NCT04292613

Brief Summary

"The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

March 5, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2020

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2020

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

5 months

First QC Date

March 1, 2020

Last Update Submit

August 3, 2020

Conditions

Keywords

shoulder pain, hemiplegic, function, balance

Outcome Measures

Primary Outcomes (1)

  • Upper Extremite Fugl-Meyer Assessment (UA-FMA)

    Upper Extremite Fugl-Meyer Assessment (UA-FMA) is a scale that evaluates upper extremity functionality. The total score is at least 0 and at most 66 and the high scores are positively correlated with the normal function.

    1 day (Evaluation will be done once)

Secondary Outcomes (3)

  • McGill Melzack Pain Questionnaire

    1 day (Evaluation will be done once)

  • Short Form- 36

    1 day (Evaluation will be done once)

  • Berg Balance Scale

    1 day (Evaluation will be done once)

Interventions

The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

hemiplegic shoulder pain

You may qualify if:

  • Having had a cerebrovascular accident
  • Ages ranging from 40 to 75
  • Right or left hemiplegic
  • Without mental problems
  • Cooperative
  • According to Brunnstrom staging, upper extremity stage 1-2-3-4-5

You may not qualify if:

  • who do not want to be evaluated
  • Under the age of 40 and over the age of 75
  • Non-cooperative
  • Another orthopedic shoulder problem
  • Newly operated patients will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Therapy and Rehabilitation Training and Research Hospital

Bahçelievler, Istanbul, 34180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Sibel Gayretli Atan

    istanbul physical therapy and rehabilitation training and research hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

March 1, 2020

First Posted

March 3, 2020

Study Start

March 5, 2020

Primary Completion

July 22, 2020

Study Completion

August 3, 2020

Last Updated

August 4, 2020

Record last verified: 2020-08

Locations