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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

cansın medin ceylan, asistant contact

531-575-9539

cansinmedin@hotmail.com

ayşe yalıman, professor contact

531-575-9539

Turkey (Türkiye)1 site, 1 recruiting
  • Istanbul University Istanbul Medicine Faculty

    Istanbul, Physical Medicine and Rehabilitation

    ayşe yalıman, profesor

    Recruiting

Other trials in Turkey (Türkiye)

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 groups in NCT04013750
Study groupRoleWhat they receive
left hemiplegiaExperimentalPatients 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 hemiplegiaExperimentalPatients 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
controlNo intervention10 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Box-Block Test

    Box-Block Test

    Measured: Patients were examined at baseline

  8. Box-Block Test

    Box-Block Test

    Measured: Patients were examined 2 weeks after baseline

  9. Box-Block Test

    Box-Block Test

    Measured: Patients were examined 3 months after baseline

  10. exercise assessment parameters-cubes lined

    cubes lined in 30 seconds

    Measured: Patients were examined at baseline

  11. exercise assessment parameters-cubes lined

    cubes lined in 30 seconds

    Measured: Patients were examined 2 weeks after baseline

  12. exercise assessment parameters-cubes lined

    cubes lined in 30 seconds

    Measured: Patients were examined 3 months after baseline

  13. exercise assessment parameters-card turned

    card turned in 30 seconds

    Measured: Patients were examined at baseline

  14. exercise assessment parameters-card turned

    card turned in 30 seconds

    Measured: Patients were examined 2 weeks after baseline

  15. exercise assessment parameters-card turned

    card turned in 30 seconds

    Measured: Patients were examined 3 months after baseline

  16. exercise assessment parameters-object gripped

    object gripped in 30 seconds

    Measured: Patients were examined at baseline

  17. exercise assessment parameters-object gripped

    object gripped in 30 seconds

    Measured: Patients were examined 2 weeks after baseline

  18. exercise assessment parameters-object gripped

    object gripped in 30 seconds

    Measured: Patients were examined 3 months after baseline

  19. 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

  20. 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

  21. 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)
  1. 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

  2. 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

  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 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.

  1. First posted10 Jul 2019
  2. Study start2 Jan 2018
  3. Primary completion21 Nov 2019 (estimated)
  4. Study completion21 Nov 2019 (estimated)

Resources

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)
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

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.

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