Comparison of Constraint Induced Movement Therapy and Mirror Therapy

May 6, 2024 updated by: Riphah International University

Effects of CIMT With and Without Mirror Therapy on Upper Limb Function in Children With Hemiplegic Cerebral Palsy

Hemiplegia in infants and children is a type of Cerebral Palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. This damage may occur before, during or shortly after birth. The term hemiplegia means that the paralysis is on one vertical half of the body. The aim of this study will be the to know the effect of mCIMT with and without mirror therapy on upper limb function in children with hemiplegic cerebral palsy. A randomized control trial will be conducted at Sheikh Zayed Hospital, RYK through convenience sampling technique on 30 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with mCIMT and Group B will be treated with mCIMT and mirror therapy. Outcome measure will be conducted through pain and disability questionnaire after 6 weeks. Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. mCIMT with and without mirror therapy will be applied in patients with hemiplegic cerebral palsy to see the effect on upper limb function.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients who will meet the inclusion criteria will be recruited by convenience sampling technique and allocated to groups by simple randomization process by sealed opaque enveloped labeled as 0 for Group A and 1 for Group B.

After taking consent from the patients parents with hemiplegic CP of both genders will be randomized into two equal groups. Patients from physical therapy department will be assessed with CHEQ and Melbourne Assessment of the Unilateral Upper Limb Function (MAULF) and the Functional Hand Grip Test (FHGT) . At start of study, a formal educational session, lasting about 30 min will be given by physiotherapist.

Group A: This group patients will be treated with mCIMT, the forced use of the affected arm by restraining the unaffected arm, with a sling or a hand splint, during dedicated exercise sections or usual ADLs (90% of waking hours).Massed practice (eight hours of exercise) of the affected arm through a shaping method, where shaping involves a commonly operant conditioning method in which a behavioural objective (in this case 'movement') is approached in small steps of progressively increasing difficulty. The participant is rewarded with enthusiastic approval for improvement, but never blamed or punished for failure. This therapy will be given 4hrs daily for 6 weeks. The results will be based upon pre and post evaluation.

Group B: These patients will be treated with mCIMT and mirror therapy. Children were taught repetitive symmetrical upper limbs exercises: with modelling-clay in each hand to elicit bilateral thumb-finger pinch and grasping. They performed these during a 15-minute daily routine at home with mCIMT (forced use of arm and massed practice 4hrs of exercise of affected arm). This combination of therapy will be given for 6 weeks. The results will be seen through pre and post evaluation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Riphah International University
      • Lahore, Punjab, Pakistan, 54000
        • Imran Amjad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Medically diagnosed with Hemiplegic CP
  • Age ranges btween3-12 years
  • Hemiplegic CP with motor disability
  • No major contractures of upper limb muscle
  • Both genders were included
  • Able to follow command
  • No orthopedic surgery during the previous six months(8)

Exclusion Criteria:

  • Functional limb
  • Patients with contracture
  • Patient with sensory,cognitive and perceptual disorders
  • Patient with seizures
  • Patient with orthopedic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Constraint induced Movement Therapy
Group of 15 members will be given constraint induced movement therapy for 6 weeks.
Other: Constraint Induced Movement Therapy
Group A: This group patients will be treated with mCIMT, the forced use of the affected arm by restraining the unaffected arm, with a sling or a hand splint, during dedicated exercise sections or usual ADLs (90% of waking hours).Massed practice (eight hours of exercise) of the affected arm through a shaping method, where shaping involves a commonly operant conditioning method in which a behavioural objective (in this case 'movement') is approached in small steps of progressively increasing difficulty. The participant is rewarded with enthusiastic approval for improvement, but never blamed or punished for failure. This therapy will be given 4hrs daily for 6 weeks. The results will be based upon pre and post evaluation.
Other Names:
  • Mirror Therapy
Experimental: Mirror therapy group
Group of 15 members will be given modified constraint induced movement therapy with mirror theray for 6 weeks.
Other: Mirror therapy
Group B: These patients will be treated with mCIMT and mirror therapy. Children were taught repetitive symmetrical upper limbs exercises: with modelling-clay in each hand to elicit bilateral thumb-finger pinch and grasping. They performed these during a 15-minute daily routine at home with mCIMT (forced use of arm and massed practice 4hrs of exercise of affected arm). This combination of therapy will be given for 6 weeks. The results will be seen through pre and post evaluation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
fine motor skills
Time Frame: 6weeks

The Melbourne Assessment 2 (MA2): a test of quality of unilateral upper limb function. Is a criterion-referenced test for children aged 2.5 to 15 years with neurological impairments providing measurement of four elements of upper limb movement quality: range of movement, accuracy, dexterity and fluency.

FHGT: The subject holds the dynamometer in the hand to be tested, with the arm at right angles and the elbow by the side of the body. The handle of the dynamometer is adjusted if required - the base should rest on the first metacarpal (heel of palm), while the handle should rest on middle of the four fingers. When ready the subject squeezes the dynamometer with maximum isometric effort, which is maintained for about 5 seconds. No other body movement is allowed. The subject should be strongly encouraged to give a maximum effort.

MMT: Manual Muscle Testing Grades 0-5
6weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hurriya Sehar, MS*, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR&AHS/23/0741

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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