跳至主要内容
临床试验/NCT01646216
NCT01646216已完成不适用

Long Term Split Belt Treadmill Training for Stroke Recovery

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2012年6月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length.

研究概览

简要总结

The purpose of this study is to determine whether split belt or conventional treadmill training can be used to treat walking pattern deficits from stroke and to determine whether this improves gait asymmetry and metabolic efficiency.

详细描述

Coordination between the legs during walking is often disrupted after neurological injury, resulting in asymmetric gait patterns. Recent data shows that walking patterns can be altered through treadmill training, even after central nervous system damage. The investigators have studied short-term adaptation of inter-limb coordination during walking using a split-belt treadmill to control speed of the two legs independently. Our findings demonstrate that walking patterns are adaptable. The investigators have also shown that people with cerebral damage from stroke can benefit in the short-term to correct asymmetric walking patterns. Since all of our previous work has focused on single training sessions or up to 4 week training sessions, the investigators would like to study long-term effects of split belt treadmill training. Therefore, the purpose of this study is to prepare for a clinical trial of split-belt treadmill training to treat walking pattern deficits from cerebral damage. The investigators will gather data to determine whether different types of treadmill training on a custom split-belt treadmill are likely to change/improve walking symmetry as well as metabolic efficiency.

The investigators will study adults with cerebral damage due to stroke. Subjects with hemiparesis will undergo training 3 times a week for a total of 33 training session. These 33 sessions will be broken into 3 blocks of 11 sessions. After each block of 11 sessions an evaluation will be done to record any gait improvements. Training for the subjects with hemiparesis will either be conventional treadmill walking (both legs moving at the same speed) or split-belt treadmill walking (with one leg moving faster than the other). These studies will provide important new information about normal mechanisms of locomotor adaptation, as well as providing a new rehabilitation tool for people with asymmetric gait patterns. Note that this study is not an aerobic conditioning program since subjects will work well below their age-adjusted target heart rate; it is instead a retraining program aimed at teaching people a new inter-limb coordination pattern as well as to determine whether this training can influence the subject's body's ability to use its intake of oxygen more efficiently. This study is also critical for developing procedural reliability processes, calculating effect sizes, training clinical staff, and determining other salient clinical variables in preparation for a randomized clinical trial.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • stroke or hemiparesis (>6 months post stroke)
  • able to walk but has residual gait deficit (including those who walk with a cane or walker)
  • This is their first and only stroke
  • Able to walk for 5 minutes at their self-paced speed
  • Adults age 20-80

排除标准

  • Cerebellar signs (e.g.ataxic hemiparesis)
  • Any neurologic condition other than stroke
  • Insulin dependent diabetes
  • Congestive heart failure
  • Peripheral artery disease with claudication
  • Pulmonary or renal failure
  • Unstable angina
  • Uncontrolled hypertension (>190/110 mmHg)
  • Severe aphasia
  • Orthopedic or pain conditions that limit walking
  • Total joint replacement in the lower extremities
  • Pregnancy

研究组 & 干预措施

Split-belt treadmill training

Experimental

Split-belt treadmill exercise

干预措施: Split belt treadmill (Behavioral)

结局指标

主要结局

Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length.

时间窗: After training (week 14), and 3 months after training

Subjects will either walk on a special mat that records their step lengths, or will wear special markers on the feet and body to record their step lengths.

次要结局

  • Change in Baseline Oxygen Intake(Post training (week 14), and 3 months follow up)
  • Walking Speed(Baseline, post training, and 3 month follow up.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy J. Bastian, Ph.D.

Dr. Amy J Bastian, Ph.D., PT

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

研究点 (2)

Loading locations...

相似试验

Long Term Split Belt Treadmill Training for Stroke... | 临床试验