NCT04004949

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

June 28, 2019

Last Update Submit

August 25, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

study group (high scapular dyskinesia )

group A (30 patients): with high scapular dyskinesia scores

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.

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

Interventions

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).

control group (low or no scapular dyskinesia )study group (high scapular dyskinesia )

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University

Giza, El-Sheikh Zayed City Giza 1133 Egypt, Egypt

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of neurology & neurosurgery for physical therapy

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 2, 2019

Study Start

March 1, 2019

Primary Completion

June 5, 2019

Study Completion

June 5, 2019

Last Updated

August 27, 2020

Record last verified: 2020-08

Locations