Post Stroke Scapular DyskinesiaNCT04004949
the Effect of Scapular Dyskinesia on the Scapular Balance Angle & Upper Extremity Sensorimotor Function in Spastic Stroke Patient. The Patients Were Diagnosed With the Lateral Scapular Slide Test, Fugl-Meyer Upper Extremity (FMUE) Scale Scores & Scapular Balance Angle Test (SBA).
An observational study of Post Stroke Scapular Dyskinesia, run by Lama Saad El-Din Mahmoud at 1 site in Egypt.
Trial summary
to investigate the effect of Scapular dyskinesia on the scapular balance angle \& upper extremity Sensorimotor Function in spastic stroke patient. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Post Stroke Scapular Dyskinesia
- What is being tested?
- Assessment of scapular balance angle and upper extremity sensorimotor function
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 5 Jun 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Sixty stroke patients were randomly selected from Kasr El-Aini Neurological Department, outpatient clinic of Faculty of Physical Therapy, Cairo University, October 6 university hospital.
Who may be able to join
- patient diagnosed as stroke patient
- stroke onset at least 5 months prior to study enrollment and
- decreased sensorimotor function in the affected arm, but ability to use the arm to some extent in daily activities with functional to subfunctional manual muscle test
- age ranged from 35:50
- both sexes
Who cannot join
- difficulty to communicate or to understand test instructions
- other conditions that caused pain (for example fibromyalgia and arthritis)
- severe depression or other psychiatric symptoms
- patient with other upper limb musculoskeletal problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Scapular Dyskinesia on the Scapular Balance Angle & Upper Extremity Sensorimotor Function in Stroke Patients With Spasticity
to investigate the effect of Scapular dyskinesia on the scapular balance angle \& upper extremity Sensorimotor Function in spastic stroke patient.
Read the detailed description
Background: Post stroke Scapular dyskinesia leads to scapulohumeral pain \& dysfunction were associated with decreased motor function, somatosensory function, limited range of motion, and spasticity.
Objective: to investigate the effect of Scapular dyskinesia on the scapular balance angle \& upper extremity Sensorimotor Function in spastic stroke patient.
Methods: sixty patients from both sexes were participated in this study. All the patients were diagnosed as spastic stroke patients. The patients were divided into two equal groups; group A (30 patients): with high scapular dyskinesia scores, group B (30 patients): with low or no scapular dyskinesia scores. The patients were diagnosed with the Lateral scapular slide test using Palpation meter (PALM) device, Fugl-Meyer upper extremity (FMUE) Scale scores \& scapular balance angle test (SBA).
- Conditions
- Post Stroke Scapular Dyskinesia
- Being tested
- Assessment of scapular balance angle and upper extremity sensorimotor function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of scapular balance angle and upper extremity sensorimotor functionOther
The patients were diagnosed with the Lateral scapular slide test using Palpation meter (PALM) device, Fugl-Meyer upper extremity (FMUE) Scale scores \& scapular balance angle test (SBA).
| Study group | Role | What they receive |
|---|---|---|
| study group (high scapular dyskinesia ) | group A (30 patients): with high scapular dyskinesia scores Receives: Other: Assessment of scapular balance angle and upper extremity sensorimotor function | |
| control group (low or no scapular dyskinesia ) | group B (30 patients): with low or no scapular dyskinesia scores. (30 patients): with low or no scapular dyskinesia scores. Receives: Other: Assessment of scapular balance angle and upper extremity sensorimotor function |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Lateral scapular slide test
for the measurement of scapular dyskinesia, the Lateral scapular slide test using Palpation meter (PALM) device,
marked inferior angles of scapula and the other arm was moved to reach the marked corresponding spinous process Both sides' readings were recorded and the differences between them were calculated
Bilateral difference of 1.5 cm considered the threshold for deciding whether scapular asymmetry is abnormal A distance 1.5 cm greater than the contralateral side in any position suggests scapulothoracic weakness with secondary scapulothoracic protraction
Measured: 1 day
Fugl-Meyer Assessment (FMA) scale
Fugl-Meyer upper extremity (FMUE) Scale scores is an index to assess the sensorimotor impairment in individuals who had stroke.
The motor section score ranges from 0 to 66, and the score related to exteroceptive and proprioceptive sensitivity ranges from 0 to 12. The lowest and highest scores correspond to worse and better function, respectively FMUE Scale scores < 31 corresponded with 'no to poor' upper extremity capacity, while 32 to 47 represented 'limited capacity', 48 to 52 represented 'notable capacity' and 53 to 66 represented 'full' upper extremity capacity
Measured: 1 day
scapular balance angle (SBA):
for Measurement of scapular balance angle
The inferior angle of the scapula was marked bilaterally and a line was drawn connecting these marks. Another vertical line between C7 and T10 spinous processes was drawn. The angles formed by the line joining both inferior angles of the scapula with the vertical line running through the spine were measured (The difference between these two angles corresponded to the scapular balance angle The values for the SBA in healthy population were 2.505±2.340° while the abnormality criteria were with an angle greater than 7.185°
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Mar 2019
- Primary completion5 Jun 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke Scapular DyskinesiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Lama Saad El-Din Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lama Saad El-Din Mahmoud, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004949
- Sponsor's protocol ID
- 12341234
- Status last verified
- Aug 2020
- First submitted
- 28 Jun 2019
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: publication research study
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Scapular Dyskinesia on the Scapular Balance Angle & Upper Extremity Sensorimotor Function in Stroke Patients With Spasticity
- ClinicalTrials.gov ID
- NCT04004949
- Acronym / sponsor ID
- 12341234
- Conditions
- Post Stroke Scapular Dyskinesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lama Saad El-Din MahmoudUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 2 Jul 2019 (actual)
- 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.
to investigate the effect of Scapular dyskinesia on the scapular balance angle \& upper extremity Sensorimotor Function in spastic stroke patient.
Detailed description
Background: Post stroke Scapular dyskinesia leads to scapulohumeral pain \& dysfunction were associated with decreased motor function, somatosensory function, limited range of motion, and spasticity.
Objective: to investigate the effect of Scapular dyskinesia on the scapular balance angle \& upper extremity Sensorimotor Function in spastic stroke patient.
Methods: sixty patients from both sexes were participated in this study. All the patients were diagnosed as spastic stroke patients. The patients were divided into two equal groups; group A (30 patients): with high scapular dyskinesia scores, group B (30 patients): with low or no scapular dyskinesia scores. The patients were diagnosed with the Lateral scapular slide test using Palpation meter (PALM) device, Fugl-Meyer upper extremity (FMUE) Scale scores \& scapular balance angle test (SBA).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group (high scapular dyskinesia ) | – | Other: Assessment of scapular balance angle and upper extremity sensorimotor functiongroup A (30 patients): with high scapular dyskinesia scores |
| control group (low or no scapular dyskinesia ) | – | Other: Assessment of scapular balance angle and upper extremity sensorimotor functiongroup B (30 patients): with low or no scapular dyskinesia scores. (30 patients): with low or no scapular dyskinesia scores. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Sixty stroke patients were randomly selected from Kasr El-Aini Neurological Department, outpatient clinic of Faculty of Physical Therapy, Cairo University, October 6 university hospital.
Key inclusion criteria (5 listed)
- patient diagnosed as stroke patient
- stroke onset at least 5 months prior to study enrollment and
- decreased sensorimotor function in the affected arm, but ability to use the arm to some extent in daily activities with functional to subfunctional manual muscle test
- age ranged from 35:50
- both sexes
Key exclusion criteria (4 listed)
- difficulty to communicate or to understand test instructions
- other conditions that caused pain (for example fibromyalgia and arthritis)
- severe depression or other psychiatric symptoms
- patient with other upper limb musculoskeletal problems
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 scapular balance angle and upper extremity sensorimotor functionThe patients were diagnosed with the Lateral scapular slide test using Palpation meter (PALM) device, Fugl-Meyer upper extremity (FMUE) Scale scores \& scapular balance angle test (SBA). | Other | control group (low or no scapular dyskinesia ), study group (high scapular dyskinesia ) |
Primary outcome
the Lateral scapular slide test
Time frame: 1 day
for the measurement of scapular dyskinesia, the Lateral scapular slide test using Palpation meter (PALM) device, marked inferior angles of scapula and the other arm was moved to reach the marked corresponding spinous process Both sides' readings were recorded and the differences between them were calculated Bilateral difference of 1.5 cm considered the threshold for deciding whether scapular asymmetry is abnormal A distance 1.5 cm greater than the contralateral side in any position suggests scapulothoracic weakness with secondary scapulothoracic protraction
Fugl-Meyer Assessment (FMA) scale
Time frame: 1 day
Fugl-Meyer upper extremity (FMUE) Scale scores is an index to assess the sensorimotor impairment in individuals who had stroke. The motor section score ranges from 0 to 66, and the score related to exteroceptive and proprioceptive sensitivity ranges from 0 to 12. The lowest and highest scores correspond to worse and better function, respectively FMUE Scale scores < 31 corresponded with 'no to poor' upper extremity capacity, while 32 to 47 represented 'limited capacity', 48 to 52 represented 'notable capacity' and 53 to 66 represented 'full' upper extremity capacity
scapular balance angle (SBA):
Time frame: 1 day
for Measurement of scapular balance angle The inferior angle of the scapula was marked bilaterally and a line was drawn connecting these marks. Another vertical line between C7 and T10 spinous processes was drawn. The angles formed by the line joining both inferior angles of the scapula with the vertical line running through the spine were measured (The difference between these two angles corresponded to the scapular balance angle The values for the SBA in healthy population were 2.505±2.340° while the abnormality criteria were with an angle greater than 7.185°
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 27 Aug 2020.
- Individual participant dataSharing planned: Undecided. publication research study
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?
An observational study of Post Stroke Scapular Dyskinesia, run by Lama Saad El-Din Mahmoud at 1 site in Egypt.
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 4 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 27 Aug 2020. 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 Egypt. 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. 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?
the Lateral scapular slide test (time frame: 1 day). 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?
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 27 Aug 2020.