NCT07885774

Brief Summary

This study was designed to determine the test-retest reliability of the Unsupported Upper Limb Exercise Test (UULEX) in individuals with stroke. Motor impairments following stroke, particularly reductions in upper limb muscle strength, motor control, and functional performance, may adversely affect individuals' activities of daily living and functional independence. Therefore, the assessment of upper limb performance using reliable and feasible methods is important for planning and monitoring the rehabilitation process. The UULEX is an incremental, performance-based, easy-to-administer, and low-cost field test developed to assess upper limb exercise capacity. Although the UULEX has been used in different clinical populations, evidence regarding its test-retest reliability in individuals with stroke is limited. In this study, the UULEX will be administered twice to individuals with stroke at a predetermined interval, and the consistency between the two measurements will be evaluated to determine its test-retest reliability. It is hypothesized that the UULEX will demonstrate high test-retest reliability in individuals with stroke. The findings of this study are expected to provide evidence regarding the reliability of the UULEX as a clinical assessment tool for evaluating upper limb exercise capacity in individuals with stroke.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Oct 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

October 13, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

October 26, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2026

Last Updated

October 21, 2026

Status Verified

September 1, 2026

Enrollment Period

1 month

First QC Date

October 13, 2026

Last Update Submit

October 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Test-Retest Reliability of the Unsupported Upper Limb Exercise Test (UULEX)

    Upper limb exercise capacity will be assessed using the Unsupported Upper Limb Exercise Test (UULEX). Participants will perform progressive unsupported upper limb exercise until symptom limitation or the maximum test duration is reached. UULEX performance will be recorded as total test duration (seconds). The test will be performed three times: twice on the same day with a 1-hour interval and once one week later. Test-retest reliability will be determined by comparing UULEX performance across assessments.

    The UULEX will be administered three times to each participant: the first and second assessments will be performed with a 1-hour rest interval, and the third assessment will be conducted one week later.

Study Arms (1)

Hemiplegia group

Individuals diagnosed with hemiplegia, aged 18-78 years, and willing to participate were included in the study, whereas those with upper extremity or neck pain, cognitive impairment, comorbidities affecting upper extremity and hand function (carpal tunnel syndrome, trigger finger, impingement syndrome, thoracic outlet syndrome, or lateral or medial epicondylitis), or a history of upper extremity surgery were excluded.

Diagnostic Test: Unsupported Upper Limb Exercise Test [UULEX]

Interventions

The UULEX consists of eight horizontal levels positioned 15 cm apart. Participants are seated facing the chart and raise a 0.2-kg bar from hip level to progressively higher levels at a rate of 30 movements per minute using a metronome. After a 2-min warm-up, the level is increased every minute. Once the highest level is reached, the load is increased by 0.5 kg each minute up to 2 kg. The test continues until symptom limitation or a maximum of 12 min. For reliability assessment, the UULEX will be performed three times using the same standardized protocol. The first two assessments will be conducted on the same day with a 1-h rest interval, and the third will be performed one week later.

Hemiplegia group

Eligibility Criteria

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

The study population will consist of adults aged 18-78 years with stroke-related hemiplegia who meet the eligibility criteria and voluntarily agree to participate in the study.

You may qualify if:

  • Diagnosis of hemiplegia
  • Age between 18 and 78 years
  • Willingness to participate in the study

You may not qualify if:

  • Presence of upper extremity or neck pain
  • Cognitive impairment
  • Presence of comorbidities affecting upper extremity and hand function (carpal tunnel syndrome, trigger finger, impingement syndrome, thoracic outlet syndrome, lateral or medial epicondylitis)
  • History of upper extremity surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Takahashi T, Jenkins SC, Strauss GR, Watson CP, Lake FR. A new unsupported upper limb exercise test for patients with chronic obstructive pulmonary disease. J Cardpulm Rehabil. 2003;23:430-437. Lima VP, Velloso M, Almeida FD, Carmona B, Ribeiro-Samora GA, Janaudis-Ferreira T. Test-retest reliability of the unsupported upper-limb exercise test (UULEX) and 6-min peg board ring test (6PBRT) in healthy adult individuals. Physiother Theory Pract. 2018;34(10):806-812. Fulton I, McEvoy M, Pieterse J, Williams M, Thoirs K, Petkov J. Transversus abdominis: changes in thickness during the unsupported upper limb exercise test in older adults. Physiother Theory Pract. 2009;25(8):523-532. Cetin SY, Basakci Calik B, Ayan A, Cavlak U. Validity and reliability of the unsupported upper-limb exercise test in individuals with rheumatoid arthritis. Int J Rheum Dis. 2019 Nov;22(11):2025-2030. doi: 10.1111/1756-185X.13720. Epub 2019 Oct 9. PMID: 31595690. Karazeybek, Z. B., & Naz, İ. (2022). Convergent Validity and Test-Retest Reliability of the Unsupported Upper Limb Exercise Test in Patients with Chronic Neck Pain. Perceptual and Motor Skills, 129(4), 1177-1192.

    BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Nurcan Contarli, Assistant Professor

CONTACT

Study Design

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

Study Record Dates

First Submitted

October 13, 2026

First Posted

October 21, 2026

Study Start (Estimated)

October 26, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 26, 2026

Last Updated

October 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data may be made available from the corresponding author upon reasonable request.