Recruiting NCT07244081

Kinesiotherapy on Upper Limb Function and Activities of Daily Living in Children With Hemiplegic Cerebral Palsy

No phase Interventional Hemiplegic Cerebral Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: control, experimental.
Who it may be relevant to: Registry conditions: Hemiplegic Cerebral Palsy. Basic parameters: 8 years — 13 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Pakistan
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Kinesiotherapy on Upper Limb Function and Activities of Daily Living in Children With Hemiplegic Cerebral Palsy

Overview

This study will be randomized controlled trial, data will be collected from BASES special education school sialkot , Allama Iqbal Memorial Hospital, sialkot and Lahore. The study will include 28 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will be age of 8-13 years old of both sexes, ability to follow simple instructions, able to sit or stand with support to participate in physical therapy sessions( MACS level Ⅰ-Ⅲ) and (GMFCS level Ⅰ-Ⅲ), ability to communicate needs and discomfort (verbally or non-verbally), No concurrent participation in other physical therapy and excluded with Severe visual and hearing impairments, severe cognitive disabilities, History of seizures, Recent (within 6 months) or planned orthopedic surgery, Concurrent use of botulinum toxin injections. Experimental group will perform both Kinesiotherapy protocol and conventional physical therapy while Control group will perform only conventional physical therapy for 8 weeks 2-3 times weekly with 45 min of each session. Outcomes to be analyzed will be upper limb function and Activities of daily living (ADLs). Tools used for data collection will be Action Research Arm (ARA) test, Pediatric Evaluation of Disability Inventory (PEDI). Data will be analyzed through SPSS version 26, 27.

Detailed description

Cerebral palsy (CP) is a non progressive neurodevelopmental disorder affecting motor function, resulting from damage to the brain. Hemiplegic CP specifically impacting one side of the body with upper extremity generally more effected than the lower. Twenty percent of children with spastic CP have hemiplegia. Upper limb dysfunction and limited activities of daily living (ADLs) significantly impact quality of life, social participation, and independence. Kinesiotherapy, a movement-based therapy that incorporates movements to improve strength, function and mobility. shows promise effects on stroke patients, but its effectiveness on hemiplegic cerebral palsy requires rigorous investigation. This study aims to investigate the effectiveness of kinesiotherapy in improving upper limb function and ADLs in children with hemiplegic cerebral palsy.

Interventions

Other control
Following baseline assessments, participants will begin their respective 8-week intervention program with 2-3 times per week. The group A will receive base line conventional exercise program with standard physical therapy interventions as follow: * Stretching of tight muscles of affected upper limb. * Weight bearing of affected upper limb. * Manual dexterity exercises like grasp release, pack board activities. * Teaching of ADLs. * Functional task practice(2)
Other experimental
Following baseline assessments, participants will begin their respective 8-week intervention program with 2-3 times per week. The group A will receive base line conventional exercise program with standard physical therapy interventions as follow: * Stretching of tight muscles of affected upper limb. * Weight bearing of affected upper limb. * Manual dexterity exercises like grasp release, pack board activities. * Teaching of ADLs. * Functional task practice(2)

Primary outcome measures

action arm research arm test [Time frame: baseline, 8 weeks]
pediatric evaluation of disability inventory [Time frame: baseline, 8 weeks]

Eligibility criteria

Inclusion criteria

Age: 8-13 years old both sexes
Ability to follow simple instructions, able to sit or stand with support to participate in physical therapy sessions( MACS level Ⅰ-Ⅲ)(9) and (GMFCS level Ⅰ-Ⅲ)(10)
Ability to communicate needs and discomfort (verbally or non-verbally)
No concurrent participation in other physical therapy or rehabilitation programs

Exclusion criteria

Severe visual and hearing impairments that would hinder participation
Severe cognitive or intellectual disabilities that would impede understanding of instructions
History of seizures or other neurological conditions that may impact participation
Recent (within 6 months) or planned orthopedic surgery
Concurrent use of botulinum toxin injections or oral medications affecting muscle tone(2).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Other

Study locations

Pakistan · 1 center

Maria — Sialkot

Publications

Alberti EJ, Targa ADS, Pichorim SF, Brawerman A. Ludic Table: a comparative study between playful rehabilitation and kinesiotherapy in restricting upper limb movements in individuals with stroke. Med Biol Eng Comput. 2022 Apr;60(4):1187-1198. doi: 10.1007/s11517-022-02532-0. Epub 2022 Mar 4. PMID 35244860

Identifiers

NCT: NCT07244081 · REC/RCR&AHS/NAIMAANDLEEB

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗