Effects of Hemiplegic Shoulder Pain

May 30, 2023 updated by: Ankara Yildirim Beyazıt University

Investigation of Upper Extremity Function, Sleep Quality, and Functional Independence in Patients With Hemiplegic Shoulder Pain

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Esenboğa
      • Ankara, Esenboğa, Turkey, 06970
        • Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Stroke patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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.
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
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".
This test assessed functional capacity in activities of daily living.The higher a person's score, the higher the level of independence.
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
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.
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.
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
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".
This test assessed functional capacity in activities of daily living.The higher a person's score, the higher the level of independence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASH
Time Frame: one hour
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
Time Frame: one hour
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
Time Frame: one hour
In the Nine hole peg test, fine motor skills of the upper extremities decrease as time goes on.
one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Qaulity
Time Frame: one hour
Sleep quality was assessed using the Pittsburg Sleep Quality Index (PSQI). The total score ranges from 0 to 21, and a total score greater than 5 indicates "poor sleep quality"
one hour
Functional Independence
Time Frame: one hour
The Functional Independence Measure (FIM) assessed functional capacity in activities of daily living. The FIM Consists of 6 parts and analyzes motor and cognitive functions. The higher a person's score, the higher the level of independence.
one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

October 15, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 963

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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