TetraplegiaNCT02969772
Reach and Palmar Grasp in Tetraplegics With Neuromuscular Electrical Stimulation: Assessment and Training.
A study testing Assessment of upper limb variables and Training protocol in people with Tetraplegia and Tetraparesis, run by Enio Walker Azevedo Cacho.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tetraplegia, Tetraparesis
- What is being tested?
- Assessment of upper limb variables and Training protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- tetraplegics (C4 to C7), complete or incomplete, traumatic lesion.
Who cannot join
- Neurological condition prior to spinal injury, orthopedic conditions in upper limb.
About this study
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.
Read the 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.
- Conditions
- Tetraplegia, Tetraparesis
- Being tested
- Assessment of upper limb variables, Training protocol
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of upper limb variablesOther
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 protocolOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Assessment of upper limb variables | Experimental | Assessment of clinical variables of tetraplegics reach-and-grasp pattern Receives: Other: Assessment of upper limb variables |
| Training protocol | Experimental | Training with electrical stimulation of upper limb Receives: Other: Training protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: change from baseline at twenty sessions - 5 weeks
Secondary outcomes (5)
ASIA
Classification of injury by American Spinal Injury Association
Measured: change from baseline at twenty sessions - 5 weeks
SCIM II
Spinal cord Independence measure
Measured: change from baseline at twenty sessions - 5 weeks
CUE
capabilities of upper extremity
Measured: change from baseline at twenty sessions - 5 weeks
FIM
Functional independence measure
Measured: change from baseline at twenty sessions - 5 weeks
Electromyography
Clavicular portion of pectoralis major, long head of biceps brachii, anterior and posterior deltoid, triceps and wrist extensors
Measured: change from baseline at twenty sessions - 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startDec 2005
- Primary completionDec 2006
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enio Walker Azevedo Cacho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor-investigator, Enio Walker Azevedo Cacho, University of Campinas, Brazil
- Investigators
- Alberto Cliquet Jr, PhD, Principal investigator, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969772
- Sponsor's protocol ID
- 06/58891-4
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reach and Palmar Grasp in Tetraplegics With Neuromuscular Electrical Stimulation: Assessment and Training.
- ClinicalTrials.gov ID
- NCT02969772
- Acronym / sponsor ID
- 06/58891-4
- Conditions
- Tetraplegia, Tetraparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Enio Walker Azevedo CachoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Dec 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assessment of upper limb variables | Experimental | Other: Assessment of upper limb variablesAssessment of clinical variables of tetraplegics reach-and-grasp pattern |
| Training protocol | Experimental | Other: Training protocolTraining with electrical stimulation of upper limb |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- tetraplegics (C4 to C7), complete or incomplete, traumatic lesion.
Key exclusion criteria (1 listed)
- Neurological condition prior to spinal injury, orthopedic conditions in upper limb.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of upper limb variablesInternational 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). | Other | Assessment of upper limb variables |
| Training protocolThe 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). | Other | Training protocol |
Primary outcome
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).
5 secondary outcomes
ASIA
Time frame: change from baseline at twenty sessions - 5 weeks
SCIM II
Time frame: change from baseline at twenty sessions - 5 weeks
CUE
Time frame: change from baseline at twenty sessions - 5 weeks
FIM
Time frame: change from baseline at twenty sessions - 5 weeks
Electromyography
Time frame: change from baseline at twenty sessions - 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Cliquet Jr, PhD principal investigator
University of Campinas
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of upper limb variables and Training protocol in people with Tetraplegia and Tetraparesis, run by Enio Walker Azevedo Cacho.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper limb Kinematics (time frame: change from baseline at twenty sessions - 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.