NCT05907876

Brief Summary

Hemiplegia refers to a complete paralysis involving one side of the arm, trunk and leg. Stroke causes loss of ability and leads to loss of functionality of daily life activities of individuals. Changes in the anatomy of the joint should be analysed for a better understanding of upper extremity problems, especially shoulder problems and pain after stroke. In recent years, the prevalence of shoulder pain in haemiplegic patients has ranged between 5% and 84%. Shoulder pain makes movements of the upper limb difficult and affects gait. Lack of active movement and spasticity is an important cause of shoulder pain. Pain and changes in muscle tone affect upper limb functionality by 30-66%. Improvement in shoulder pain with the recovery of upper extremity functions is important in returning the person to active life independently, as well as obtaining effective hand function. There are many clinical tests used to evaluate upper extremity functionality after haemiplegia. One of them, the Unassisted Upper Extremity Exercise Test (UULEX), is a performance test that evaluates upper extremity performance. The unsupported upper extremity exercise test (UULEX) is a simple, inexpensive field test developed to measure upper arm exercise capacity, but there are no reports on its reliability for use in patients with hemiplegia. The aim of our study was to determine the test-retest reliability of the UULEX in stroke patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

June 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1 month

First QC Date

June 8, 2023

Last Update Submit

June 16, 2023

Conditions

Keywords

STROKEUULEXUPPER EXTREMITY

Outcome Measures

Primary Outcomes (1)

  • Upper Limb Functionality

    It will be evaluated using UULEX.

    First Day

Interventions

UULEX uses a table of horizontal parallel lines with 8 levels. Each level is 84 cm wide and 8 cm high. The distance between the levels is 15 cm. The subject is seated on a straight chair with his/her feet on the floor facing the wall with the UULEX table. He/she holds a bar weighing 0.2 kg and lifts the bar at hip level. Keeping his/her arms shoulder-width apart, he/she raises the bar to different levels of the chart. As a warm-up, he/she is instructed to raise the bar to the first level and hold this position for 2 minutes. Then the bar is moved to each level and the levels are increased for 1 minute. The starting and ending point of each level is the hip joint. As the exercise progresses each minute, the weight of the bar is increased by 0.5 kg up to a maximum of 2 kg. During the test, a subject can move up to a maximum of a 2kg bar in a maximum of 12 minutes. The subject is instructed to continue the test until limited by the occurrence of symptoms.

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with stroke receiving rehabilitation services in a rehabilitation centre

You may qualify if:

  • Having had a stroke
  • Diagnosis of haemiplegia after a previous stroke
  • Being between 18-78 years old
  • Volunteering to participate in the study

You may not qualify if:

  • Presence of pain in the upper limbs or neck
  • Cognitive disorders
  • Presence of comorbidity affecting upper extremity and hand functions (carpal tunnel syndrome, trigger finger, impingement syndrome, thoracic outlet syndrome, lateral and medial epicondylitis)
  • History of upper extremity surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Fatma Hale Altınkaya

    Karabuk University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
INVESTIGATOR

Study Record Dates

First Submitted

June 8, 2023

First Posted

June 18, 2023

Study Start

October 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share