StrokeNCT05133219
The Effect of ıntensified Sensory-based Therapy on Upper Extremity Functions and Activities of Daily Living
A study testing Occupational Therapy in people with Stroke and Sensory Defect, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Sensory dysfunction following stroke is a common condition. The deficiency in the somatosensory system negatively affects the learning of new motor skills by preventing feedback from the sensory system, and it can also cause problems in daily life, personal care, productivity, and leisure activities. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Sensory Defect
- What is being tested?
- Occupational Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 May 2022to 2 Sep 2022
- Phase
- Interventional
- 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
Who may be able to join
- Stroke duration more than 6 months,
- To be able to communicate
- 10 degrees of wrist dorsiflexion starting from full palmar flexion of the wrist
- To initiate finger extension
Who cannot join
- Joint contracture in the upper and lower extremities that will affect functionality other than stroke,
- Having a significant uncontrolled health problem and a history of epileptic seizures,
- Having 3 or more spasticity according to the Modified Ashworth Scale (MAS),
- Unable to communicate and cooperate,
- With marked ataxia and dystonia,
- Lack of movement and function in the wrist and fingers
- Having a diagnosis of bilateral stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of ıntensified Sensory-based Therapy on Upper Extremity Functions and Activities of Daily Living in Patients With Chronic Stroke
Sensory dysfunction following stroke is a common condition. The deficiency in the somatosensory system negatively affects the learning of new motor skills by preventing feedback from the sensory system, and it can also cause problems in daily life, personal care, productivity, and leisure activities. Somatosensory impairment is often overlooked, as rehabilitation often focuses on motor abilities in the affected extremity. In the studies reviewed, it is stated that sensory dysfunction is seen in approximately 50% of stroke patients.
The aim of this study is to examine the effects of intensified sensory-based therapy applied to the affected upper extremity sensory functions in individuals with chronic stroke on the upper extremity functions, quality of life, and independence of daily living activities.
Read the detailed description
Sensory dysfunction following stroke is a common condition. The deficiency in the somatosensory system negatively affects the learning of new motor skills by preventing feedback from the sensory system, and it can also cause problems in daily life, personal care, productivity, and leisure activities. Somatosensory impairment is often overlooked, as rehabilitation often focuses on motor abilities in the affected extremity. In the studies reviewed, it is stated that sensory dysfunction is seen in approximately 50% of stroke patients.
The aim of the study; The aim of this study is to examine the effects of intensified sensory-based therapy applied to the affected upper extremity sensory functions in individuals with chronic stroke on the upper extremity functions, quality of life, and independence of daily living activities.
Thirty patients with chronic stroke will be randomized 1:1 to study (n:15) and control (n=12). Thumb localization test, finger swipe test, stereognosis test, and two-point discrimination test will be used to evaluate the sensory functions of individuals. Demographic information of individuals will be recorded with a sociodemographic information form. Before the treatment, the sensory levels of all patients will be determined by thumb localization, finger scrolling and stereognosy tests. Jebsen Taylor Hand Function Test (JTHFT), Modified Frenchay Scale (MFS), Canadian Occupational Performance Measure (COPM), Goal Attainment Scale (GAS) and Stroke-Specific Quality of Life Scale (SSQOL) will be administered before and after treatment.
- Conditions
- Stroke, Sensory Defect
- Being tested
- Occupational Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyOther
Also called Activities of Daily Living Training, İntensified Sensory Therapy
Occupational therapy is the only profession that helps people across the lifespan to do the things they want and need to do through the therapeutic use of daily activities (occupations). Occupational therapy practitioners enable people of all ages to live life to its fullest by helping them promote health, and prevent-or live better with-injury, illness, or disability.
| Study group | Role | What they receive |
|---|---|---|
| Research Group | Experimental | Participants will be received Intensified sensory therapy.
Other: Occupational Therapy Activities of Daily Living Training
Intervention: Other: Occupational therapy intervention Receives: Other: Occupational Therapy |
| Control Group | Experimental | Participants will be received Occupational Therapy.
Other: Activities of Daily Living Training Receives: Other: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM)- Satisfaction
Used to evaluate participants' self-perceived satisfaction with performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their satisfaction of how well they are able to complete each task on a scale of 1 (unsatisfied) to 10 (completely satisfied). Total scores are an mean of individual task scores and also range from 1 (unsatisfied) to 5 (completely satisfied). Collected data will be used to measure changes within and between groups on self-perceived satisfaction with performance between week 1 and 8, week 1 and 3.
Measured: 3 weeks
Canadian Occupational Performance Measure (COPM)- Performance
Used to evaluate participants' self-perceived functional performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their perception of how well they are able to complete each task on a scale of 1 (unable to perform) to 10 (able to perform extremely well). Total scores are an mean of individual task scores and also range from 1 (unable to perform tasks) to 5 (able to perform tasks extremely well). Collected data will be used to measure changes within and between groups on self-perceived performance between week 1 and 3.
Measured: 3 weeks
Jebsen Taylor Hand Function Test (JTHFT)
The JTHFT is a common and detailed clinical assessment for fine motor skills with weighted and non-weighted hand functions. The test is derived from activities of daily routine and consists of writing a standardized sentence, turning over 5 cards, picking up and replacing small objects; simulated eating using a spoon and 5 kidney beans, stacking 4 draughts pieces on a board, turning over 5 large empty tins and turning over 5 full tins.
Measured: 3 weeks
The Modified Frenchay Scale (MFS)
The Modified Frenchay Scale (MFS) measures active upper limb function in hemiparesis based on a video review of 10 everyday living tasks, each rated on a 10-point visual analogic scale. Six tasks are bimanual and four are unimanual performed with the paretic hand. We will measured intra- and inter-rater reliability of MFS in hemiparetic patients among trained raters.
Measured: 3 weeks
Secondary outcomes (5)
The Stroke Specific Quality Of Life Scale (SSQOL)
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with Stroke.
To assess the quality of life of stroke patients, Williams et al. The Stroke Specific Quality of Life Scale (SSQOL) created by the Institute will be used. The SSQOL consists of 12 subsections, including energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision and work/productivity, and a total of 49 questions; It is graded with a Likert-type scoring ranging from 1 to 5.
Measured: 3 weeks
Sensory Test- Stereognosy Test
Patients can easily recognize when their eyes are closed; 12 objects including water bottle, glass, scissors, paper, key, pen, glove, ruler, telephone, ball, fork and spoon were evaluated according to their naming. Patients will be evaluated in 2 groups as normal recognizing 7-12 objects and decreased recognizing 7 or less objects.
Measured: 3 weeks
Sensory Test- Finger Shift Test
By looking at the patient's ability to distinguish up and down passive movement of the proximal thumb joint while his eyes are closed; decreased and will be considered normal.
Measured: 3 weeks
Sensory Test- Thumb Localization Test
The patient was asked to localize the affected side with his good hand while his eyes were closed; decreased and will be considered normal.
Measured: 3 weeks
Goal Attainment Scaling (GAS)
GAS served as the primary outcome measure. Once a patient has identified a goal area, GAS goals are established using a 5-point scale, with ''0'' reflecting a score indicating the patient met his or her goal as expected; scores of +1 or +2 indicate surpassing the desired goal, and -1 or -2 indicate inadequate goal attainment. Each potential score (i.e. -2, -1, 0, +1, +2) is based on a criterion that is established collaboratively with the patient and is measurable and specific.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start23 May 2022
- Primary completion8 Aug 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Rohat YAZICI, Kocaeli University
- Investigators
- Çiğdem ÇEKMECE, PhD, Study chair, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133219
- Sponsor's protocol ID
- KOU-MRYAZİCİ-001
- Status last verified
- Sep 2022
- First submitted
- 9 Sep 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yazici MR, Cekmece C. The efficacy of intensified sensory therapy on upper extremity functions and activities of daily living in patients with chronic stroke: A randomized controlled trial. Pak J Med Sci. 2026 Jan;42(1):161-167. doi: 10.12669/pjms.42.1.11940.
PubMed 41737162
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of ıntensified Sensory-based Therapy on Upper Extremity Functions and Activities of Daily Living in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT05133219
- Acronym / sponsor ID
- KOU-MRYAZİCİ-001
- Conditions
- Stroke, Sensory Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sensory dysfunction following stroke is a common condition. The deficiency in the somatosensory system negatively affects the learning of new motor skills by preventing feedback from the sensory system, and it can also cause problems in daily life, personal care, productivity, and leisure activities. Somatosensory impairment is often overlooked, as rehabilitation often focuses on motor abilities in the affected extremity. In the studies reviewed, it is stated that sensory dysfunction is seen in approximately 50% of stroke patients.
The aim of this study is to examine the effects of intensified sensory-based therapy applied to the affected upper extremity sensory functions in individuals with chronic stroke on the upper extremity functions, quality of life, and independence of daily living activities.
Detailed description
Sensory dysfunction following stroke is a common condition. The deficiency in the somatosensory system negatively affects the learning of new motor skills by preventing feedback from the sensory system, and it can also cause problems in daily life, personal care, productivity, and leisure activities. Somatosensory impairment is often overlooked, as rehabilitation often focuses on motor abilities in the affected extremity. In the studies reviewed, it is stated that sensory dysfunction is seen in approximately 50% of stroke patients.
The aim of the study; The aim of this study is to examine the effects of intensified sensory-based therapy applied to the affected upper extremity sensory functions in individuals with chronic stroke on the upper extremity functions, quality of life, and independence of daily living activities.
Thirty patients with chronic stroke will be randomized 1:1 to study (n:15) and control (n=12). Thumb localization test, finger swipe test, stereognosis test, and two-point discrimination test will be used to evaluate the sensory functions of individuals. Demographic information of individuals will be recorded with a sociodemographic information form. Before the treatment, the sensory levels of all patients will be determined by thumb localization, finger scrolling and stereognosy tests. Jebsen Taylor Hand Function Test (JTHFT), Modified Frenchay Scale (MFS), Canadian Occupational Performance Measure (COPM), Goal Attainment Scale (GAS) and Stroke-Specific Quality of Life Scale (SSQOL) will be administered before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research Group | Experimental | Other: Occupational TherapyParticipants will be received Intensified sensory therapy. Other: Occupational Therapy Activities of Daily Living Training Intervention: Other: Occupational therapy intervention |
| Control Group | Experimental | Other: Occupational TherapyParticipants will be received Occupational Therapy. Other: Activities of Daily Living Training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stroke duration more than 6 months,
- To be able to communicate
- 10 degrees of wrist dorsiflexion starting from full palmar flexion of the wrist
- To initiate finger extension
Key exclusion criteria (7 listed)
- Joint contracture in the upper and lower extremities that will affect functionality other than stroke,
- Having a significant uncontrolled health problem and a history of epileptic seizures,
- Having 3 or more spasticity according to the Modified Ashworth Scale (MAS),
- Unable to communicate and cooperate,
- With marked ataxia and dystonia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational TherapyAlso: Activities of Daily Living Training, İntensified Sensory TherapyOccupational therapy is the only profession that helps people across the lifespan to do the things they want and need to do through the therapeutic use of daily activities (occupations). Occupational therapy practitioners enable people of all ages to live life to its fullest by helping them promote health, and prevent-or live better with-injury, illness, or disability. | Other | Control Group, Research Group |
Primary outcome
Canadian Occupational Performance Measure (COPM)- Satisfaction
Time frame: 3 weeks
Used to evaluate participants' self-perceived satisfaction with performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their satisfaction of how well they are able to complete each task on a scale of 1 (unsatisfied) to 10 (completely satisfied). Total scores are an mean of individual task scores and also range from 1 (unsatisfied) to 5 (completely satisfied). Collected data will be used to measure changes within and between groups on self-perceived satisfaction with performance between week 1 and 8, week 1 and 3.
Canadian Occupational Performance Measure (COPM)- Performance
Time frame: 3 weeks
Used to evaluate participants' self-perceived functional performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their perception of how well they are able to complete each task on a scale of 1 (unable to perform) to 10 (able to perform extremely well). Total scores are an mean of individual task scores and also range from 1 (unable to perform tasks) to 5 (able to perform tasks extremely well). Collected data will be used to measure changes within and between groups on self-perceived performance between week 1 and 3.
Jebsen Taylor Hand Function Test (JTHFT)
Time frame: 3 weeks
The JTHFT is a common and detailed clinical assessment for fine motor skills with weighted and non-weighted hand functions. The test is derived from activities of daily routine and consists of writing a standardized sentence, turning over 5 cards, picking up and replacing small objects; simulated eating using a spoon and 5 kidney beans, stacking 4 draughts pieces on a board, turning over 5 large empty tins and turning over 5 full tins.
The Modified Frenchay Scale (MFS)
Time frame: 3 weeks
The Modified Frenchay Scale (MFS) measures active upper limb function in hemiparesis based on a video review of 10 everyday living tasks, each rated on a 10-point visual analogic scale. Six tasks are bimanual and four are unimanual performed with the paretic hand. We will measured intra- and inter-rater reliability of MFS in hemiparetic patients among trained raters.
5 secondary outcomes
The Stroke Specific Quality Of Life Scale (SSQOL)
Time frame: 3 weeks
Sensory Test- Stereognosy Test
Time frame: 3 weeks
Sensory Test- Finger Shift Test
Time frame: 3 weeks
Sensory Test- Thumb Localization Test
Time frame: 3 weeks
Goal Attainment Scaling (GAS)
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Derived from this study: PubMed 41737162Yazici MR, Cekmece C. The efficacy of intensified sensory therapy on upper extremity functions and activities of daily living in patients with chronic stroke: A randomized controlled trial. Pak J Med Sci. 2026 Jan;42(1):161-167. doi: 10.12669/pjms.42.1.11940.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Çiğdem ÇEKMECE, PhD study chair
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy in people with Stroke and Sensory Defect, run by Kocaeli 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 4 inclusion and 7 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 21 Sep 2022. 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?
Canadian Occupational Performance Measure (COPM)- Satisfaction (time frame: 3 weeks). The study lists 4 primary outcomes in all. 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 NCT05133219, which also lists 1 linked publication.
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 21 Sep 2022.