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StrokeNCT07723898

Factors Affecting Participation in Daily Living in Stroke: Roles of Spasticity, Upper Extremity, Cognition and Function

An observational study of Stroke, run by Pamukkale University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
How many people
49 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Sep 2020to 30 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Pamukkale University

    Denizli, 20070

Other trials in Turkey (Türkiye)

About this study

Official title: Factors Affecting Participation in Activities of Daily Living in Individuals With Stroke

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.

Read more

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.

Conditions
Stroke
Keywords
Stroke, Functionality, Walking, Activities of daily living, Participation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07723898
Study groupRoleWhat they receive
Individuals with StrokeNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (10)
  1. Muscle tone assessment using the Modified Ashworth Scale (MAS).

    This scale evaluates the resistance encountered during passive movement of an extremity with a score range of 0-4. The Ashworth scale provides information about the velocity-dependent change in spasticity around a joint. The Ashworth scale is a subjective assessment method widely used in grading spasticity in muscle tone disorders. In 1987, Bohannon et al. developed the MAS by adding 1+ to the Ashworth Scale to better evaluate elbow flexors in hemiplegic patients. According to the MAS: 0: no increase in muscle tone; 1: minimal resistance felt at the end of the range of motion (ROM) or presence of a catch-and-release sensation when the affected parts are brought into flexion or extension; 1+: pulling sensation during movement, resistance felt in less than half of the ROM; 2: felt in most of the ROM, but the affected part is easily moved; 3: passive movement is difficult throughout the ROM; 4: the affected part is rigid in flexion or extension.

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

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

    It is a test that measures upper extremity functions (hand and arm) and motor speed. The test materials consist of a board with nine round holes and nine cylindrical wooden sticks. Patients are asked to quickly take nine nails from the storage box, place them randomly in the holes without any prior order, and then quickly remove them from the holes and place them back in the storage box without interruption. The total time taken to insert and remove the sticks from the holes is measured in seconds by a stopwatch. This is a standardized, valid and reliable test. The test is performed twice in a row for both hands, and the average of the results is taken. The total test score is found by taking the average of the scores obtained for both hands.

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

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

    This is a 24-question questionnaire designed to assess manual dexterity. The 24 questions (12 single-handed, 12 double-handed) are divided into five subgroups: washing/combing, dressing, cooking and kitchen, daily tasks, and TV/CD/DVD. For each subgroup, the questions are scored as follows: indicating whether the patient has no problems (1 point), indicating occasional problems (2 points), indicating frequent problems but still without external assistance (3 points), and being unable to complete the task and needing help from a third party (4 points). The minimum total score is 24, and the maximum is 96. An increase in the score indicates decreased manual dexterity. Turkish validity and reliability were established by Korkmaz et al., with an ICC value of 0.96 (0.928-0.978) and a Cronbach's alpha value of 0.965.

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

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

    MoCA is a rapid screening test developed by Nasreddine et al. (2005) specifically for Mild Cognitive Impairment and assesses various cognitive functions. The Turkish adaptation was carried out at the Department of Neurology, Hacettepe University, with an ICC value of 0.742 and Cronbach's alpha values of 0.664 and 0.752 for patients and healthy controls, respectively (19). The functions assessed in MoCA are attention and concentration, executive functions, memory, language, visual structuring skills, abstract thinking, calculation, and orientation. The MoCA takes approximately 10 minutes to administer. The highest possible total score on the test is 30.

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

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

    The Fatigue Severity Scale was developed by Krupp et al., and its Turkish validity and reliability study was conducted by Armutlu et al. The scale consists of 9 questions about fatigue, and patients are asked to rate each question on a scale of 1 (strongly disagree) to 7 (strongly agree). The total score on the Fatigue Severity Scale can range from a minimum of 9 to a maximum of 63.

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

  6. Assessment of balance using the Berg Balance Scale (BBS).

    This is a scale that includes 14 general balance activities, such as transitioning from a sitting to a standing position, turning while standing, picking up an object from the ground while standing, 360-degree rotation, and standing on one leg. The patient's performance is observed for each activity, and a score of 0-4 is given. If the patient cannot perform the activity, a score of 0 is given; if the patient performs the activity independently, a score of 4 is given. Lower scores indicate impaired balance. The highest total score is 56, with scores of 0-20 indicating impaired balance, 21-40 indicating acceptable balance, and 41-56 indicating good balance.

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

  7. Gait assessment using the Time Up and Go Test (TUG).

    The participant is assessed by an observer as they stand up from a seated position without holding onto the chair's arms, walk 3 meters, return without touching anything, walk back to the chair, and sit down again. The time is recorded in seconds (s). The test is initiated with the patient's feet flat on the floor and their arms resting on the chair's armrests. Three repetitions are performed, and the best result is recorded.

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

  8. Functional status assessment using the Modified Rankin Scale (mRS).

    The Modified Rankin Scale is a frequently used scale for assessing the functional status of stroke patients. This scale classifies the disability that develops after a stroke into six grades, scored from 0 to 5. No findings are scored as "0," while severe disability or bedridden dependence is scored as "5." A mRS score of two or below indicates a good end-of-life, while a score above two indicates a poor end-of-life.

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

  9. Comorbidity assessment using the Charlson Comorbidity Index (CCI)

    The Charlson Comorbidity Index is an index used to identify comorbidities in surgical or internal medicine problems. It contains a total of 19 items, and for each item, options for 'yes' and 'no' are marked.

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

  10. Assessment of emotional state using Hospital Anxiety Depression Measure (HAD).

    This scale is used not for diagnosis in patients with physical illnesses and those seeking primary care, but to quickly identify anxiety and depression and determine risk groups. Seven of the 14 questions (odd numbers) measure anxiety and seven (even numbers) measure depression. Responses are given on a four-point Likert scale, scored from 0 to 3. Each item has a different score. Items 1, 3, 5, 6, 8, 10, 11, and 13 show decreasing severity and are scored as 3, 2, 1, 0. On the other hand, items 2, 4, 7, 9, 12, and 14 are scored as 0, 1, 2, 3. The lowest possible score for patients is 0, and the highest is 21.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2026
  2. Study start5 Sep 2020
  3. Primary completion30 Apr 2022
  4. Study completion30 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07723898
Sponsor's protocol ID
60116787-020/50461
Status last verified
Jul 2026
First submitted
16 Jul 2026
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 20127418
  • 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.

    PubMed 12881816
  • 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.

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

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

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

  • 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.

    PubMed 2803071
  • 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

  • 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.

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

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

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Pamukkale University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stroke Impact Scale (SIS) for assessment of participation in activities of daily living. (time frame: The assessment was performed at least 3 months after the stroke.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07723898, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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