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

NCT04013750 | Unknown

• 1 other identifier: 415687
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Patients

Outcome Measures

Primary Outcomes (21)

• 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 Outcomes (3)

• Stroke Impact Scale

  Patients were examined at baseline

• Stroke Impact Scale

  Patients were examined 2 weeks after baseline

• Stroke Impact Scale

  Patients were examined 3 months after baseline

Study Arms (3)

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

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

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.

Interventions

Modified Constraint Induced Movement Therapy OTHER

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.

left hemiplegia; right hemiplegia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Medicine Faculty

Istanbul, Physical Medicine and Rehabilitation, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 28050492 RESULT

Study Officials

• ayşe yalıman, professor

  istanbul university physical medicine and rehabilitation

  STUDY DIRECTOR

Central Study Contacts

cansın medin ceylan, asistant

CONTACT

531-575-9539; cansinmedin@hotmail.com

ayşe yalıman, professor

CONTACT

531-575-9539

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant doctor

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: July 10, 2019
• Study Start: January 2, 2018
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)