Clinical trial NCT03691506: Comparison of CIMT and Its Modified Form on Upper Motor Function Outcomes in Hemiplegic Cerebral Palsy.
Official title: Comparison of Constraint-induced Movement Therapy and Its Modified Form on Upper Motor Function Outcomes and Psychosocial Impact in Hemiplegic Cerebral Palsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Keywords: Cerebral Palsy
Constraint-Induced Movement Therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this research is to compare the effect of classic constraint-induced movement therapy and its modified form on upper extremity motor function outcomes and psychosocial impact in hemiplegic cerebral palsy. Randomized controlled trials with 2-3 weeks follow-up. The sample size is 40. The subjects are divided in two groups, 20 subjects in classical CIMT group and 20 in modified CIMT group. Study duration is of 6 months. Sampling technique applied will be purposive non probability sampling technique. Only 4-12 years individual with hemiplegic cerebral palsy are included. Tools used in the study are Box and Block test, Cerebral palsy (quality of life), Kid Screen 27 and QUEST (quality of upper extremity skill test). Data will be analyzed through SPSS 21.

Detailed description: Cerebral palsy is known as a neurodevelopment disease that begins in the early childhood and persists throughout the life. In the past, it was a challenge to define the term CP. Many attempts were made to overcome this. In 1964, definition for cerebral palsy was given that is still used worldwide. According to that cerebral palsy (CP) is not just the disorder of posture but movement also and it happens due to lesion or damage of an immature brain. It is a disorder of human brain that is non-progressive. The main focus of the definition was on the motor impairment. Cerebral palsy can lead to activity limitation. As CP includes motor disorders so it encounters disturbances like cognition, sensation, communication, seizures and behavioral disorder.

The frequency with which CP occurs is of importance as it is the first effort towards its prevention. It also estimates the supportive services and the medical care that is required for children with cerebral palsy and also their families. Many studies were conducted to check the trends of Cerebral Palsy occurrence depending upon the low birth weight.

The definition of cerebral palsy shows that it is just a single disorder infect it is collection of disorders. Prevalence of cerebral palsy shows that out of 1000 births, there are 2.0-2.5 children are victims of cp. However in few children, the causes of CP are still not known. Moreover, the causes need to be discriminated from the risk factors. Prenatal events are also responsible for CP. Such events may include toxins, maternal infection for example rubella or brain malformations. One of the prenatal causes is birth asphyxia. A small ratio of CP can be the result of perinatal causes. 10% cases of cp are result of postnatal causes. The causes can be accidental or non-accidental. Meningitis is also one of the postnatal causes.

Out of all types of cerebral palsy, one-third is spastic hemiplegic. Birth trauma can be the cause of spastic hemiplegia. Researches show that there is more ratio of right hemiplegia than the left hemiplegia. The most common form of CP that is seen in premature children is spastic diplegia. In spastic diplegia, spasticity affects lower limbs more than the upper extremity. Birth asphyxia is seen in children born with the choreo-athetosis.

Traditional hemiplegic patients receive occupational and physical therapy to improve their functional skills. Constraint induced movement therapy (CIMT) is an approach to treating the hemiparesis that facilitate use of hemiparetic arm through constraint the unaffected arm.it has been shown to be effective treatment in hemiparesis in adult and children.

In this study, I hypothesized that there is a difference between the effectiveness of classic CIMT with modified CIMT on upper extremity motor function outcomes in children with hemiplegic cerebral palsy. The purpose of this study is to compare the effects of classic CIMT with modified CIMT on upper extremity motor functions and to see the psychosocial impact of CIMT on hemiplegic cerebral palsy.

LITERATURE REVIEW:

There is injury of undeveloped brain in Children with CP. Children with hemiplegic cerebral palsy (HCP) have trouble using their affected arm and hand on one side of their body. Evidence from randomized controlled trials, clinical controlled trials, and systematic reviews has shown constraint therapy improves hand and arm movement in children with hemiplegic cerebral palsy. According to a research review done in 2014; it is seen that CIMT proved to be beneficial in improving hand function as compared to the conventional therapy. A comparison was done between equal intensity of bimanual training and CIMT. Results showed same progress in hand function.

A comparison was done between equal intensity of hand arm bimanual training (HABIT) and CIMT. Results showed same progress in hand function. Modified constraint-induced movement therapy improved isolated functions of the hemiplegic arm better than intensive bimanual training, but regarding spontaneous hand use in everyday life both methods lead to similar improvement. This suggests mCIMT should be paired with BIT to achieve optimal results for children with HCP who present with difficulties in both unimanual and bimanual hand functions. A study combining mCIMT and BIT demonstrated more frequent and more effective use of the affected limb, and better performance inself-care and leisure tasks.

Children and parents from both groups (CIMT and BIT) reported a significant improvement in their or their child's feelings about functioning as well as participation and physical health. The parents of children receiving CIMT reported positive and sustained changes in their child's social well-being (CPQOL-Child). The CIMT group showed significant improvements in physical well-being, psychological well-being, moods and emotions.

Eligibility criteria: Inclusion Criteria:

* 4 to 12 years CP with unilateral, bilateral or severely asymmetrical impairment Manual Ability Classification System(MACS) I, II or III
* Wrist extension capacity at least 20°; fingers with 10° of complete flexion
* Children able to follow Command

Exclusion Criteria:

* Children also having disabilities other than Cerebral palsy
* Contractures that significantly limit functional arm use.
* Children with MR.

Primary outcomes:
measure: Change from Baseline [Box And Block Test (BBT)] at 3rd week
timeFrame: 3rd week
Secondary outcomes:
measure: Change from Baseline [Quality Of Upper Extremity Skill Test (QUEST)] at 3rd week
timeFrame: 3 weeks.
measure: Change from Baseline [Kid Screen 27] at 3rd week
timeFrame: 3 weeks.
measure: Change from Baseline [Cerebral Palsy Quality of Life CP(QOL)] at 3rd week
timeFrame: 3 weeks.
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
state: Federal
Study officials:
affiliation: Riphah International University
name: Imran Amjad, PHD
role: PRINCIPAL_INVESTIGATOR
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