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Clinical Trials/NCT02969772
NCT02969772CompletedNot Applicable

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

Enio Walker Azevedo Cacho0 sites23 target enrollmentStarted: December 1, 2005Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
23
Primary Endpoint
Upper limb Kinematics

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Assessment of upper limb variables

Experimental

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

Intervention: Assessment of upper limb variables (Other)

Training protocol

Experimental

Training with electrical stimulation of upper limb

Intervention: Training protocol (Other)

Outcomes

Primary Outcomes

Upper limb Kinematics

Time Frame: 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).

Secondary Outcomes

  • 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)

Investigators

Sponsor
Enio Walker Azevedo Cacho
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Enio Walker Azevedo Cacho

PhD

University of Campinas, Brazil

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