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Completed

NCT Number: NCT05883475

Effects of 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.

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Key information

Conditions

Stroke Arthralgia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Ankara, Esenboğa, 06970, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disabilities of the Arm, Shoulder, and Hand Questionnaire

Other

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.

Arm Motor Ability Test

Other

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.

Nine Hole Peg Test

Other

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

Pittsburg Sleep Quality Index

Other

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".

Functional Independence Measure

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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"

  2. 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.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2023
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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