Comparison of Constraint Induced Movement Therapy and Mirror Therapy

NCT ID: NCT06294444

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-03-15

Brief Summary

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.

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.

Conditions

Hemiplegic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Constraint induced Movement Therapy

Group of 15 members will be given constraint induced movement therapy for 6 weeks.

Group Type: EXPERIMENTAL

Constraint Induced Movement Therapy

Intervention Type: OTHER

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.

Mirror therapy group

Group of 15 members will be given modified constraint induced movement therapy with mirror theray for 6 weeks.

Group Type: EXPERIMENTAL

Mirror therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Mirror Therapy

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hurriya Sehar, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Imran Amjad

Lahore, Punjab Province, Pakistan

Riphah International University

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

Oliva-Sierra M, Rios-Leon M, Abuin-Porras V, Martin-Casas P. [Effectiveness of mirror therapy and action observation therapy in infantile cerebral palsy: a systematic review]. An Sist Sanit Navar. 2022 Aug 16;45(2):e1003. doi: 10.23938/ASSN.1003. Spanish.

Reference Type: BACKGROUND

PMID: 35972309 (View on PubMed)

Other Identifiers

REC/RCR&AHS/23/0741

Identifier Type: -

Identifier Source: org_study_id