跳至主要内容
临床试验/NCT02969772
NCT02969772已完成不适用

Reach and Palmar Grasp in Tetraplegics With Neuromuscular Electrical Stimulation: Assessment and Training.

Enio Walker Azevedo Cacho0 个研究点目标入组 23 人开始时间: 2005年12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
发起方
入组人数
23
主要终点
Upper limb Kinematics

研究概览

简要总结

The aim of the study was to evaluate the tetraplegics movement strategies, assisted by Neuromuscular Electrical Stimulation (NMES), on the reach and palmar (RP) grasp to different weights objects.Tetraplegics had their RP grasp movement captured by four infrared cameras and 6-reflexive markers attached on the trunk and right arm, assisted or not by NMES, in the triceps, extensor carpi radialis longus, extensor digitorum communis, flexor digitorum superficialis, opponens pollicis and lumbricalis muscles. The grasp was made in three cylindrical objects (different diameters and weights) placed in trunk midline in an equivalent distance of the arm's length. The patients were able to reach and made palmar grasp in all cylinders using the stimulation sequences assisted by NMES.

详细描述

Prior to the kinematic captures, all patients selected in the study received 20 sessions of NMES therapy, twice a week, with 10 weeks of duration. The strengthening sessions plus training prior to the kinematic study of movement strategies has the objective to condition the paretic muscles to the functional activity.

Twenty sessions was divided in 10 sessions of strengthening and 10 sessions of the functional training of reaching and grasping assisted with electrical stimulation.

The strengthening sessions consisted of 20 minutes of electrical stimulation on triceps, extensor carpi radialis longus, extensor digitorum communis, lumbricalis, flexor digitorum superficialis and opponens pollicis muscles.

The functional training sessions was performed through movements the reach and palmar grasp with NMES of the several cylindrical and conical objects of different weights (30 minutes sessions). The NMES was used to facilitate movements of reach (triceps muscle), opening (extensor carpi radialis longus and extensor digitorum communis muscle), positioning (extensor carpi radialis longus, flexor digitorum superficialis and lumbricalis muscle), palmar grasp (extensor carpi radialis longus, flexor digitorum superficialis, opponens pollicis muscle) and releasing (extensor carpi radialis longus and extensor digitorum communis muscle). Since the temporal organization varied among tetraplegics, some of them required more time to some stages of the sequence.

For NMES, the eight-channel stimulator, controlled by a microcomputer was used with pulse frequency, 25 Hz; pulse duration, 300 milliseconds; on/off duration 2/2sec; maximum pulse width fixed at 250 microampere, and the amplitude individually adjusted to achieve the excitability threshold for each muscle. The amplitude was adjusted throughout the training, in order to produce the desired muscle contraction. This parameters was used in all of therapies and in the kinematic assessment. The stimulation was applied with self-adhesive surface electrodes taped to the skin.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •tetraplegics (C4 to C7), complete or incomplete, traumatic lesion.

排除标准

  • •Neurological condition prior to spinal injury, orthopedic conditions in upper limb.

研究组 & 干预措施

Assessment of upper limb variables

Experimental

Assessment of clinical variables of tetraplegics reach-and-grasp pattern

干预措施: Assessment of upper limb variables (Other)

Training protocol

Experimental

Training with electrical stimulation of upper limb

干预措施: Training protocol (Other)

结局指标

主要结局

Upper limb Kinematics

时间窗: change from baseline at twenty sessions - 5 weeks

shoulder, elbow and wrist angles; percentage of time to peak velocity; movement time; peak velocity and movement smoothness (number of velocity peaks and index of curvature).

次要结局

  • FIM(change from baseline at twenty sessions - 5 weeks)
  • CUE(change from baseline at twenty sessions - 5 weeks)
  • SCIM II(change from baseline at twenty sessions - 5 weeks)
  • ASIA(change from baseline at twenty sessions - 5 weeks)
  • Electromyography(change from baseline at twenty sessions - 5 weeks)

研究者

发起方
Enio Walker Azevedo Cacho
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Enio Walker Azevedo Cacho

PhD

University of Campinas, Brazil

相似试验