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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05883475
Other study ID # 963
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date October 30, 2022

Study information

Verified date May 2023
Source Ankara Yildirim Beyazit University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date October 30, 2022
Est. primary completion date October 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Disabilities of the Arm, Shoulder, and Hand Questionnaire
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
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
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
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
This test assessed functional capacity in activities of daily living.The higher a person's score, the higher the level of independence.

Locations

Country Name City State
Turkey Ankara Yildirim Beyazit University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation Ankara Esenboga

Sponsors (1)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Sleep Qaulity 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
Secondary Functional Independence 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
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