NCT06447649

Brief Summary

The aim of this study was to examine the factors affecting shoulder pain in stroke survivors and to determine how much the factors affect shoulder pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

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

December 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2021

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

1.4 years

First QC Date

May 31, 2024

Last Update Submit

June 6, 2024

Conditions

Keywords

FunctionalityHemiplegic Shoulder PainStrokeMuscle ToneRehabilitation

Outcome Measures

Primary Outcomes (7)

  • Visual Analog Scale (VAS)

    Visual Analog Scale (VAS) used to asses shoulder pain of stroke survivors. The patient will be asked to indicate the point on a 10 cm line that best represents their pain, with 0 indicating no pain and 10 indicating unbearable pain. Subsequently, the distance of the point from the 0 point will be measured using a ruler to determine the intensity of the pain. Following this, the patient will be inquired about the localization and type of pain.

    1 year

  • Modified Ashworth Scale (MAS)

    Modified Ashworth Scale (MAS) used to evaluated of muscle tone. A scale commonly used for spasticity assessment in clinical settings. The initial form, known as the Ashworth Scale, categorizes the resistance of the extremity to passive movement within a range of 0-4 points. Subsequently, the scale includes a value of 1+, defining it as the 6-point Modified Ashworth Scale. (9) According to MAS

    1 year

  • Fugl Meyer Motor Assesment Scale (FMMAS)

    Fugl Meyer Motor Assesment Scale (FMMAS) was employed to evaluate motor recovery after a stroke, it is a disease-specific, reliable, and up-to-date scale. It includes sub-sections assessing joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score achievable from the upper extremity assessment is 66,

    1 year

  • Neer Impingement Test

    Neer Impingement Test was used to identify possible subacromial impingement syndrome. The patient's shoulder is passively brought into flexion and internal rotation position. The positive examination finding is the occurrence of shoulder pain during the movement of the arm in this position. The test has a sensitivity of 68% and a specificity of 68.7%.

    1 year

  • Speed Test

    Speed Test was used to identify possible biceps tendon pathologies. When shoulder flexion is performed against resistance with the elbow extended and the forearm supinated, the presence of pain in the bicipital groove indicates a positive test.

    1 year

  • Acromioclavicular Shear Test

    Acromioclavicular Shear Test was used to identify acromioclavicular joint pathology. The examiner cups their hands over the shoulder with the heel of one hand on the clavicle, and the heel of the other on the spine of the scapula, and then squeeze their hands together. A positive result is abnormal movement or pain at the acromioclavicular joint. The test has a sensitivity of 100% and a specificity of 97%

    1 year

  • Apprehension Test

    Apprehension Test was used to detect the presence of anterior instability. As the shoulder is passively moved into maximum external rotation in abduction, and forward pressure is applied to the posterior aspect of the humeral head. If the patient expresses concern about dislocation or reports pain in the shoulder, the test is considered positive. The test has a sensitivity of 58% and a specificity of 96%

    1 year

Study Arms (1)

study group

We included stroke patients aged between 20 and 85. inclusion criteria for this study; having received a diagnosis of hemiplegia following a cerebrovascular accident (CVA), having experienced a first-time stroke, having unilaterally affected, having stage 3 or above Brunnstrom upper limb stage, not having any other neurological/orthopedic problems in addition to hemiplegia, not having any shoulder problems on the same side (affected side) before the stroke, scoring 25 or above on the Mini Mental Test.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

stroke patients treated in the Physical Therapy and Rehabilitation Unit of Pamukkale University Faculty of Medicine Hospital. We conducted patient selection through screening using the Probel system, and randomly assigned patients who met the inclusion criteria and agreed to participate in the study using a random number table.

You may qualify if:

  • having received a diagnosis of hemiplegia following a cerebrovascular accident (CVA)
  • having experienced a first-time stroke
  • having unilaterally affected, having stage 3 or above Brunnstrom upper limb stage
  • not having any other neurological/orthopedic problems in addition to hemiplegia
  • not having any shoulder problems on the same side (affected side) before the stroke
  • not having any shoulder problems on the same side (affected side) before the stroke

You may not qualify if:

  • having a history of shoulder injury (affected side)
  • neurological and orthopedic diseases other than stroke
  • prior stroke
  • bilateral involvement
  • non-cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 7, 2024

Study Start

December 1, 2019

Primary Completion

April 28, 2021

Study Completion

April 28, 2021

Last Updated

June 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations