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临床试验/NCT03548090
NCT03548090已完成不适用

The Effects of Plantar Flexion Training on Plantar Flexion Activation, Torque, and Step Length Asymmetry in People With Chronic Stroke

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Plantar flexion torque as assessed by isokinetic dynamometry

研究概览

简要总结

This study consists of three phases that aim to develop an exercise intervention to promote maximal activation of ankle plantar flexors in the paretic lower extrimty (LE) in order to restore a more normalized gait pattern in chronic stroke survivors.

The aim of the first phase is to determine if there are differences between standing on different levels of inclination on plantar flexion activation during forward movement of the contralateral LE in adults with chronic with stroke.

The aim of second phase is to determine if there are differences between different percentages of weight bearing on the paretic LE on plantar flexion activation during forward movement of the contralateral LE in adults with chronic stroke.

The aim of the third phase is to determine if there are differences between a 4-week plantar flexion training intervention and conventional physical therapy.

详细描述

Description of Arms:

This study has three phases. The first phase is performed in a cross-over fashion. Participants will stand on two different incline angles on the paretic LE and simultaneously move a small skateboard forward with the non-paretic LE. The testing order for the two different incline angles will be randomized, and all participants will be required to complete both incline angle conditions within a single test session.

The second phase will also be performed in a cross-over fashion. Participants will stand with three different percentages of body weight on their paretic LE while moving the skateboard forward with the non-paretic LE. The testing order for the three body weight percentages will be randomized. All participants will be required to complete all three body weight conditions within a single test session.

In the third phase, participants will be randomized to either a control 4-week exercise intervention (conventional physical therapy) or a 4-week experimental exercise intervention (plantar flexion training). Both the control and exerimental arms will complete over-ground multi-directional gait training and home exercise.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be able to perform five times sit to stand test without the use of upper extremities
  • Must have 10 degrees of passive ankle dorsiflexion measured in standing
  • Must be able to walk with supervision level assistance with no assistive device

排除标准

  • Currently receiving physical therapy
  • History of orthopedic ankle instability
  • Lacking knee extension to neutral
  • Unable to understand English
  • Unable to follow multi-step commands
  • History of orthopedic pathology that prevents completion of experimental condition
  • Pain with weight bearing on paretic LE
  • Received Botox to the plantar flexors within the last three months or phenol injections within the last six months
  • Walk with a longer nonparetic step length than paretic step length

结局指标

主要结局

Plantar flexion torque as assessed by isokinetic dynamometry

时间窗: baseline, 6 weeks (relative to the phase 3 intervention)

Peak plantar flexion torque will be acquired using an isokinetic dynamometer(Biodex Medical Systems, Shirely, New York, USA). Calibration of the Biodex® will be performed prior to the assessment of each individual. For each participant, the plantar flexors will be warmed-up on a LE ergometer for 10 minutes prior to testing. The participant will be fully secured to prevent compensatory behaviors from trunk or hips that may influence results. A pre-speed warm up on the Biodex of three submaximal repetitions and one maximal repetition will be conducted prior to testing so the participant understands what these repetitions feel like. The angular velocity will be set a 60°/second, five repetitions will be performed, and the peak torque of the plantar flexors will be collected.

Muscle activity of the medial gastrocnemius as assessed by surface EMG

时间窗: on the 1 day of the phase 2 intervention

Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).

Muscle activity of the soleus as assessed by surface EMG

时间窗: on the 1 day of the phase 2 intervention

Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).

Step length asymmetry ratio as assessed by the GAITRite®

时间窗: baseline, 6 weeks (relative to the phase 3 intervention)

The step length asymmetry ratio will be calculated by dividing the paretic step length by non-paretic step lengths. The magnitude of the ratio indicates the nature of the asymmetry, with symmetrical gait defined as step length ratio of 0.9-1.1, and asymmetrical gait where the non-paretic step lengths are longer than the paretic step lengths with any step length ratio greater than 1.1.

次要结局

  • Gait speed as assessed by the GAITRite®(baseline, 6 weeks (relative to the phase 3 intervention))
  • Muscle activity of the medial gastrocnemius as assessed by surface EMG(baseline, 6 weeks (relative to the phase 3 intervention))
  • Muscle activity of the soleus as assessed by surface EMG(baseline, 6 weeks (relative to the phase 3 intervention))
  • Quality of life as assessed by the Stroke Impact Scale(baseline, 6 weeks (relative to the phase 3 intervention))

研究者

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

Daniel Wingard

Physical therapist

The University of Texas Health Science Center, Houston

研究点 (2)

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