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

NCT ID: NCT07244081

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-22
• Study Completion Date: 2026-01-30

Brief Summary

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.

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.

Conditions

Hemiplegic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

control group

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)

Group Type: OTHER

control

Intervention Type: OTHER

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)

experimental group

Kinesiotherapy tailored exercises focusing on movement and exercise, The movements are as follows:Sitting on a chair, the participant had to lean forward to pick up an object previously placed on the floor.Sitting on a chair, the participant had to rotate the upper body, reaching out and grabbing an object on its side, at the height of his shoulders.Sitting on a chair, the participant had to clasp his hands and flex the shoulders.

Sitting on a chair in front of a table, the participant had to take objects numbered in ascending order and hand them over to the therapist.

Sitting on a chair holding a stick, the participant had to place one hand above the other, raising his hands as if holding on to the stick.Sitting on a chair in front of a table, the patient had to find similar playing cards. All cards were face down. Sitting on a stretcher, the participant had to laterally tilt his trunk, putting the weight on the upper limbs. The therapist maintained the elbow extension

Group Type: EXPERIMENTAL

experimental

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: OTHER

Other Intervention Names

baseline; kinesiotherapy

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).

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naima Andleeb, MS PT

Role: PRINCIPAL_INVESTIGATOR

Riphah Internatonal university

Locations

Maria

Sialkot, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

imran amjad, Phd

Role: CONTACT

imran.amjad@riphah.edu.pk

9233224390125

Muhammad asif javed, MS PT

Role: CONTACT

a.javed@riphah.edu.pk

923224209422

Facility Contacts

maria, MS

Role: primary

bases.sialkot49@gmail.com

03000209022

References

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.

Reference Type: BACKGROUND

PMID: 35244860 (View on PubMed)

Other Identifiers

REC/RCR&AHS/NAIMAANDLEEB

Identifier Type: -

Identifier Source: org_study_id