Clinical trial NCT06522464: Modified Constraint Induced Movement Therapy With And Without Cross Education In Cerebral Palsy
Official title: Effects Of Modified Constraint Induced Movement Therapy With And Without Cross Education On Upper Limb Function In Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Cross education
Modified Constraint-induced
Movement Therapy
dexterity function.
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It will be randomized control trial in which non probability convenient sampling will be used. Two groups of age 6 - 12 years old CP hemiparetic children having the ability to grasp and release light objects, with an extension of at least 20° of the wrist and 10° of the metacarpophalangeal joints of the fingers (from full flexion of the affected hand will be formed in which participants will be randomly divided. Group A will follow the mCIMT Protocol with additional cross education will be given and group B will follow the mCIMT Protocol.
Primary purpose: TREATMENT

Brief summary: A nonprogressive injury to the growing brain, cerebral palsy can impair a child's speech, intellectual ability, and motor development. The kind of impairment will correspond with the affected brain region. Cross education is the process of improving one's strength or skill on the contralateral limb after undergoing unilateral training or practice. This is typically done with a mirror, which activates the mirror neuron on the ipsilateral side. CI, or Constraint-Induced Movement Therapy (CIMT), is a "rehabilitative strategy". It is intended to help people affected by stroke or other neurological problems utilize an affected extremity more functionally. It restrains the limb that is neurologically stronger while applying mass practice concepts. It has also been described as a behavioral approach to neurorehabilitation, with a focus on shaping as a recurring theme, and it uses basic behavioral approaches. The study's objective is to ascertain how cross-education using mCIMT affects cerebral palsy that is hemiparetic.

The Pakistan Society for the Rehabilitation of the Disabled, Lahore (PSRD), Rising Sun Institute for Special Children DHA, and ARK campus Lahore will all provide data for the present study, which is a randomized controlled experiment. Twenty-two volunteers will be randomly assigned to two equal groups for the study. Children with hemiperatic cerebral palsy, aged 6 to 12, of any gender, who have up to 20 degrees of wrist extension, 10 degrees of thumb abduction, and up to 10 degrees of finger extension are eligible to participate in the study. Exclusion criteria included significant shoulder subluxation, uncontrolled systemic hypertension, prior stroke, severe heart failure, and a mini mental state evaluation score of less than 24. The control group will receive conventional physical therapy, whereas the experimental group will receive cross-training using mCIMT and RPT. Result The results before and after the intervention will be analyzed using the Fugl Meyer Upper Extremity Scale and Upper Extremity Functional Index Scale, Jebsen-Taylor Hand Function Test, and Block and Box manual Dexterity Test. Data analysis will be conducted using SPSS version 23.00.

Detailed description: Group A:

For ten weeks, Group A will follow the mCIMT Protocol, which entails 30 minutes of one-on-one therapy three days a week and five hours a day (weekdays) of constraint.

In addition, the student will receive extra cross-education, which will involve practicing reaching tasks, wrist flexion and extension, and non-paretic hand opening and closing for 30 minutes. Activities include building a tower out of cubes in various colors, sorting cubes of similar colors and forms together (square cubes in a column, cylindrical cubes together), gripping a hammer, and various cube and triangular shapes. putting balls in their column, placing various-sized circular forms in their proper locations, and moving items between both hands (18). We'll utilize weight cuffs for every activity.

Group B:

For ten weeks, Group B will follow the mCIMT Protocol, which entails 30 minutes of one-on-one therapy three days a week and five hours a day (weekdays) of confinement.

Eligibility criteria: Inclusion Criteria:

* Age 6 - 12 years old CP hemiparetic children
* having the ability to grasp and release light objects, with an extension of at least 20° of the wrist and 10° of the metacarpophalangeal joints of the fingers (from full flexion of the affected hand)
* having impairment of hand function at levels I to III of the Manual Activity Classification System (MACS)(14).

Exclusion Criteria:

* having visual or auditory disorder
* being subject to seizures or having health problems not associated with CP
* having predominant spasticity or contracture grades more than Grade 3 of the Modified Ashworth Scale in wrist and finger flexors, forearm pronators, and/or thumb adductors
* having received Botulinum neurotoxin injections and/or surgical interventions in the 6-month period before the study

Primary outcomes:
measure: Upper Extremity Functional Index Scale:
timeFrame: 10 weeks
measure: Jebsen-Taylor Hand Function Test:
timeFrame: 10 weeks
measure: Box and Block Test (BBT):
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Rich Care A Rehabilitation Clinic
state: Punjab
Study officials:
affiliation: Riphah International University Lahore
name: Fareeha Kausar, BS-PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones MW, Morgan E, Shelton JE, Thorogood C. Cerebral palsy: introduction and diagnosis (part I). J Pediatr Health Care. 2007 May-Jun;21(3):146-52. doi: 10.1016/j.pedhc.2006.06.007.
citation: Zulu O, Lupenga J, Simpamba MM, Banda MC. Efficacy of Constraint Induced Movement Therapy and Mirror Therapy in Improving Upper Extremity Function in Late Subacute and Chronic Stroke Patients: A randomized crossover trial. Journal of Preventive and Rehabilitative Medicine. 2023;5(2):136-45.
citation: Green LA, Gabriel DA. The cross education of strength and skill following unilateral strength training in the upper and lower limbs. J Neurophysiol. 2018 Aug 1;120(2):468-479. doi: 10.1152/jn.00116.2018. Epub 2018 Apr 18.