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临床试验/NCT01851629
NCT01851629已完成不适用

Adaptive Walking Responses Critical for Effective Community Ambulation Post-Incomplete Spinal Cord Injury

University of Florida4 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年6月1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
7
试验地点
4
主要终点
Changes in joint movement (Kinematics)

研究概览

简要总结

The purpose of this study is: (1) to establish assessment techniques (in our laboratory) to identify the functional integrity of long spinal tracts associated with adaptive walking recovery post-spinal cord injury and (2) to preliminary investigate locomotor outcomes associated with an adaptive locomotor training approach post-spinal cord injury.

详细描述

Eligible individuals without spinal cord injury that are enrolled in the study will participate for 1-2 days. These individuals may undergo a variety of non-invasive neurophysiological tests which evaluate spinal reflexes and integrity of specific spinal pathways. In addition, their movement may be assessed during walking on a treadmill and overground in a variety of different conditions (e.g. with mirrors, without mirrors, with obstacles, without obstacles).

Eligible individuals with spinal cord injury that are enrolled in the study will undergo the same testing as described above for the healthy controls. In addition, a small subset of these individuals may receive locomotor training (3 weeks of basic locomotor training followed by 3 weeks of adaptive locomotor training, separated by a 3 week washout period). For the individuals receiving locomotor training, they will be tested before and after each 3 week training session.

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
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
是

入选标准

  • •18 years or older
  • •no neurologic injury (for individuals without SCI)
  • •>12 mos post-incomplete SCI (iSCI), discharged from in- and out-patient rehabilitation, with diagnosis of first time motor iSCI (AIS C or D with upper motor neuron lesions at cervical or thoracic levels) (for individuals with SCI)
  • •medically stable condition with no changes in anti-spasticity meds
  • •ability to walk in the home and/or ambulate in the community using a single cane or crutch, bilateral canes or crutches, or no device
  • •walking speeds > 0.3 m/sec, with deficit performance on the Dynamic Gait Index
  • •medically approved for participation

排除标准

  • •current participation in another rehabilitation program/research protocol
  • •history of congenital SCI or other degenerative spinal disorders
  • •inappropriate or unsafe fit of the harness and/or joint contractures or severe spasticity that would prohibit the safe provision of training
  • •receipt of a therapeutic intervention or medication within the last 6 mos that would alter the nervous system's ability to respond to treatment (e.g. Botox injections)
  • •unable to safely receive transcranial magnetic stimulation due to positive history which prohibits its use

研究组 & 干预措施

ADAPT Locomotor Training

Experimental

Individuals receive 15 sessions of ADAPT-locomotor training for 3 weeks. During ADAPT-locomotor training, stepping in response to obstacles and walking challenges are practiced on a treadmill and overground.

干预措施: Locomotor Training (Behavioral)

Basic Locomotor Training

Active Comparator

Individuals will receive 15sessions of the traditional form of basic locomotor training for 3 weeks. Repetitive stepping patterns are practiced on the treadmill and overground.

干预措施: Locomotor Training (Behavioral)

Cross-Sectional Testing

Other

Individuals with and without spinal cord injury will be evaluated to develop protocols within our laboratory to assess reflexes (spinal tract integrity), walking ability, and whether mirror images during walking enhance or disrupt motor responses during walking.

干预措施: Cross-Sectional Testing (No Intervention) (Other)

结局指标

主要结局

Changes in joint movement (Kinematics)

时间窗: At approximately 0 weeks (pre-LT#1), 3 weeks (post-LT#1), 6 weeks (pre-LT#2) and 9 weeks (post-LT#2). Times may vary slightly if training sessions are missed (i.e. due to illness).

During walking on the treadmill and overground, movement of lower extremity joints (hip, knee, and ankle) will be quantified using reflective markers and a 3D motion analysis system.

次要结局

  • Changes in functional integrity of spinal pathways(At approximately 0 weeks (pre-LT#1), 3 weeks (post-LT#1), 6 weeks (pre-LT#2) and 9 weeks (post-LT#2). Times may vary slightly if training sessions are missed (i.e. due to illness).)
  • Changes in falls risks during adaptive walking challenges(At approximately 0 weeks (pre-LT#1), 3 weeks (post-LT#1), 6 weeks (pre-LT#2) and 9 weeks (post-LT#2). Times may vary slightly if training sessions are missed (i.e. due to illness).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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