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Effect of mCIMT on Upper Extremity Functions of Stroke Patients With Right/Left Hemiplegia

Primary Purpose

Stroke Patients

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Modified Constraint Induced Movement Therapy
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Istanbul University Istanbul Medicine FacultyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

left hemiplegia

right hemiplegia

control

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
Box-Block Test
Box-Block Test
Box-Block Test
Box-Block Test
Box-Block Test
Box-Block Test
exercise assessment parameters-cubes lined
cubes lined in 30 seconds
exercise assessment parameters-cubes lined
cubes lined in 30 seconds
exercise assessment parameters-cubes lined
cubes lined in 30 seconds
exercise assessment parameters-card turned
card turned in 30 seconds
exercise assessment parameters-card turned
card turned in 30 seconds
exercise assessment parameters-card turned
card turned in 30 seconds
exercise assessment parameters-object gripped
object gripped in 30 seconds
exercise assessment parameters-object gripped
object gripped in 30 seconds
exercise assessment parameters-object gripped
object gripped in 30 seconds
exercise assessment parameters-water
time it takes to grip and carry a water filled glass to their mouth and putting it back
exercise assessment parameters-water
time it takes to grip and carry a water filled glass to their mouth and putting it back
exercise assessment parameters-water
time it takes to grip and carry a water filled glass to their mouth and putting it back

Secondary Outcome Measures

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)
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)
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)

Full Information

First Posted
April 12, 2019
Last Updated
July 8, 2019
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04013750
Brief Title
Effect of mCIMT on Upper Extremity Functions of Stroke Patients With Right/Left Hemiplegia
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
November 21, 2019 (Anticipated)
Study Completion Date
November 21, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
left hemiplegia
Arm Type
Experimental
Arm Description
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
Arm Title
right hemiplegia
Arm Type
Experimental
Arm Description
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
Arm Title
control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Modified Constraint Induced Movement Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Motor Activity Log
Description
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.
Time Frame
Patients were examined at baseline
Title
Motor Activity Log
Description
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.
Time Frame
Patients were examined 2 weeks after baseline
Title
Motor Activity Log
Description
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.
Time Frame
Patients were examined 3 months after baseline
Title
Fugl-Meyer Motor Assessment Scale
Description
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.
Time Frame
Patients were examined at baseline
Title
Fugl-Meyer Motor Assessment Scale
Description
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.
Time Frame
Patients were examined 2 weeks after baseline
Title
Fugl-Meyer Motor Assessment Scale
Description
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.
Time Frame
Patients were examined 3 months after baseline
Title
Box-Block Test
Description
Box-Block Test
Time Frame
Patients were examined at baseline
Title
Box-Block Test
Description
Box-Block Test
Time Frame
Patients were examined 2 weeks after baseline
Title
Box-Block Test
Description
Box-Block Test
Time Frame
Patients were examined 3 months after baseline
Title
exercise assessment parameters-cubes lined
Description
cubes lined in 30 seconds
Time Frame
Patients were examined at baseline
Title
exercise assessment parameters-cubes lined
Description
cubes lined in 30 seconds
Time Frame
Patients were examined 2 weeks after baseline
Title
exercise assessment parameters-cubes lined
Description
cubes lined in 30 seconds
Time Frame
Patients were examined 3 months after baseline
Title
exercise assessment parameters-card turned
Description
card turned in 30 seconds
Time Frame
Patients were examined at baseline
Title
exercise assessment parameters-card turned
Description
card turned in 30 seconds
Time Frame
Patients were examined 2 weeks after baseline
Title
exercise assessment parameters-card turned
Description
card turned in 30 seconds
Time Frame
Patients were examined 3 months after baseline
Title
exercise assessment parameters-object gripped
Description
object gripped in 30 seconds
Time Frame
Patients were examined at baseline
Title
exercise assessment parameters-object gripped
Description
object gripped in 30 seconds
Time Frame
Patients were examined 2 weeks after baseline
Title
exercise assessment parameters-object gripped
Description
object gripped in 30 seconds
Time Frame
Patients were examined 3 months after baseline
Title
exercise assessment parameters-water
Description
time it takes to grip and carry a water filled glass to their mouth and putting it back
Time Frame
Patients were examined at baseline
Title
exercise assessment parameters-water
Description
time it takes to grip and carry a water filled glass to their mouth and putting it back
Time Frame
Patients were examined 2 weeks after baseline
Title
exercise assessment parameters-water
Description
time it takes to grip and carry a water filled glass to their mouth and putting it back
Time Frame
Patients were examined 3 months after baseline
Secondary Outcome Measure Information:
Title
Stroke Impact Scale
Description
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)
Time Frame
Patients were examined at baseline
Title
Stroke Impact Scale
Description
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)
Time Frame
Patients were examined 2 weeks after baseline
Title
Stroke Impact Scale
Description
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)
Time Frame
Patients were examined 3 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
cansın medin ceylan, asistant
Phone
531-575-9539
Email
cansinmedin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ayşe yalıman, professor
Phone
531-575-9539
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ayşe yalıman, professor
Organizational Affiliation
istanbul university physical medicine and rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University Istanbul Medicine Faculty
City
Istanbul
State/Province
Physical Medicine And Rehabilitation
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ayşe yalıman, profesor

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28050492
Citation
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.
Results Reference
result

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Effect of mCIMT on Upper Extremity Functions of Stroke Patients With Right/Left Hemiplegia

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