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临床试验/NCT04238013
NCT04238013终止不适用

Influence of Whole Body Vibration on Neuromodulation of Ankle Muscles in Persons With SCI

Shepherd Center, Atlanta GA1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年7月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1
试验地点
1
主要终点
Volitional Ankle Control-Tapping Task Performance

研究概览

简要总结

The ability to voluntarily move the ankles is important for walking. After spinal cord injury (SCI), this ability is impaired because of changes in the communication between the brain, spinal cord, and body. Whole body vibration (WBV) is a treatment that increases voluntary muscle control and decreases uncontrollable muscle movement in people with SCI. The purpose of this study is to understand how WBV can impact ankle control and uncontrollable muscle movement.

详细描述

Spinal cord injury can result in impaired walking ability and decreased independence in daily activities such as standing and transfers. The ability to voluntarily control the ankle muscles is an important component of walking that is impacted by changes in the corticospinal tract and the spinal reflex circuits. These changes have been associated with the inability to dorsiflex the ankle during swing phase (foot drop) and uncontrollable muscle spasms and stiffness in the ankle during terminal stance (spasticity), as well as during transfers. In order to improve functional outcomes and further develop rehabilitation techniques, the underlying contributions of the corticospinal tract and spinal reflex circuit to ankle control needs to be better understood. Non-invasive tools that target the corticospinal and spinal reflex circuit are being used in clinical settings in order to improve functional outcomes in persons with spinal cord injury. Whole body vibration (WBV) is a non-invasive tool that has been shown to increase voluntary motor output and decrease spasticity in persons with spinal cord injury. These improvements in function may be due to changes in the corticospinal tract and spinal reflex circuits. In order to determine the relative contributions of the corticospinal tract and spinal reflex circuits to increased voluntary ankle control and decreased spasticity, we will measure changes in the corticospinal tract and spinal reflex excitability before and after a single session of vibration. We will then determine which change (corticospinal or spinal) contributes more to increased voluntary ankle control and decreased spasticity. This information will help guide future research to further improve walking ability in persons with spinal cord injury.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Ability and willingness to consent and authorize use of Protected Health Information (PHI)
  • •Be between 18-85 years of age
  • •Be able to provide a letter of medical clearance for participation, if 70-85 years of age
  • •Have a SCI level of T12 of above, occurring more than 6 months ago
  • •Have a motor-incomplete severity classification (AIS C OR D)
  • •Have self-reported spasticity in at least one ankle
  • •Have a score of at least 2 indicating at least moderate spasticity on the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) clonus test in at least one ankle
  • •Have the ability to voluntarily move at least one ankle
  • •Must be able to stand and take at least 4 steps with or without assistive devices

排除标准

  • •Implanted metallic device in the head and/ or pacemaker
  • •Use of ankle-foot orthoses
  • •History of seizures
  • •History of frequent and/ or severe headaches
  • •Prior tendon or nerve transfer surgery
  • •Current pregnancy
  • •Inability or unwillingness to consent and Authorization for use of PHI
  • •Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord
  • •Neurologic level below spinal level T12
  • •History of cardiovascular irregularities
  • •Problems with following instructions
  • •Orthopedic problems that would limit participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees).
  • •Active infection of any type, as infection may exacerbate spasticity resulting in inability to identify the influence of the treatment

研究组 & 干预措施

Corticospinal Tract Excitability

Active Comparator

During the Corticospinal Tract Excitability arm, corticospinal excitability will be assessed by measuring motor evoked potentials after transcranial magnetic stimulation pre-post each intervention in conjunction with other outcome measures.

干预措施: Whole Body Vibration (WBV) (Other)

Corticospinal Tract Excitability

Active Comparator

During the Corticospinal Tract Excitability arm, corticospinal excitability will be assessed by measuring motor evoked potentials after transcranial magnetic stimulation pre-post each intervention in conjunction with other outcome measures.

干预措施: Electrical Stimulation (Other)

Spinal Reflex Circuit Excitability

Active Comparator

During the Spinal Reflex Circuit Excitability arm, spinal reflex circuit excitability will be assessed by measuring low frequency depression after Hoffmann-Reflex testing pre-post each intervention in conjunction with other outcome measures.

干预措施: Whole Body Vibration (WBV) (Other)

Spinal Reflex Circuit Excitability

Active Comparator

During the Spinal Reflex Circuit Excitability arm, spinal reflex circuit excitability will be assessed by measuring low frequency depression after Hoffmann-Reflex testing pre-post each intervention in conjunction with other outcome measures.

干预措施: Electrical Stimulation (Other)

结局指标

主要结局

Volitional Ankle Control-Tapping Task Performance

时间窗: Through study completion at 2 weeks

The participant will be seated with the foot positioned on a pressure sensitive switch embedded in a platform. Participants will be asked to voluntarily contract and relax the muscles that lift the front of the foot (while the heel stays in place on the platform) as quickly as possible for 10s for 4 trials with a 60s rest in between.

Ankle Spasticity-Ankle Clonus

时间窗: Through study completion at 2 weeks

This test measures the amount of spasticity in the ankle. Motion sensors to record the ankle joint angles will be used. For this test participants will sit upright. The leg will be raised and released allowing the front of the foot to land on the edge of a platform. The angle of the ankle and movement of the foot will be recorded as it drops and catches on the platform.

次要结局

  • Corticospinal tract excitability-Motor Evoked Potentials(Through study completion at 2 weeks)
  • Walking speed and walking pattern(Through study completion at 2 weeks)
  • Heart rate and %SpO2(Through study completion at 2 weeks)
  • Low frequency depression(Through study completion at 2 weeks)
  • Spinal Cord Assessment Tool for Spastic Reflexes(Through study completion at 2 weeks)
  • Ankle Isometric Strength Test(Through study completion at 2 weeks)

研究者

发起方
Shepherd Center, Atlanta GA
申办方类型
Other
责任方
Principal Investigator
主要研究者

Edelle Field-Fote, PT, PhD

Director, Spinal Injury Research & The Hulse Spinal Injury Laboratory

Shepherd Center, Atlanta GA

研究点 (1)

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