insulin levels.
- Autonomic and blood pressure regulation studies [resting and tilt table provocation, for heart rate and blood pressure variability (HRV, BPV), arterial blood flow, and venous occlusion]
- Disability-specific quality of life (QOL) and activities of daily living surveys [GI-Bowel survey, brief pain inventory (BPI), fatigue survey, spasticity scale, mini mental status exam (MMSE)]. These disease-specific QOLs will include the question "How do you rate your general health and well-being over the past week?" A Lickert scale response will be incorporated.
- Functional Mobility Assessment
- Muscle biopsy for gene expression (subset of patients only).
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
New York
-
Bronx、New York、美国、10468
- VA Medical Center, Bronx
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
The inclusion criteria are based on the guidelines set by the clinical Lokomat therapy program.
- Patients will have been evaluated on the Rehabilitation Service for entry into the clinical therapy program.
- Any patient who is already eligible for Lokomat therapy is a candidate for this research project.
Exclusion Criteria:
- Pregnant women
- History of fractures of the lower extremities
- Bone density study indicating bone loss greater than 5 standard deviations from normal.
- Fixed contractures of the ankles, knees or hips
- Uncontrolled spasticity that significantly interferes with movement of lower extremities.
- Uncooperative, unmotivated patients or patients whom cannot follow instructions on a consistent basis or communicate effectively with the treating clinicians.
- Pressure ulcers over the greater trochanters, ischial tuberosities and sacrum.
- Weight greater than 250 lbs
- severe orthostatic hypotension (drop in blood pressure more than 30mm Hg when moving from sitting to standing posture)
- Acute medical illness (i.e. infection)
- Recently documented DVT in lower extremities
- SCI ASIA's A and B
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
---|
第 1 组
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
This pilot study for power calculations on future studies that will characterize the potential benefits of Lokomat rehabilitation training on cardiovascular function, body composition and endocrine/metabolic function
大体时间:After completion of 24 clinical Lokomat rehabilitation sessions
|
After completion of 24 clinical Lokomat rehabilitation sessions
|
合作者和调查者
调查人员
- 首席研究员:Ann M. Spungen, EdD、VA Medical Center, Bronx
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- B4162C-11
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.