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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04004949
Other study ID # 12341234
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date June 5, 2019

Study information

Verified date August 2020
Source October 6 University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

to investigate the effect of Scapular dyskinesia on the scapular balance angle & upper extremity Sensorimotor Function in spastic stroke patient.


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).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 5, 2019
Est. primary completion date June 5, 2019
Accepts healthy volunteers No
Gender All
Age group 35 Years to 50 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assessment of scapular balance angle and upper extremity sensorimotor function
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).

Locations

Country Name City State
Egypt October 6 University Giza El-Sheikh Zayed City Giza 1133 Egypt

Sponsors (1)

Lead Sponsor Collaborator
Lama Saad El-Din Mahmoud

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
1 day
Primary 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
1 day
Primary 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°
1 day