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Completed

NCT Number: NCT07723898

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

    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).

Secondary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Factors Affecting Participation in Activities of Daily Living in Individuals With Stroke

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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