Stroke PatientsNCT06701370
The Effect of Task-oriented Training on Upper Extremity Motor Functions in Chronic Stroke Patients
A study testing Task Oriented Training, Conventional Rehabilitation and Upper arm ergometer in people with Stroke Patients and Chronic Stroke Patients, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to investigate the effects of task-oriented training added to conventional rehabilitation on upper extremity muscle thickness and upper extremity motor functions. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke Patients, Chronic Stroke Patients
- What is being tested?
- Task Oriented Training, Conventional Rehabilitation and Upper arm ergometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2024to 30 Mar 2025
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of cerebrovascular accident at least 6 months ago;
- Score at least 20 points on the mini mental test;
- Not having pain with tension or severe weakness in the shoulder muscles;
- Active shoulder flexion movement of at least 30 degrees
- Having a stroke for the first time
- The level of motor function is Stage 3 or Stage 4 in Brunnstrom Staging according to the proximal function of the upper extremity
- Not receiving botulinum toxin treatment for the last 3 months
Who cannot join
- Presence of concomitant neurological, orthopedic, cardiovascular diseases and severe comorbidities
- Severe spasticity of the elbow flexors more than 2 on the Modified Ashworth Scale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Task-oriented Training With Conventional Rehabilitation on Upper Extremity Motor Functions in Chronic Stroke Patients
The aim of our study was to investigate the effects of task-oriented training added to conventional rehabilitation on upper extremity muscle thickness and upper extremity motor functions.
Read the detailed description
Stroke refers to a neurological disorder caused by cerebrovascular damage. It is defined as a sudden brain attack that causes partial or complete brain dysfunction due to blockage or rupture of blood vessels of the brain.The primary symptom of stroke is hemiparesis. In addition, stroke negatively affects senses, motor function, perception, cognition and language, depending on location, etiology and infarct volume. One study reported that %85 of stroke patients had hemiparesis and more than %69 had upper limp disfunction. In general, upper limb dysfunction not only causes problem in performing tasks that require fine motor skills (Daily tasks such as personal hygiene activities, eating and handwriting), but also makes ıt very difficult the perform tasks that require gross motor skills (such as balancing).(walking and self protection reflexes). Upper limb dysfunction reduces the quality of life (QoL) of patients with paralysis. It limits their ability to live independently in society as it impairs many of the basic IADLs (such as crawling, balancing, walking, writing, eating, washing and manipulating objects) necessary for individuals to live independently. Hands and arms are used in a wide range of tasks performed in the workplace and used to communicate.They also play an important role in various cognitive activities and motor functions. In stroke patients, the recovery of upper limb function, which is necessary to independently perform IADLs, can be considered as critical as the recovery of walking. The aim of therapeutic training in rehabilitation is to help patients try to use the affected side and voluntarily perform motor functions, and there are various physical intervention approaches.According to several recent studies conducted in stroke patients, among them, task-oriented training is reported to be effective in developing functional motor skills necessary to perform activities of daily living. Task-oriented training can help patients to increase their ability to perform IADLs. Training consists of a variety of functional activities that offer a more effective treatment approach. Task-oriented training is a therapeutic model based on the theory of motor control system, which regulates the movements of organisms by the nervous system, including reflexes. It uses a functional approach in the rehabilitation of neurological patients and teaches patients task-specific strategies to help them adapt to changing environments. The approach involves patients practicing a skill necessary to achieve the goal of a task to facilitate problem solving by improving their ability to adapt to various situations and developing an effective reward strategy. In addition, the approach for maximal learning involves motivating patients behaviorally using tasks related to their personal daily lives and emphasizes the interaction between patients and their environment. Task-focused training uses a patient-centered approach rather than a therapist-centered approach, and meaningful tasks are selected as a core component. The therapeutic goal of task-focused training is maximal recovery of motor function through proactive performance of activities using the upper limb on the affected side rather than the intact side . It was stated that repetitive and focused task-oriented training improves recovery of upper limb function and can improve motor order, dexterity and agility in the upper limb.
Lee also reported that task-oriented circuit training improved upper limb functions, performance in activities of daily living, and self-efficacy in expressing confidence.
The aim of our study was to investigate the effects of task-oriented training added to conventional rehabilitation on upper extremity muscle thickness and upper extremity motor functions.
- Conditions
- Stroke Patients, Chronic Stroke Patients
- Being tested
- Task Oriented Training, Conventional Rehabilitation, Upper arm ergometer
- Keywords
- task oriented training, stroke, exercise, upper extremity
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task Oriented TrainingOther
Task oriented training consists of opening the bottlecap, stacking cubes on different sizes, buttoning,screwing, wearing a coat.
Conventional RehabilitationOther
Bobath weightbearing and mobility exercises for upper extremity and 15 minutes Neuromuscular Electrical Stimulation.
Upper arm ergometerOther
The patients will be rode 5 minutes forwardly and 5 minutes backwardly
| Study group | Role | What they receive |
|---|---|---|
| Task oriented Training Group | Experimental | Conventional rehabilitation + Upper arm Ergometer
+ Task oriented Training Receives: Other: Task Oriented Training; Other: Conventional Rehabilitation; Other: Upper arm ergometer |
| Conventional Rehabilitation Group | Active comparator | Conventional rehabilitation + Upper arm Ergometer Receives: Other: Conventional Rehabilitation; Other: Upper arm ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Upper extremity assessment
It is a disease-specific, objective motor impairment scale designed especially for the evaluation of recovery in hemiplegic patients after stroke. It includes subsections evaluating joint movements, coordination and reflex activities related to the shoulder, elbow, forearm, wrist and hand. The highest score that can be obtained from this assessment is 66. The assessment is applied to the affected upper extremities of individuals in the sitting position. The evaluated joint movements are scored as 0: no movement, 1: partial movement and 2: normal movement. Reflex activity is assessed using a reflex hammer and scored as 0: no reflex activity, 2: reflex activity can be elicited.
Measured: 5 minutes
Wolf Motor Function Scale
It is an assessment method developed to evaluate motor skills and used in patients with moderate to severe upper extremity motor deficits. The original version was developed by Wolf et al. The modified version was used in our study and the validity and internal consistency of the WMFT have been proven. The test includes 17 activities. For 15 of the 17 activities, data are collected in two areas: "Functional Skill" and 'Performance Time". The other 2 activities evaluating muscle strength were not used in our study. The duration of the test is 30-45 minutes. Each activity was scored by the physiotherapist on a 0-5 point scale (0= Never used the affected hand during the activity, 5= Normal movement) using the "Functional skill scale". An average score should be calculated for the functional skills scale. Accordingly, the patient can score between 0-5 points in this evaluation and a high score indicates good functional skills. "Performance Time" is recorded in seconds. The
Measured: 5 minutes
Examination of muscle thickness by ultrasound
Muscle thickness of the biceps, triceps and anterior deltoid muscles on the hemiplegic and intact side will be measured and recorded by ultrosound before and after treatment.
Measured: 10 minutes
Secondary outcomes (4)
Motor Activity Log-28
MAG-28 is a structured assessment designed to examine how often and how well the person uses the affected arm outside the treatment session. The reason for choosing the 28-activity form of MAG, which can be found in many forms in the literature such as MAG-14 and MAG-30, in our study is that its validity and reliability have been proven. MAG-28 consists of two scales that question how often the patient uses the upper extremity of the affected side for each activity (Frequency of Use Scale) and how well the patient can perform the activity (Movement Quality Scale) during 28 daily activities (turning on a light switch, opening a door, etc.). The scales are printed on separate sheets of paper and remain in front of the patient being assessed throughout the administration of the test.
Measured: 5 minutes
2 minutes walking test
The test protocol will follow the guidelines recommended by Pin (24). The 2-minute walk test is repeated 2 times with a 10-minute rest between each trial to minimize fatigue in individuals. Each individual sits in a chair for 10 minutes before the 2-minute walk test. Each individual is asked to walk at their own pace without running for 2 minutes on a quiet, 10 m long concrete walkway. The start and end points of the walkway are clearly marked with brightly colored marker tape. Individuals are allowed to rest or stop at any time during the 2 minutes if necessary.
Measured: 5 minutes
Grip strength
Hand grip strength of the patients will be measured with Jamar Hand Dynamometer. The Jamar Hand Dynamometer has 5 different handles that can be adapted according to the patient's hand size . For the measurement, the patients are seated and the elbow is flexed ninety degrees, the forearm is in neutral position and the wrist is in extension between zero and thirty degrees. Measurements were taken for both sides and three measurements were taken at thirty-sixty second intervals and the average of the three measurements was recorded.
Measured: 3 minutes
Functional Independence Measurements
Defined as a comprehensive scale, the FIM assesses the functions of the individual in two main areas evaluates:
- Physical/motor functions (13 items)
- Cognitive functions (5 items) The items are a seven-level scale assessing different activities such as self-care, sphincter control, transfer, locomotion, communication and social perception. Level 1: Complete Dependence, Level 7: Complete Independence. The FIM total score is obtained by summing the scores of the 18 items. The maximum score can be 126 and the minimum score can be 18. A high total score indicates that the individual's dependence in Activities of Daily Living (ADL) decreases . Functional Independence Scale is presented in Appendix-8. All items should be evaluated and not left blank. Items are evaluated by sticking to the activities defined. For example, when questioning sphincter control, going to the toilet or sitting on the toilet is not taken into consideration.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start30 Oct 2024
- Primary completion15 Dec 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stroke PatientsStudies 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
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guzin Kaya Aytutuldu, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701370
- Sponsor's protocol ID
- BiruniUnive.
- Status last verified
- Sep 2025
- First submitted
- 20 Nov 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We share it in order to contribute to future studies.
Publications
Chang JJ, Tung WL, Wu WL, Su FC. Effect of bilateral reaching on affected arm motor control in stroke--with and without loading on unaffected arm. Disabil Rehabil. 2006 Dec 30;28(24):1507-16. doi: 10.1080/09638280600646060.
PubMed 17178614Yoo DH, Kim SY. Effects of upper limb robot-assisted therapy in the rehabilitation of stroke patients. J Phys Ther Sci. 2015 Mar;27(3):677-9. doi: 10.1589/jpts.27.677. Epub 2015 Mar 31.
PubMed 25931706Michaelsen SM, Dannenbaum R, Levin MF. Task-specific training with trunk restraint on arm recovery in stroke: randomized control trial. Stroke. 2006 Jan;37(1):186-92. doi: 10.1161/01.STR.0000196940.20446.c9. Epub 2005 Dec 8.
PubMed 16339469
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Task-oriented Training With Conventional Rehabilitation on Upper Extremity Motor Functions in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT06701370
- Acronym / sponsor ID
- BiruniUnive.
- Conditions
- Stroke Patients, Chronic Stroke Patients
- Keywords
- task oriented training, stroke, exercise, upper extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 22 Nov 2024 (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.
The aim of our study was to investigate the effects of task-oriented training added to conventional rehabilitation on upper extremity muscle thickness and upper extremity motor functions.
Detailed description
Stroke refers to a neurological disorder caused by cerebrovascular damage. It is defined as a sudden brain attack that causes partial or complete brain dysfunction due to blockage or rupture of blood vessels of the brain.The primary symptom of stroke is hemiparesis. In addition, stroke negatively affects senses, motor function, perception, cognition and language, depending on location, etiology and infarct volume. One study reported that %85 of stroke patients had hemiparesis and more than %69 had upper limp disfunction. In general, upper limb dysfunction not only causes problem in performing tasks that require fine motor skills (Daily tasks such as personal hygiene activities, eating and handwriting), but also makes ıt very difficult the perform tasks that require gross motor skills (such as balancing).(walking and self protection reflexes). Upper limb dysfunction reduces the quality of life (QoL) of patients with paralysis. It limits their ability to live independently in society as it impairs many of the basic IADLs (such as crawling, balancing, walking, writing, eating, washing and manipulating objects) necessary for individuals to live independently. Hands and arms are used in a wide range of tasks performed in the workplace and used to communicate.They also play an important role in various cognitive activities and motor functions. In stroke patients, the recovery of upper limb function, which is necessary to independently perform IADLs, can be considered as critical as the recovery of walking. The aim of therapeutic training in rehabilitation is to help patients try to use the affected side and voluntarily perform motor functions, and there are various physical intervention approaches.According to several recent studies conducted in stroke patients, among them, task-oriented training is reported to be effective in developing functional motor skills necessary to perform activities of daily living. Task-oriented training can help patients to increase their ability to perform IADLs. Training consists of a variety of functional activities that offer a more effective treatment approach. Task-oriented training is a therapeutic model based on the theory of motor control system, which regulates the movements of organisms by the nervous system, including reflexes. It uses a functional approach in the rehabilitation of neurological patients and teaches patients task-specific strategies to help them adapt to changing environments. The approach involves patients practicing a skill necessary to achieve the goal of a task to facilitate problem solving by improving their ability to adapt to various situations and developing an effective reward strategy. In addition, the approach for maximal learning involves motivating patients behaviorally using tasks related to their personal daily lives and emphasizes the interaction between patients and their environment. Task-focused training uses a patient-centered approach rather than a therapist-centered approach, and meaningful tasks are selected as a core component. The therapeutic goal of task-focused training is maximal recovery of motor function through proactive performance of activities using the upper limb on the affected side rather than the intact side . It was stated that repetitive and focused task-oriented training improves recovery of upper limb function and can improve motor order, dexterity and agility in the upper limb.
Lee also reported that task-oriented circuit training improved upper limb functions, performance in activities of daily living, and self-efficacy in expressing confidence.
The aim of our study was to investigate the effects of task-oriented training added to conventional rehabilitation on upper extremity muscle thickness and upper extremity motor functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task oriented Training Group | Experimental | Other: Task Oriented Training, Other: Conventional Rehabilitation, Other: Upper arm ergometerConventional rehabilitation + Upper arm Ergometer + Task oriented Training |
| Conventional Rehabilitation Group | Active comparator | Other: Conventional Rehabilitation, Other: Upper arm ergometerConventional rehabilitation + Upper arm Ergometer |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- History of cerebrovascular accident at least 6 months ago;
- Score at least 20 points on the mini mental test;
- Not having pain with tension or severe weakness in the shoulder muscles;
- Active shoulder flexion movement of at least 30 degrees
- Having a stroke for the first time
Key exclusion criteria (2 listed)
- Presence of concomitant neurological, orthopedic, cardiovascular diseases and severe comorbidities
- Severe spasticity of the elbow flexors more than 2 on the Modified Ashworth Scale
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 |
|---|---|---|
| Task Oriented TrainingTask oriented training consists of opening the bottlecap, stacking cubes on different sizes, buttoning,screwing, wearing a coat. | Other | Task oriented Training Group |
| Conventional RehabilitationBobath weightbearing and mobility exercises for upper extremity and 15 minutes Neuromuscular Electrical Stimulation. | Other | Conventional Rehabilitation Group, Task oriented Training Group |
| Upper arm ergometerThe patients will be rode 5 minutes forwardly and 5 minutes backwardly | Other | Conventional Rehabilitation Group, Task oriented Training Group |
Primary outcome
Fugl Meyer Upper extremity assessment
Time frame: 5 minutes
It is a disease-specific, objective motor impairment scale designed especially for the evaluation of recovery in hemiplegic patients after stroke. It includes subsections evaluating joint movements, coordination and reflex activities related to the shoulder, elbow, forearm, wrist and hand. The highest score that can be obtained from this assessment is 66. The assessment is applied to the affected upper extremities of individuals in the sitting position. The evaluated joint movements are scored as 0: no movement, 1: partial movement and 2: normal movement. Reflex activity is assessed using a reflex hammer and scored as 0: no reflex activity, 2: reflex activity can be elicited.
Wolf Motor Function Scale
Time frame: 5 minutes
It is an assessment method developed to evaluate motor skills and used in patients with moderate to severe upper extremity motor deficits. The original version was developed by Wolf et al. The modified version was used in our study and the validity and internal consistency of the WMFT have been proven. The test includes 17 activities. For 15 of the 17 activities, data are collected in two areas: "Functional Skill" and 'Performance Time". The other 2 activities evaluating muscle strength were not used in our study. The duration of the test is 30-45 minutes. Each activity was scored by the physiotherapist on a 0-5 point scale (0= Never used the affected hand during the activity, 5= Normal movement) using the "Functional skill scale". An average score should be calculated for the functional skills scale. Accordingly, the patient can score between 0-5 points in this evaluation and a high score indicates good functional skills. "Performance Time" is recorded in seconds. The
Examination of muscle thickness by ultrasound
Time frame: 10 minutes
Muscle thickness of the biceps, triceps and anterior deltoid muscles on the hemiplegic and intact side will be measured and recorded by ultrosound before and after treatment.
4 secondary outcomes
Motor Activity Log-28
Time frame: 5 minutes
2 minutes walking test
Time frame: 5 minutes
Grip strength
Time frame: 3 minutes
Functional Independence Measurements
Time frame: 10 minutes
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 17 Sep 2025.
- Results publication: PubMed 17178614Chang JJ, Tung WL, Wu WL, Su FC. Effect of bilateral reaching on affected arm motor control in stroke--with and without loading on unaffected arm. Disabil Rehabil. 2006 Dec 30;28(24):1507-16. doi: 10.1080/09638280600646060.
- Results publication: PubMed 25931706Yoo DH, Kim SY. Effects of upper limb robot-assisted therapy in the rehabilitation of stroke patients. J Phys Ther Sci. 2015 Mar;27(3):677-9. doi: 10.1589/jpts.27.677. Epub 2015 Mar 31.
- Results publication: PubMed 16339469Michaelsen SM, Dannenbaum R, Levin MF. Task-specific training with trunk restraint on arm recovery in stroke: randomized control trial. Stroke. 2006 Jan;37(1):186-92. doi: 10.1161/01.STR.0000196940.20446.c9. Epub 2005 Dec 8.
- Individual participant dataSharing planned: Yes. We share it in order to contribute to future studies.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task Oriented Training, Conventional Rehabilitation and Upper arm ergometer in people with Stroke Patients and Chronic Stroke Patients, run by Biruni 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 7 inclusion and 2 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 17 Sep 2025. 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?
Fugl Meyer Upper extremity assessment (time frame: 5 minutes). The study lists 3 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 NCT06701370, which also lists 3 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 17 Sep 2025.