NCT05883475

Brief Summary

The purposes of this study is to investigate the differences in upper extremity function, sleep quality, and functional independence between patients with and without hemiplegic shoulder pain (HSP). HSP is defined as musculoskeletal pain in the affected shoulders of individuals after stroke.Numerous studies have found an association between post-stroke shoulder pain and range of motion, sensory impairment, subluxation, spasticity, and complex regional pain syndrome. HSP is a problem that, starting from mild discomfort, leads to gradual functional impairment, ultimately resulting in increasing disability and decreased independence.In the literature, the relationship between HSP and upper extremity function, functional independence, and sleep quality has not been clarified.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

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

June 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

May 16, 2023

Last Update Submit

May 30, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • DASH

    Upper limb functions was assessed with DASH, AMAT, and Nine Hole Peg Test.The DASH total score ranges from 0 to 100, with higher scores indicating a worse upper limb function.

    one hour

  • AMAT

    The increase in the scores of both subparameters of the AMAT scale, which is composed of the parameters of functional ability and quality of movement, indicates an improvement in the motor functions of the upper limbs.

    one hour

  • Nine Hole Peg Test

    In the Nine hole peg test, fine motor skills of the upper extremities decrease as time goes on.

    one hour

Secondary Outcomes (2)

  • Sleep Qaulity

    one hour

  • Functional Independence

    one hour

Study Arms (2)

Patients with shoulder pain

Those who scored above "0" for shoulder pain on the Visual Analog Scale (VAS) were assigned to the group with shoulder pain

Other: Disabilities of the Arm, Shoulder, and Hand QuestionnaireOther: Arm Motor Ability TestOther: Nine Hole Peg TestOther: Pittsburg Sleep Quality IndexOther: Functional Independence Measure

Patients without shoulder pain

Those who scored "0" for shoulder pain on the Visual Analog Scale (VAS) were assigned to the group without shoulder pain

Other: Disabilities of the Arm, Shoulder, and Hand QuestionnaireOther: Arm Motor Ability TestOther: Nine Hole Peg TestOther: Pittsburg Sleep Quality IndexOther: Functional Independence Measure

Interventions

Upper limb function was assessed with the Turkish version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). The questionnaire DASH is a self-report instrument with 30 items. The total score ranges from 0 to 100, with higher scores indicating a worse upper limb function.

Patients with shoulder painPatients without shoulder pain

The test assesses hemiparetic upper extremity functional tasks.The increase in the scores of both subparameters of the scale, which is composed of the parameters of functional ability and quality of movement, indicates an improvement in the motor functions of the upper limbs.

Patients with shoulder painPatients without shoulder pain

Fine motor skills of the upper extremities were assessed.The patient was asked to insert the nine sticks in the box on the table into the holes in the other box as quickly as possible and then remove them immediately. As time increases, fine motor skills of the upper extremities decrease

Patients with shoulder painPatients without shoulder pain

Sleep quality was assessed using the this test.This scale, which provides a quantitative measure of sleep quality, is a 19-item self-report scale. The total score greater than 5 indicates "poor sleep quality".

Patients with shoulder painPatients without shoulder pain

This test assessed functional capacity in activities of daily living.The higher a person's score, the higher the level of independence.

Patients with shoulder painPatients without shoulder pain

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stroke patients

You may qualify if:

  • Over 18 years old
  • Have had a stroke at least three months ago
  • Volunteers who can understand or communicate test instructions

You may not qualify if:

  • Having a history of shoulder surgery
  • Having serious shoulder problems before stroke
  • Having other neurological conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation

Ankara, Esenboğa, 06970, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StrokeShoulder Pain

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2023

First Posted

June 1, 2023

Study Start

June 1, 2022

Primary Completion

October 15, 2022

Study Completion

October 30, 2022

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations