Clinical trial NCT06294444: Comparison of Constraint Induced Movement Therapy and Mirror Therapy
Official title: Effects of CIMT With and Without Mirror Therapy on Upper Limb Function in Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Keywords: mCIMT, Hemiplegia, Mirror therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: fine motor skills
timeFrame: 6weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Imran Amjad
state: Punjab
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hurriya Sehar, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.