Stroke PatientsNCT04013750
Effect of mCIMT on Upper Extremity Functions of Stroke Patients With Right/Left Hemiplegia
A study testing Modified Constraint Induced Movement Therapy in people with Stroke Patients, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed To analyze effect of modified constraint induced movement therapy on upper extremity functions and quality of life of subacute and chronic phase stroke patients with right/left hemisphere damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Patients
- What is being tested?
- Modified Constraint Induced Movement Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2018to 21 Nov 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in subacute and chronic period (3 months after stroke)
- Modified Ashworth scale in the hemiplegic arm with 3 or more spasticity
- No pain in the hemiplegic arm
- MMSE 20 and above
- Without major medical problems
- No previous stroke history
- Adequate stability to walk when healthy arm is immobilized
- Active 20 degrees wrist extension and 10 degrees interphalangeal and metacarpophalangeal extension (these movements should be repeated 3 times in 1 minute)
Who cannot join
- Bilateral stroke or brainstem affected
- Active 20-degree wrist extension and 10-degree interphalangeal and metacarpophalangeal extension
- Global aphasia or cognitive disorders that may affect understanding of test instructions
- Patients with major medical problems that may affect participation
- Existence of neglect
Trial locations and contacts
1 site in 1 country.
ayşe yalıman, professor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Istanbul Medicine Faculty
Istanbul, Physical Medicine and Rehabilitation
ayşe yalıman, profesor
About this study
Official title: Effect of Modified Constraint Induced Movement Therapy on Upper Extremity Functions of Stroke Patients With Right/Left Hemisphere Damage: Single Blind Randomized Controlled Trial
The investigators aimed To analyze effect of modified constraint induced movement therapy on upper extremity functions and quality of life of subacute and chronic phase stroke patients with right/left hemisphere damage. A total of 40 patients (20 patients with right hemiplegia and 20 patients with left hemiplegia) were enrolled in our prospective, randomized and controlled trial. Patients were randomized in to three groups. The first group consists of 10 right hemiplegia patients and the second group consists of 10 left hemiplegia patients. First and second group of patients had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake. Patients were examined before treatment, just after treatment and 3 months after treatment using Box-Block Test, cubes lined, card turned and object gripped in 30 seconds, time it takes to grip and carry a water filled glass to their mouth and putting it back, Motor Activity Log (MAL), Stroke Impact Scale, Fugl-Meyer Motor Assessment Scale.
Read the detailed description
For the rehabilitation of the paretic upper extremity, the use of constraint induced movement therapy and the use of modified constraint induced movement therapy are the most effective treatment strategies. The investigators aimed To analyze effect of modified constraint induced movement therapy on upper extremity functions and quality of life of subacute and chronic phase stroke patients with right/left hemisphere damage.
A total of 40 patients (20 patients with right hemiplegia and 20 patients with left hemiplegia) were enrolled in our prospective, randomized and controlled trial. Patients were randomized in to three groups. The first group consists of 10 right hemiplegia patients and the second group consists of 10 left hemiplegia patients. First and second group of patients had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake. 10 patients with right hemiplegia and 10 patients with left hemiplegia formed the control group and these patients were in line for inpatient rehabilitation programme. Patients were examined before treatment, just after treatment and 3 months after treatment using Box-Block Test, cubes lined, card turned and object gripped in 30 seconds, time it takes to grip and carry a water filled glass to their mouth and putting it back, Motor Activity Log (MAL), Stroke Impact Scale, Fugl-Meyer Motor Assessment Scale. Wilcoxon Signed Ranks test and Friedman test were used for intragroup comparison of data and Kruskal-Wallis test was used to compare data between groups.
- Conditions
- Stroke Patients
- Being tested
- Modified Constraint Induced Movement Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Constraint Induced Movement TherapyOther
constraint-induced movement therapy (CIMT) is characterized by the restraint of the less effected upper limb accompanied by the shaping and repetitive task-oriented training of more affected upper extremity.
| Study group | Role | What they receive |
|---|---|---|
| left hemiplegia | Experimental | Patients in the left hemiplegia group had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake Receives: Other: Modified Constraint Induced Movement Therapy |
| right hemiplegia | Experimental | Patients in the right hemiplegia group had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake Receives: Other: Modified Constraint Induced Movement Therapy |
| control | No intervention | 10 patients with right hemiplegia and 10 patients with left hemiplegia formed the control group and these patients were in line for inpatient rehabilitation programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Activity Log
Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.
Measured: Patients were examined at baseline
Motor Activity Log
Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.
Measured: Patients were examined 2 weeks after baseline
Motor Activity Log
Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.
Measured: Patients were examined 3 months after baseline
Fugl-Meyer Motor Assessment Scale
The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity.
Measured: Patients were examined at baseline
Fugl-Meyer Motor Assessment Scale
The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity.
Measured: Patients were examined 2 weeks after baseline
Fugl-Meyer Motor Assessment Scale
The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity.
Measured: Patients were examined 3 months after baseline
Box-Block Test
Box-Block Test
Measured: Patients were examined at baseline
Box-Block Test
Box-Block Test
Measured: Patients were examined 2 weeks after baseline
Box-Block Test
Box-Block Test
Measured: Patients were examined 3 months after baseline
exercise assessment parameters-cubes lined
cubes lined in 30 seconds
Measured: Patients were examined at baseline
exercise assessment parameters-cubes lined
cubes lined in 30 seconds
Measured: Patients were examined 2 weeks after baseline
exercise assessment parameters-cubes lined
cubes lined in 30 seconds
Measured: Patients were examined 3 months after baseline
exercise assessment parameters-card turned
card turned in 30 seconds
Measured: Patients were examined at baseline
exercise assessment parameters-card turned
card turned in 30 seconds
Measured: Patients were examined 2 weeks after baseline
exercise assessment parameters-card turned
card turned in 30 seconds
Measured: Patients were examined 3 months after baseline
exercise assessment parameters-object gripped
object gripped in 30 seconds
Measured: Patients were examined at baseline
exercise assessment parameters-object gripped
object gripped in 30 seconds
Measured: Patients were examined 2 weeks after baseline
exercise assessment parameters-object gripped
object gripped in 30 seconds
Measured: Patients were examined 3 months after baseline
exercise assessment parameters-water
time it takes to grip and carry a water filled glass to their mouth and putting it back
Measured: Patients were examined at baseline
exercise assessment parameters-water
time it takes to grip and carry a water filled glass to their mouth and putting it back
Measured: Patients were examined 2 weeks after baseline
exercise assessment parameters-water
time it takes to grip and carry a water filled glass to their mouth and putting it back
Measured: Patients were examined 3 months after baseline
Secondary outcomes (3)
Stroke Impact Scale
Stroke Impact Scale 3,0; The aim of the study is to evaluate the perception of the quality of life after stroke by the patients themselves or their caregivers. It is a stroke-specific, patient-centered quality of life measure. It consists of 8 subsections and 59 questions. Each question is scored by evaluating the difficulty experienced in the last week on a 5-point scale. It also includes the assessment of post-stroke recovery perception with a visual analog scale of 0-100 points (0: no improvement, 100: complete recovery)
Measured: Patients were examined at baseline
Stroke Impact Scale
Stroke Impact Scale 3,0; The aim of the study is to evaluate the perception of the quality of life after stroke by the patients themselves or their caregivers. It is a stroke-specific, patient-centered quality of life measure. It consists of 8 subsections and 59 questions. Each question is scored by evaluating the difficulty experienced in the last week on a 5-point scale. It also includes the assessment of post-stroke recovery perception with a visual analog scale of 0-100 points (0: no improvement, 100: complete recovery)
Measured: Patients were examined 2 weeks after baseline
Stroke Impact Scale
Stroke Impact Scale 3,0; The aim of the study is to evaluate the perception of the quality of life after stroke by the patients themselves or their caregivers. It is a stroke-specific, patient-centered quality of life measure. It consists of 8 subsections and 59 questions. Each question is scored by evaluating the difficulty experienced in the last week on a 5-point scale. It also includes the assessment of post-stroke recovery perception with a visual analog scale of 0-100 points (0: no improvement, 100: complete recovery)
Measured: Patients were examined 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start2 Jan 2018
- Primary completion21 Nov 2019 (estimated)
- Study completion21 Nov 2019 (estimated)
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 Stroke PatientsStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansin Medin Ceylan, Istanbul University
- Investigators
- ayşe yalıman, professor, Study director, istanbul university physical medicine and rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013750
- Sponsor's protocol ID
- 415687
- Status last verified
- Jul 2019
- First submitted
- 12 Apr 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yadav RK, Sharma R, Borah D, Kothari SY. Efficacy of Modified Constraint Induced Movement Therapy in the Treatment of Hemiparetic Upper Limb in Stroke Patients: A Randomized Controlled Trial. J Clin Diagn Res. 2016 Nov;10(11):YC01-YC05. doi: 10.7860/JCDR/2016/23468.8899. Epub 2016 Nov 1.
PubMed 28050492
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Constraint Induced Movement Therapy on Upper Extremity Functions of Stroke Patients With Right/Left Hemisphere Damage: Single Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04013750
- Acronym / sponsor ID
- 415687
- Conditions
- Stroke Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 21 Nov 2019 (estimated)
- Study completion
- 21 Nov 2019 (estimated)
- First posted
- 10 Jul 2019 (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 investigators aimed To analyze effect of modified constraint induced movement therapy on upper extremity functions and quality of life of subacute and chronic phase stroke patients with right/left hemisphere damage. A total of 40 patients (20 patients with right hemiplegia and 20 patients with left hemiplegia) were enrolled in our prospective, randomized and controlled trial. Patients were randomized in to three groups. The first group consists of 10 right hemiplegia patients and the second group consists of 10 left hemiplegia patients. First and second group of patients had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake. Patients were examined before treatment, just after treatment and 3 months after treatment using Box-Block Test, cubes lined, card turned and object gripped in 30 seconds, time it takes to grip and carry a water filled glass to their mouth and putting it back, Motor Activity Log (MAL), Stroke Impact Scale, Fugl-Meyer Motor Assessment Scale.
Detailed description
For the rehabilitation of the paretic upper extremity, the use of constraint induced movement therapy and the use of modified constraint induced movement therapy are the most effective treatment strategies. The investigators aimed To analyze effect of modified constraint induced movement therapy on upper extremity functions and quality of life of subacute and chronic phase stroke patients with right/left hemisphere damage.
A total of 40 patients (20 patients with right hemiplegia and 20 patients with left hemiplegia) were enrolled in our prospective, randomized and controlled trial. Patients were randomized in to three groups. The first group consists of 10 right hemiplegia patients and the second group consists of 10 left hemiplegia patients. First and second group of patients had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake. 10 patients with right hemiplegia and 10 patients with left hemiplegia formed the control group and these patients were in line for inpatient rehabilitation programme. Patients were examined before treatment, just after treatment and 3 months after treatment using Box-Block Test, cubes lined, card turned and object gripped in 30 seconds, time it takes to grip and carry a water filled glass to their mouth and putting it back, Motor Activity Log (MAL), Stroke Impact Scale, Fugl-Meyer Motor Assessment Scale. Wilcoxon Signed Ranks test and Friedman test were used for intragroup comparison of data and Kruskal-Wallis test was used to compare data between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| left hemiplegia | Experimental | Other: Modified Constraint Induced Movement TherapyPatients in the left hemiplegia group had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake |
| right hemiplegia | Experimental | Other: Modified Constraint Induced Movement TherapyPatients in the right hemiplegia group had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake |
| control | No intervention | –10 patients with right hemiplegia and 10 patients with left hemiplegia formed the control group and these patients were in line for inpatient rehabilitation programme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients in subacute and chronic period (3 months after stroke)
- Modified Ashworth scale in the hemiplegic arm with 3 or more spasticity
- No pain in the hemiplegic arm
- MMSE 20 and above
- Without major medical problems
Key exclusion criteria (5 listed)
- Bilateral stroke or brainstem affected
- Active 20-degree wrist extension and 10-degree interphalangeal and metacarpophalangeal extension
- Global aphasia or cognitive disorders that may affect understanding of test instructions
- Patients with major medical problems that may affect participation
- Existence of neglect
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 |
|---|---|---|
| Modified Constraint Induced Movement Therapyconstraint-induced movement therapy (CIMT) is characterized by the restraint of the less effected upper limb accompanied by the shaping and repetitive task-oriented training of more affected upper extremity. | Other | left hemiplegia, right hemiplegia |
Primary outcome
Motor Activity Log
Time frame: Patients were examined at baseline
Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.
Motor Activity Log
Time frame: Patients were examined 2 weeks after baseline
Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.
Motor Activity Log
Time frame: Patients were examined 3 months after baseline
Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.
Fugl-Meyer Motor Assessment Scale
Time frame: Patients were examined at baseline
The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity.
Fugl-Meyer Motor Assessment Scale
Time frame: Patients were examined 2 weeks after baseline
The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity.
Fugl-Meyer Motor Assessment Scale
Time frame: Patients were examined 3 months after baseline
The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity.
Box-Block Test
Time frame: Patients were examined at baseline
Box-Block Test
Box-Block Test
Time frame: Patients were examined 2 weeks after baseline
Box-Block Test
Box-Block Test
Time frame: Patients were examined 3 months after baseline
Box-Block Test
exercise assessment parameters-cubes lined
Time frame: Patients were examined at baseline
cubes lined in 30 seconds
exercise assessment parameters-cubes lined
Time frame: Patients were examined 2 weeks after baseline
cubes lined in 30 seconds
exercise assessment parameters-cubes lined
Time frame: Patients were examined 3 months after baseline
cubes lined in 30 seconds
exercise assessment parameters-card turned
Time frame: Patients were examined at baseline
card turned in 30 seconds
exercise assessment parameters-card turned
Time frame: Patients were examined 2 weeks after baseline
card turned in 30 seconds
exercise assessment parameters-card turned
Time frame: Patients were examined 3 months after baseline
card turned in 30 seconds
exercise assessment parameters-object gripped
Time frame: Patients were examined at baseline
object gripped in 30 seconds
exercise assessment parameters-object gripped
Time frame: Patients were examined 2 weeks after baseline
object gripped in 30 seconds
exercise assessment parameters-object gripped
Time frame: Patients were examined 3 months after baseline
object gripped in 30 seconds
exercise assessment parameters-water
Time frame: Patients were examined at baseline
time it takes to grip and carry a water filled glass to their mouth and putting it back
exercise assessment parameters-water
Time frame: Patients were examined 2 weeks after baseline
time it takes to grip and carry a water filled glass to their mouth and putting it back
exercise assessment parameters-water
Time frame: Patients were examined 3 months after baseline
time it takes to grip and carry a water filled glass to their mouth and putting it back
3 secondary outcomes
Stroke Impact Scale
Time frame: Patients were examined at baseline
Stroke Impact Scale
Time frame: Patients were examined 2 weeks after baseline
Stroke Impact Scale
Time frame: Patients were examined 3 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Results publication: PubMed 28050492Yadav RK, Sharma R, Borah D, Kothari SY. Efficacy of Modified Constraint Induced Movement Therapy in the Treatment of Hemiparetic Upper Limb in Stroke Patients: A Randomized Controlled Trial. J Clin Diagn Res. 2016 Nov;10(11):YC01-YC05. doi: 10.7860/JCDR/2016/23468.8899. Epub 2016 Nov 1.
- Individual participant dataSharing planned: No
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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.
ayşe yalıman, professor contact
ayşe yalıman, professor study director
istanbul university physical medicine and rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Constraint Induced Movement Therapy in people with Stroke Patients, run by Istanbul 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact cansın medin ceylan, asistant (531-575-9539, cansinmedin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Activity Log (time frame: Patients were examined at baseline). The study lists 21 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 NCT04013750, 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 10 Jul 2019.