NCT07723898

Brief Summary

The aim of this study is to identify the factors affecting participation in daily living activities in stroke individuals and their interrelationships. Participation in daily living activities and related factors such as spasticity, upper extremity function, cognitive status, and functional status were assessed in individuals diagnosed with stroke. Hypothesis 1: Spasticity in stroke patients affects participation in daily living activities. Hypothesis 2: Upper extremity function in stroke patients affects participation in daily living activities. Hypothesis 3: Cognitive status in stroke patients affects participation in daily living activities. Hypothesis 4: Functional status in stroke patients affects participation in daily living activities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

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

Study Start

First participant enrolled

September 5, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

July 16, 2026

Last Update Submit

July 22, 2026

Conditions

Keywords

StrokeFunctionalityWalkingActivities of daily livingParticipation

Outcome Measures

Primary Outcomes (1)

  • Stroke Impact Scale (SIS) for assessment of participation in activities of daily living.

    The current SIS 3.0 is a revised version of the original SIS developed by Duncan et al. SIS 3.0 includes 59 items measuring eight domains, including strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation, and one item assessing overall improvement. Items are rated using a Guttman-type scale with five response options. Patients are expected to complete the scale based on the difficulties they perceived last week. Scores of 5, 4, 3, 2, and 1 correspond to the options "not difficult at all," "very little difficult," "somewhat difficult," "very difficult," and "extremely difficult," respectively. Turkish validity and reliability were established by Hantal et al. in 2014, with Cronbachα values \> 0.70 and ICC 0.947 (0.947-0.999).

    The assessment was performed at least 3 months after the stroke.

Secondary Outcomes (10)

  • Muscle tone assessment using the Modified Ashworth Scale (MAS).

    The assessment was performed at least 3 months after the stroke.

  • Nine Hole Peg Test (NHPT) Assessment of upper extremity function

    The assessment was performed at least 3 months after the stroke.

  • Assessment of upper extremity dexterity with Dexterity Questionnaire-24 (DextQ-24)

    The assessment was performed at least 3 months after the stroke.

  • Montreal Cognitive Assessment (MoCA) for cognitive status assessment.

    The assessment was performed at least 3 months after the stroke.

  • Fatigue assessment using the Fatigue Severity Scale (FSS).

    The assessment was performed at least 3 months after the stroke.

  • +5 more secondary outcomes

Study Arms (1)

Individuals with Stroke

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals aged 18-80 diagnosed with stroke who were examined at the neurology outpatient clinic of Pamukkale University Hospitals.

You may qualify if:

  • Having a stroke diagnosis.
  • At least 3 months must have passed since the stroke.
  • Not having hearing, vision, or speech problems that would affect the tests.
  • Agreeing to participate in the study.
  • Not having any non-stroke neurological or orthopedic disease that could affect function.

You may not qualify if:

  • Having undergone musculoskeletal surgery on the upper extremity.
  • Less than 3 months having passed since the stroke.
  • Having hearing, vision, or speech problems severe enough to affect the tests.
  • Having any non-stroke neurological or orthopedic disease that may affect function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

Related Publications (11)

  • Lin KC, Fu T, Wu CY, Hsieh YW, Chen CL, Lee PC. Psychometric comparisons of the Stroke Impact Scale 3.0 and Stroke-Specific Quality of Life Scale. Qual Life Res. 2010 Apr;19(3):435-43. doi: 10.1007/s11136-010-9597-5. Epub 2010 Feb 4.

    PMID: 20127418BACKGROUND
  • Duncan PW, Bode RK, Min Lai S, Perera S; Glycine Antagonist in Neuroprotection Americans Investigators. Rasch analysis of a new stroke-specific outcome scale: the Stroke Impact Scale. Arch Phys Med Rehabil. 2003 Jul;84(7):950-63. doi: 10.1016/s0003-9993(03)00035-2.

    PMID: 12881816BACKGROUND
  • Dönmez S., Dağ H., Kazandı M., Amniyosentez Öncesi Gebelerde Anksiyete ve Depresyon Risk Düzeylerinin Belirlenmesi. Acıbadem Üniversitesi Sağlık Bilimleri Dergisi. 2012;4(3):255-259.

    BACKGROUND
  • Charlson ME, Pompei P, Ales KL, MacKenzie CR. A newmethod of classifyingprognosticcomorbidity in longitudinalstudies: developmentandvalidation. J ChronicDis 1987;40:373-83.

    BACKGROUND
  • Yalın H., İnme Sonrası Hastaların Fonksiyonel Durum, Engellilik Ve Yaşam Kaliteleri. Marmara Üniversitesi Sağlık Bilimleri Enstitüsü. İstanbul. 2011:42-43

    BACKGROUND
  • Gencay-Can A, Can SS. Validation of theTurkishversion of thefatigueseverityscale in patientswithfibromyalgia. RheumatolInt. 2012;32(1):27- 31.

    BACKGROUND
  • Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.

    PMID: 2803071BACKGROUND
  • Çebi M. Mental durum için Kısa Test(STMS) ve MoCA'nınMMSE'ye karşı normal-Alzheimer Hastalığı-Hafif Kognitif Bozukluk Spektrumunda ayrım yeteneğinin karşılaştırılması. Yüksek lisans Tezi, İstanbul Üniversitesi Sağlık Bilimleri Enstitüsü, İstanbul, 2012:23

    BACKGROUND
  • Vanbellingen T, Nyffeler T, Nef T, Kwakkel G, Bohlhalter S, van Wegen EE. Reliability and validity of a new dexterity questionnaire (DextQ-24) in Parkinson's disease. Parkinsonism Relat Disord. 2016 Dec;33:78-83. doi: 10.1016/j.parkreldis.2016.09.015. Epub 2016 Sep 15.

    PMID: 27663063BACKGROUND
  • Erhan B, Gündüz B. Spastisite. Tıbbi rehabilitasyon. 3. Baskı. İstanbul:Nobel Tıp Kitapevleri. 2015:565-573

    BACKGROUND
  • Mathiowetz V, Weber K, Kashman N et al. Adultnormsfor nine hole peg test of fingerdexterity. TheOccupTher J. Res. 1983;5(1):25-38.

    BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nilüfer ÇETİŞLİ KORKMAZ, PT.PhD.Prof.

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, MSc

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 23, 2026

Study Start

September 5, 2020

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared. The dataset contains sensitive clinical information obtained from individuals who have experienced a stroke. Due to ethical considerations, participant confidentiality, and institutional requirements regarding the protection of personal health information, individual-level data sharing is not planned.

Locations