Effect of Coordinative Locomotor Training in Children With Cerebral Palsy (CLT-PHYSIO-CP)

June 14, 2026 updated by: Muhammad Muneeb Jafar, University of Faisalabad

Effect of Coordinative Locomotor Training as Compared to Conventional Physio Therapy in Improving Interlimb Coordination and Dynamic Balance Among Children With Spastic Hemiplegic Cerebral Palsy

Cerebral palsy is a brain disorder that affects how children move their bodies. Children with spastic hemiplegic CP have stiffness on one side of the body, making it hard to walk and balance. This study will test a special exercise program called Coordinative Locomotor Training (CLT). CLT uses running and skating movements to train both arms and legs to work together. The investigator want to see if CLT works better than regular physiotherapy for improving coordination and balance in participants. Half of the children will do CLT, and the other half will do regular exercises. The investogar will measure their balance and walking ability before and after 4 weeks of training.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a double-blinded, parallel-group, randomized controlled trial conducted at the Department of Rehabilitation Sciences, The University of Faisalabad. A total of 38 children diagnosed with spastic hemiplegic cerebral palsy (GMFCS Level I-II), aged 8 to 12 years, will be recruited from pediatric physiotherapy centers. Participants will be randomly assigned (1:1 ratio) using a computer-generated randomization list to either the Experimental Group (CLT) or the Control Group (CPT). The Experimental Group (n=19) will receive Coordinative Locomotor Training based on Proprioceptive Neuromuscular Facilitation (PNF) sprinter and skater patterns. The intervention will be delivered in three postures (supine, sitting, and single-leg stand) for 3 sets of 5 repetitions with a 10-second hold and 10-second rest, lasting 30 minutes per session, 3 times per week for 4 weeks (total 12 sessions). The Control Group (n=19) will receive conventional physiotherapy consisting of hot pack application for 10 minutes, rotational exercises for 5 minutes, followed by stretching and resistance training for 15 minutes, lasting 30 minutes per session, 3 times per week for 4 weeks (total 12 sessions). The primary outcome measures are interlimb coordination (assessed via 1-step time asymmetry and stride time variability) and dynamic balance (Pediatric Balance Scale). Secondary outcomes include functional gait (TUG and 10MWT) and static balance (one-leg stand test).Participants will not know whether they are in experiment or control group. A blinded assessor will evaluate all participants at baseline (Week 0) and post-intervention (Week 8). Data will be analyzed using SPSS version 23.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Faisalābad, Punjab Province, Pakistan, 3800
        • The University of Faisalabad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children aged 8 to 12 years.
  • Diagnosed with spastic hemiplegic cerebral palsy.
  • GMFCS Level I or II.
  • Ability to follow simple verbal instructions.
  • Medically stable with no changes in anti-spastic medication in the last 3 months.

Exclusion Criteria:

  • Orthopedic surgery or Botulinum toxin injection in the last 6 months.
  • Severe cognitive impairment preventing cooperation.
  • Visual or vestibular deficits affecting balance.
  • Uncontrolled seizures.
  • Other neurological or musculoskeletal disorders unrelated to CP.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Coordinative Locomotor Training (CLT)
PNF-based sprinter and skater patterns in supine, sitting, and standing.
Other: Coordinative Locomotor Training
Participants perform PNF sprinter pattern (flexion/adduction/external rotation on one side with extension/abduction/internal rotation on the opposite side) and skater pattern (reciprocal upper and lower limb movements). Exercises are done for 3 sets of 5 reps, 10-sec holds, 30 min/session, 3x/week for 4 weeks.
Active Comparator: Conventional Physiotherapy (CPT)
ROM exercises, stretching, and resistance training.
Other: Conventional Physiotherapy
rotational exercises (5 min), then passive stretching of hamstrings, quadriceps, and ankle plantarflexors combined with resistance training using elastic bands (15 min).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Interlimb Coordination
Time Frame: Baseline (Week 0) and Post-intervention (Week 8)
Measured by 1-step time asymmetry (NAI) during gait analysis.
Baseline (Week 0) and Post-intervention (Week 8)
Change in Dynamic Balance
Time Frame: Baseline (Week 0) and Post-intervention (Week 8)
Measured by the Pediatric Balance Scale (PBS). A 14-item scale scoring from 0 to 56. Higher scores indicate better balance.
Baseline (Week 0) and Post-intervention (Week 8)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Functional Gait Speed
Time Frame: Baseline (Week 0) and Post-intervention (Week 8)
Measured by the Time Up and Go (TUG) test in seconds,
Baseline (Week 0) and Post-intervention (Week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Faisalabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TUF/EIRB/ 199 /26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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