NCT07244081

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2025

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

Kinesiotherapy, Hemiplegic Cerebral Palsy, Upper limb function, ADLs

Outcome Measures

Primary Outcomes (2)

  • action arm research arm test

    The Action Research Arm Test (ARAT) is a 19 item observational measures used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task maximum score 57 means better performance

    baseline, 8 weeks

  • pediatric evaluation of disability inventory

    The PEDI is a standardized clinical assessment tool designed to measure the functional performance of children with typical development whose chronological age is below 7.5 years old, and the functional performance of children with disabilities whose functional capabilities are below those of a 7.5-year-old child. The PEDI can be used for children with developmental disabilities aged 6 months to 21 years and for individuals without disabilities aged less than 7 years(12) The PEDI is composed of 3 domains: functional skill, caregiver assistance, and modification. Each domain includes 3 sub-domains: self-care, mobility, and social function. The functional skill domain, which was used for measuring ADL performance, consists of 197 specific questions. Each child is assigned either 1 point for being capable of performing the assigned task or 0 points for incomplete performance or being unable to perform the task. The reliability of the functional skill subscale of the PEDI is very high.

    baseline, 8 weeks

Study Arms (2)

control group

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)

Other: control

experimental group

EXPERIMENTAL

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

Other: experimental

Interventions

controlOTHER

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)

Also known as: baseline
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)

Also known as: kinesiotherapy
experimental group

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria

Sialkot, Punjab Province, 51040, Pakistan

RECRUITING

Related Publications (1)

  • 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: 35244860BACKGROUND

MeSH Terms

Interventions

BaseLine dental cement

Study Officials

  • Naima Andleeb, MS PT

    Riphah Internatonal university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad asif javed, MS PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: . 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

October 22, 2025

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations