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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02969772
Other study ID # 06/58891-4
Secondary ID
Status Completed
Phase N/A
First received November 14, 2016
Last updated November 16, 2016
Start date December 2005
Est. completion date December 2010

Study information

Verified date November 2016
Source University of Campinas, Brazil
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Assessment of upper limb variables
International Standards for Neurological and Functional Classification of Spinal Cord Injuries of American Spinal Injury Association (ASIA); Functional Independence Measure (FIM); The following kinematic variables of arm were studied: 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); Capabilities of Upper Extremity instrument (CUE); Spinal cord independence measure (SCIM II); electromyography (Clavicular portion of pectoralis major, long head of biceps brachii, anterior and posterior deltoid, triceps and wrist extensors).
Training protocol
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).

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Enio Walker Azevedo Cacho Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type Measure Description Time frame Safety issue
Other demographic dates name, address, time since lesion, other injuries. baseline Yes
Primary Upper limb Kinematics 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). change from baseline at twenty sessions - 5 weeks Yes
Secondary ASIA Classification of injury by American Spinal Injury Association change from baseline at twenty sessions - 5 weeks Yes
Secondary SCIM II Spinal cord Independence measure change from baseline at twenty sessions - 5 weeks Yes
Secondary CUE capabilities of upper extremity change from baseline at twenty sessions - 5 weeks Yes
Secondary FIM Functional independence measure change from baseline at twenty sessions - 5 weeks Yes
Secondary Electromyography Clavicular portion of pectoralis major, long head of biceps brachii, anterior and posterior deltoid, triceps and wrist extensors change from baseline at twenty sessions - 5 weeks Yes
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