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

NCT02969772 | Completed DMC

• 1 other identifier: 06/58891-4
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tetraplegia; Tetraparesis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• ASIA

  change from baseline at twenty sessions - 5 weeks

• SCIM II

  change from baseline at twenty sessions - 5 weeks

• CUE

  change from baseline at twenty sessions - 5 weeks

• FIM

  change from baseline at twenty sessions - 5 weeks

• Electromyography

  change from baseline at twenty sessions - 5 weeks

Other Outcomes (1)

• demographic dates

  baseline

Study Arms (2)

Assessment of upper limb variables

EXPERIMENTAL

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

Other: Assessment of upper limb variables

Training protocol

EXPERIMENTAL

Training with electrical stimulation of upper limb

Other: Training protocol

Interventions

Assessment of upper limb variables OTHER

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).

Assessment of upper limb variables

Training protocol OTHER

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).

Training protocol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Enio Walker Azevedo Cacho: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alberto Cliquet Jr, PhD

  University of Campinas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 21, 2016
• Study Start: December 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2010
• Last Updated: November 21, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share