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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke Patients
• Intervention / Treatment: Other: Modified Constraint Induced Movement Therapy

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: cansın medin ceylan, asistant; Phone Number: 531-575-9539; Email: cansinmedin@hotmail.com
• Study Contact Backup: Name: ayşe yalıman, professor; Phone Number: 531-575-9539

Study Locations

• Turkey
  • Physical Medicine And Rehabilitation
    • Istanbul, Physical Medicine And Rehabilitation, Turkey
      • Recruiting
      • Istanbul University Istanbul Medicine Faculty
      • Contact: ayşe yalıman, profesor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: left hemiplegia; 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	Other: Modified Constraint Induced Movement Therapy; 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.
Experimental: right hemiplegia; 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	Other: Modified Constraint Induced Movement Therapy; 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.
No Intervention: control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Patients were examined 3 months after baseline
Box-Block Test	Box-Block Test	Patients were examined at baseline
Box-Block Test	Box-Block Test	Patients were examined 2 weeks after baseline
Box-Block Test	Box-Block Test	Patients were examined 3 months after baseline
exercise assessment parameters-cubes lined	cubes lined in 30 seconds	Patients were examined at baseline
exercise assessment parameters-cubes lined	cubes lined in 30 seconds	Patients were examined 2 weeks after baseline
exercise assessment parameters-cubes lined	cubes lined in 30 seconds	Patients were examined 3 months after baseline
exercise assessment parameters-card turned	card turned in 30 seconds	Patients were examined at baseline
exercise assessment parameters-card turned	card turned in 30 seconds	Patients were examined 2 weeks after baseline
exercise assessment parameters-card turned	card turned in 30 seconds	Patients were examined 3 months after baseline
exercise assessment parameters-object gripped	object gripped in 30 seconds	Patients were examined at baseline
exercise assessment parameters-object gripped	object gripped in 30 seconds	Patients were examined 2 weeks after baseline
exercise assessment parameters-object gripped	object gripped in 30 seconds	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	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	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	Patients were examined 3 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	Patients were examined 3 months after baseline

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Study Director: ayşe yalıman, professor, istanbul university physical medicine and rehabilitation

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Anticipated): November 21, 2019
• Study Completion (Anticipated): November 21, 2019

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 415687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No