StrokeNCT02390115
Effects of Elastic Tape in Shoulder Movements in Hemiparetic Subjects
A study testing Elastic tape application in shoulder in people with Stroke, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The stroke is the second cause of death and the first of disabilities in the world. Although a motor spontaneous recovery is observed, around 50 to 70% of the hemiparetic upper extremity present alterations of upper extremity, limiting the performance of daily activities even after 2 to 4 years of strokes. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Elastic tape application in shoulder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Jul 2018
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 40 and 70 years and present a minimum score on the Mini Mental State Examination, according to the subject's educational level.
- All subjects must have normal vision or corrected to normal.
- The hemiparetic subjects must present a level of less than 3 spasticity on the Modified Ashworth Scale for shoulder abductor and flexor muscles
- Ability to voluntarily perform the range of motion
- Proper trunk control confirmed by the ability to remain in the seated position without support to the trunk and/or of the arms for 1 minute.
Who cannot join
- diabetes mellitus
- ulcers or skin lesions
- adverse reactions to tape (redness and itching)
- severe cardiovascular or peripheral vascular diseases (heart failure, arrhythmias, angina pectoris, and acute myocardial infarction)
- other neurological or orthopedic diseases
- cognitive impairments
Show all 20Show fewer
- presence of sensorimotor peripheral neuropathy
- any history of joint or muscle injuries of the shoulder complex or cervical joints (fractures or surgery)
- shoulder pain during the tests
- presence of any history of joint or muscular injuries of the shoulder complex or cervical joints (fractures or surgery)
- body mass index (BMI) greater than 28 kg/m²
- alterations of sensitivity
- understanding of aphasia
- apraxia
- hemineglect and/or plegia.
- Individuals with other neurologic diseases
- Acute stroke
- Hemorrhagic stroke or any injury to the occipital lobe
- Brainstem or cerebellum injury
- Range of motion of less than 90° flexion or 30° extension and adduction of the shoulder will be excluded.This range of motion is required to standardize the placing of the elastic tape.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de São Carlos
São Carlos, São Paulo, 13565-905
About this study
Official title: Effects of Elastic Tape in Proprioception and Performance of Shoulder Movements in Chronic Hemiparetic Subjects
The stroke is the second cause of death and the first of disabilities in the world. Although a motor spontaneous recovery is observed, around 50 to 70% of the hemiparetic upper extremity present alterations of upper extremity, limiting the performance of daily activities even after 2 to 4 years of strokes. More recently used in neurological rehabilitation, the ability to promote sensory-motor facilitation is given to the Elastic Tape (ET). However, its safety and efficacy in the treatment of post-stroke individuals still require further investigation. Thus, the objective of this project is to evaluate the immediate effects of ET, applied to the paretic shoulder on proprioception during movements of abduction and flexion of the shoulder and muscle activation and kinematic variables for the reaching in chronic hemiparetic. Fifteen subjects with chronic hemiparesis will participate these crossover sham-controlled trial. Participants will be randomized into two condition: elastic tape (ET) followed by sham tape (ST- strapping) or ST followed by ET. One month of washout period was considered. The motor impairment and the dominance before stroke will be evaluated by Fugl-Meyer scale and the Inventory Side dominance of Edinburgh, respectively. ET will apply deltoid (anterior, middle and posterior). Assessment before and after the application of ET will be performed. For proprioception assessment (joint position sense) will be evaluated using a dynamometer. Absolute error for shoulder abduction and flexion at the 30° and 60° was calculated. For the assessment of motor performance in a functional task (reach a glass of water), spatio-temporal parameters (total duration of the motion, peak velocity, time to peak velocity) and three-dimensional joint kinematics of the trunk, scapula, shoulder, and elbow (total range of motion, joint angle maximum and minimum) will be used. Concomitantly, bilateral activation of the deltoid (anterior, middle and posterior), trapezius (upper and lower), serratus anterior and pectoral major will be assessed by electromyography during reach. The following electromyographic variables will be analyzed: activation amplitude, muscle onset and maximum and minimum activation. For statistical analysis, the normality and homogeneity tests will be applied. If the variables have a distribution considered normal and homogeneous, Two-way ANOVA with repeated measures gift will be applied. Otherwise it will be applied to non-parametric statistics Friedman. Will be considered a 0.05 significance level for all statistical tests.
- Conditions
- Stroke
- Being tested
- Elastic tape application in shoulder
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic tape application in shoulderOther
| Study group | Role | What they receive |
|---|---|---|
| Elastic Tape | Active comparator | Tape placing will consider as the initial anchor the acromioclavicular joint, and as the final one the point immediately below the insertion of the deltoid muscle. Two centimeters anchor will be considered for all the participants, and the active zone will be equivalent to the distance between two anchors. The first tape will be placed to the anterior portion of the deltoid with the shoulder at 30° passive extension. The second tape will be placed to the middle portion of the deltoid with the shoulder at 30° of passive horizontal adduction. For placing the third tape to the posterior deltoid, the limb will be positioned at 90° of passive flexion of the shoulder. The elastic tape tension will be placed as previously described as "paper tension" and it is equivalent to 10-15% of the total elastic tape tension. Receives: Other: Elastic tape application in shoulder |
| Sham | Sham comparator | The sham elastic tape will be placed using the same tape to the paretic shoulder. However, the rigid tape will be placed without tension with the upper limb supporting at 90 degree elbow flexion, 0 degrees abduction and adduction of the shoulder. Receives: Other: Elastic tape application in shoulder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in joint sense position (proprioception) at 10 minutes
This analysis will be performed on a dynamometer with the participant seated and blindfolded. Initially, the dynamometer will move the arm participant in references angles. Each subject will be allowed to sense the reference angle for 10 seconds before the upper extremity is returned passively to the start position. Subsequently, the upper extremity will be moved passively by the dynamometer toward the reference position, and subjects will press a button in their hand that will stop the machine when they feel the position has been reached. The absolute error (in degrees) will be calculated as the difference between the indicated and reference positions.
Measured: baseline and 10 minutes post-application of placebo ou elastic tape
Change from Baseline in joint kinematics of reach at 10 minutes
The Qualisys system will be used for this evaluation. Passive reflective markers will be placed on the anatomical landmarks (anatomical markers) according to the International Society of Biomechanics. In addition, clusters will be placed on the sternum, scapula (most superficial part of the acromion), arm (positioned below the insertion of the deltoid muscle), and forearm (5 cm below the cubital fossa). After positioning the markers and clusters, the collection of static posture (duration 5 seconds) will be performed. In static posture, the individuals should be seated in an adjustable chair. Then, the subject will perform the reaching movement to touch a glass placed at 80% of the length of the upper limb and return to the starting position (pronated hands on the thigh). The variables are calculated: duration of movement (second), speed (mm/s), displacement of the joints of the trunk, scapula, shoulder and elbow (°).
Measured: baseline and 10 minutes post-application of placebo ou elastic tape
Change from Baseline in Electromyography during the reach at 10 minutes
The collection of electromyographic activity will be performed only during the kinematics of the reaching movement. The electrodes are positioned parallel to the orientation of muscle fibers in the anterior, middle, and posterior deltoid, pectoral major, upper and inferior trapezius, and serratus anterior. Initially, five seconds in the rest position and 10 seconds of EMG activity before the start of the reaching movement will be collected. The following variables will be calculated: activation amplitude, maximum and minimum activation coefficient variation, onset e offset.
Measured: baseline and 10 minutes post-application of placebo ou elastic tape
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2016
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Lopes dos Santos, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390115
- Sponsor's protocol ID
- 966.636
- Status last verified
- May 2019
- First submitted
- 2 Mar 2015
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Jaspers E, Desloovere K, Bruyninckx H, Klingels K, Molenaers G, Aertbelien E, Van Gestel L, Feys H. Three-dimensional upper limb movement characteristics in children with hemiplegic cerebral palsy and typically developing children. Res Dev Disabil. 2011 Nov-Dec;32(6):2283-94. doi: 10.1016/j.ridd.2011.07.038. Epub 2011 Sep 8.
PubMed 21862283Niessen MH, Veeger DH, Koppe PA, Konijnenbelt MH, van Dieen J, Janssen TW. Proprioception of the shoulder after stroke. Arch Phys Med Rehabil. 2008 Feb;89(2):333-8. doi: 10.1016/j.apmr.2007.08.157.
PubMed 18226659Carda S, Invernizzi M, Baricich A, Cisari C. Casting, taping or stretching after botulinum toxin type A for spastic equinus foot: a single-blind randomized trial on adult stroke patients. Clin Rehabil. 2011 Dec;25(12):1119-27. doi: 10.1177/0269215511405080. Epub 2011 Jul 5.
PubMed 21729974
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Elastic Tape in Proprioception and Performance of Shoulder Movements in Chronic Hemiparetic Subjects
- ClinicalTrials.gov ID
- NCT02390115
- Acronym / sponsor ID
- 966.636
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 17 Mar 2015 (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 stroke is the second cause of death and the first of disabilities in the world. Although a motor spontaneous recovery is observed, around 50 to 70% of the hemiparetic upper extremity present alterations of upper extremity, limiting the performance of daily activities even after 2 to 4 years of strokes. More recently used in neurological rehabilitation, the ability to promote sensory-motor facilitation is given to the Elastic Tape (ET). However, its safety and efficacy in the treatment of post-stroke individuals still require further investigation. Thus, the objective of this project is to evaluate the immediate effects of ET, applied to the paretic shoulder on proprioception during movements of abduction and flexion of the shoulder and muscle activation and kinematic variables for the reaching in chronic hemiparetic. Fifteen subjects with chronic hemiparesis will participate these crossover sham-controlled trial. Participants will be randomized into two condition: elastic tape (ET) followed by sham tape (ST- strapping) or ST followed by ET. One month of washout period was considered. The motor impairment and the dominance before stroke will be evaluated by Fugl-Meyer scale and the Inventory Side dominance of Edinburgh, respectively. ET will apply deltoid (anterior, middle and posterior). Assessment before and after the application of ET will be performed. For proprioception assessment (joint position sense) will be evaluated using a dynamometer. Absolute error for shoulder abduction and flexion at the 30° and 60° was calculated. For the assessment of motor performance in a functional task (reach a glass of water), spatio-temporal parameters (total duration of the motion, peak velocity, time to peak velocity) and three-dimensional joint kinematics of the trunk, scapula, shoulder, and elbow (total range of motion, joint angle maximum and minimum) will be used. Concomitantly, bilateral activation of the deltoid (anterior, middle and posterior), trapezius (upper and lower), serratus anterior and pectoral major will be assessed by electromyography during reach. The following electromyographic variables will be analyzed: activation amplitude, muscle onset and maximum and minimum activation. For statistical analysis, the normality and homogeneity tests will be applied. If the variables have a distribution considered normal and homogeneous, Two-way ANOVA with repeated measures gift will be applied. Otherwise it will be applied to non-parametric statistics Friedman. Will be considered a 0.05 significance level for all statistical tests.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elastic Tape | Active comparator | Other: Elastic tape application in shoulderTape placing will consider as the initial anchor the acromioclavicular joint, and as the final one the point immediately below the insertion of the deltoid muscle. Two centimeters anchor will be considered for all the participants, and the active zone will be equivalent to the distance between two anchors. The first tape will be placed to the anterior portion of the deltoid with the shoulder at 30° passive extension. The second tape will be placed to the middle portion of the deltoid with the shoulder at 30° of passive horizontal adduction. For placing the third tape to the posterior deltoid, the limb will be positioned at 90° of passive flexion of the shoulder. The elastic tape tension will be placed as previously described as "paper tension" and it is equivalent to 10-15% of the total elastic tape tension. |
| Sham | Sham comparator | Other: Elastic tape application in shoulderThe sham elastic tape will be placed using the same tape to the paretic shoulder. However, the rigid tape will be placed without tension with the upper limb supporting at 90 degree elbow flexion, 0 degrees abduction and adduction of the shoulder. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 40 and 70 years and present a minimum score on the Mini Mental State Examination, according to the subject's educational level.
- All subjects must have normal vision or corrected to normal.
- The hemiparetic subjects must present a level of less than 3 spasticity on the Modified Ashworth Scale for shoulder abductor and flexor muscles
- Ability to voluntarily perform the range of motion
- Proper trunk control confirmed by the ability to remain in the seated position without support to the trunk and/or of the arms for 1 minute.
Key exclusion criteria (20 listed)
- diabetes mellitus
- ulcers or skin lesions
- adverse reactions to tape (redness and itching)
- severe cardiovascular or peripheral vascular diseases (heart failure, arrhythmias, angina pectoris, and acute myocardial infarction)
- other neurological or orthopedic diseases
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 |
|---|---|---|
| Elastic tape application in shoulder | Other | Elastic Tape, Sham |
Primary outcome
Change from Baseline in joint sense position (proprioception) at 10 minutes
Time frame: baseline and 10 minutes post-application of placebo ou elastic tape
This analysis will be performed on a dynamometer with the participant seated and blindfolded. Initially, the dynamometer will move the arm participant in references angles. Each subject will be allowed to sense the reference angle for 10 seconds before the upper extremity is returned passively to the start position. Subsequently, the upper extremity will be moved passively by the dynamometer toward the reference position, and subjects will press a button in their hand that will stop the machine when they feel the position has been reached. The absolute error (in degrees) will be calculated as the difference between the indicated and reference positions.
Change from Baseline in joint kinematics of reach at 10 minutes
Time frame: baseline and 10 minutes post-application of placebo ou elastic tape
The Qualisys system will be used for this evaluation. Passive reflective markers will be placed on the anatomical landmarks (anatomical markers) according to the International Society of Biomechanics. In addition, clusters will be placed on the sternum, scapula (most superficial part of the acromion), arm (positioned below the insertion of the deltoid muscle), and forearm (5 cm below the cubital fossa). After positioning the markers and clusters, the collection of static posture (duration 5 seconds) will be performed. In static posture, the individuals should be seated in an adjustable chair. Then, the subject will perform the reaching movement to touch a glass placed at 80% of the length of the upper limb and return to the starting position (pronated hands on the thigh). The variables are calculated: duration of movement (second), speed (mm/s), displacement of the joints of the trunk, scapula, shoulder and elbow (°).
Change from Baseline in Electromyography during the reach at 10 minutes
Time frame: baseline and 10 minutes post-application of placebo ou elastic tape
The collection of electromyographic activity will be performed only during the kinematics of the reaching movement. The electrodes are positioned parallel to the orientation of muscle fibers in the anterior, middle, and posterior deltoid, pectoral major, upper and inferior trapezius, and serratus anterior. Initially, five seconds in the rest position and 10 seconds of EMG activity before the start of the reaching movement will be collected. The following variables will be calculated: activation amplitude, maximum and minimum activation coefficient variation, onset e offset.
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 3 May 2019.
- Results publication: PubMed 21862283Jaspers E, Desloovere K, Bruyninckx H, Klingels K, Molenaers G, Aertbelien E, Van Gestel L, Feys H. Three-dimensional upper limb movement characteristics in children with hemiplegic cerebral palsy and typically developing children. Res Dev Disabil. 2011 Nov-Dec;32(6):2283-94. doi: 10.1016/j.ridd.2011.07.038. Epub 2011 Sep 8.
- Results publication: PubMed 18226659Niessen MH, Veeger DH, Koppe PA, Konijnenbelt MH, van Dieen J, Janssen TW. Proprioception of the shoulder after stroke. Arch Phys Med Rehabil. 2008 Feb;89(2):333-8. doi: 10.1016/j.apmr.2007.08.157.
- Results publication: PubMed 21729974Carda S, Invernizzi M, Baricich A, Cisari C. Casting, taping or stretching after botulinum toxin type A for spastic equinus foot: a single-blind randomized trial on adult stroke patients. Clin Rehabil. 2011 Dec;25(12):1119-27. doi: 10.1177/0269215511405080. Epub 2011 Jul 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic tape application in shoulder in people with Stroke, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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 5 inclusion and 20 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 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Change from Baseline in joint sense position (proprioception) at 10 minutes (time frame: baseline and 10 minutes post-application of placebo ou elastic tape). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02390115, which also lists 3 linked publications.
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 3 May 2019.