Reach and Palmar Grasp in Tetraplegics With Neuromuscular Electrical Stimulation: Assessment and Training.
Primary Purpose
Tetraplegia, Tetraparesis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Assessment of upper limb variables
Training protocol
Sponsored by
About this trial
This is an interventional treatment trial for Tetraplegia
Eligibility Criteria
Inclusion Criteria:
- tetraplegics (C4 to C7), complete or incomplete, traumatic lesion.
Exclusion Criteria:
- Neurological condition prior to spinal injury, orthopedic conditions in upper limb.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Assessment of upper limb variables
Training protocol
Arm Description
Assessment of clinical variables of tetraplegics reach-and-grasp pattern
Training with electrical stimulation of upper limb
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
ASIA
Classification of injury by American Spinal Injury Association
SCIM II
Spinal cord Independence measure
CUE
capabilities of upper extremity
FIM
Functional independence measure
Electromyography
Clavicular portion of pectoralis major, long head of biceps brachii, anterior and posterior deltoid, triceps and wrist extensors
Full Information
NCT ID
NCT02969772
First Posted
November 14, 2016
Last Updated
November 16, 2016
Sponsor
Enio Walker Azevedo Cacho
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02969772
Brief Title
Reach and Palmar Grasp in Tetraplegics With Neuromuscular Electrical Stimulation: Assessment and Training.
Official Title
Reach and Palmar Grasp in Tetraplegics With Neuromuscular Electrical Stimulation: Assessment and Training.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Enio Walker Azevedo Cacho
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
For kinematic captures, the participants performed reach and grasp with the dominant arm (right), assisted and not assisted by NMES. The subjects had no restriction for trunk anterior shifting but for safety reasons were kept seating upright in their own daily use wheelchair (the one they were more adapted to) and the non-dominant arm (left) was left resting over the abdomen in an attempt to minimize the influence of the non evaluated member on postural control.
For the initial position, the dominant arm was held at the side of the trunk, with the elbow flexed at 90º and the forearm in neutral position on the table. Tetraplegic subjects were seated in front of a task-table with the cylinder on it. They were instructed to reach and grasp three different cylinders (object A :200g weight, 115 mm height, 40 mm diameter; object B: 270g, 115 mm e 50 mm; and object C: 480g, 115 mm e 60 mm), one at a time and bring it to the initial hand position.
The analysis of kinematic data was performed from the beginning of the movement (starting position), until the early return of hand position (with or without the cylinder). The cylinder was positioned in front of the subject sternum, with a distance equal to the arm's length (from the medial border of axilla to the distal wrist crease).
The subjects were asked to perform five repetitions of each task for all three cylinders, in a total of 15 repetitions assisted and 15 not assisted by NMES. Once the experiment started, the subject could not touch the table with the forearm, until the task was finished. The command used to start the experiment was "GO", and they were instructed to perform the movement naturally and not to worry about the velocity and time of duration. Patients were evaluated in the two situations (with and without NMES) with stimulation electrodes placed in the skin surface and the cables connected to the stimulator.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetraplegia, Tetraparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Assessment of upper limb variables
Arm Type
Experimental
Arm Description
Assessment of clinical variables of tetraplegics reach-and-grasp pattern
Arm Title
Training protocol
Arm Type
Experimental
Arm Description
Training with electrical stimulation of upper limb
Intervention Type
Other
Intervention Name(s)
Assessment of upper limb variables
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Training protocol
Intervention Description
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).
Primary Outcome Measure Information:
Title
Upper limb Kinematics
Description
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).
Time Frame
change from baseline at twenty sessions - 5 weeks
Secondary Outcome Measure Information:
Title
ASIA
Description
Classification of injury by American Spinal Injury Association
Time Frame
change from baseline at twenty sessions - 5 weeks
Title
SCIM II
Description
Spinal cord Independence measure
Time Frame
change from baseline at twenty sessions - 5 weeks
Title
CUE
Description
capabilities of upper extremity
Time Frame
change from baseline at twenty sessions - 5 weeks
Title
FIM
Description
Functional independence measure
Time Frame
change from baseline at twenty sessions - 5 weeks
Title
Electromyography
Description
Clavicular portion of pectoralis major, long head of biceps brachii, anterior and posterior deltoid, triceps and wrist extensors
Time Frame
change from baseline at twenty sessions - 5 weeks
Other Pre-specified Outcome Measures:
Title
demographic dates
Description
name, address, time since lesion, other injuries.
Time Frame
baseline
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
tetraplegics (C4 to C7), complete or incomplete, traumatic lesion.
Exclusion Criteria:
Neurological condition prior to spinal injury, orthopedic conditions in upper limb.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Cliquet Jr, PhD
Organizational Affiliation
University of Campinas
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Reach and Palmar Grasp in Tetraplegics With Neuromuscular Electrical Stimulation: Assessment and Training.
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