Aerobic Training On Spasticity And Gross Motor Function In Children With Diplegic Cerebral Palsy

June 27, 2023 updated by: Riphah International University

Effects Of Aerobic Training On Spasticity And Gross Motor Function In Children With Diplegic Cerebral Palsy

To determine the effects of aerobic training on spasticity and gross motor function in children with diplegic Cerebral palsy.Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities of muscle tone, movement and motor skills, and is attributed to injury to the developing brain. . The spastic CP is found to be the commonest presentation followed by athetoid, ataxic and mixed types. Children with cerebral palsy (CP) have decreased capacity to participate in play and sports activities .Reduced capacity to perform typical childhood activities contributes to low habitual physical activity and declining gross motor function in adolescence. Exercise opportunities are restricted in the population of cerebral palsy with spasticity, and so muscle strength may be reduced by disuse. Aerobic Training via Lower-extremity cycling is a rehabilitation tool used by physical therapists to improve spasticity, gross motor function and cardio-respiratory fitness, appears well-suited as a therapeutic intervention for children with CP. The tools used will be GMFM-66 and Modified Ashworth Scale. Study will be conducted on Thirty two patients in two Groups. Group A will be Control Group that will be provided with conventional physiotherapy (Stretching exercises , Trunk control training, walk and breathing exercises) and Group B will be Experimental Group that will be provided with conventional physiotherapy with cycling for 30 minutes with three sessions per week over the period of 12 weeks. Data will be analyzed using spss 22.0.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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.
32

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
      • Lahore, Punjab, Pakistan, 64000
        • Physiogic Physiotherapy Clinic

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

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 6-12 years of age both genders will be included.
  • Ability to follow simple verbal instructions.
  • Ability to walk independently, with or without an assistive device, for short distances (gross motor function classification system [gmfcs] levels i-iii)
  • Spastic Diplegic Cerebral Palsy scoring on Ashworth Scale of 1, 1±, 2

Exclusion Criteria:

  • Orthopedic surgery, neurological surgery, or baclofen pump implantation within the preceding 12 months
  • Botulinum toxin injections within the preceding 3 months
  • Serial casting or new orthotic devices within the preceding 3 months
  • Initiation of oral medications that affect the neuromuscular system (eg, baclofen) within the preceding 3 months
  • Inability or unwillingness to maintain age appropriate behavior
  • Serious medical conditions such as cardiac disease, diabetes, or uncontrolled seizures
  • Significant hip, knee, or ankle joint contractures preventing passive movement of the lower limbs through the pedaling cycle

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: Single

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: Aerobic Training Group
Cycling exercise group along with Conventional therapy
Other: Aerobic Training
This group will be administered with the cycling exercises in addition to the complete plan of care that is being administered to the control group. The cycling intervention will be performed 3 times per week, for 30 minutes, within a 12-week period
Other: Conventional Physiotherapy
This group will be administered with Conventional Physiotherapy that includes 5 minutes of stretching exercises for quadriceps, hamstrings and gastrocnemius, 5 minutes of trunk control training, 5 minutes walking in the hall with and without the therapist assistance, walker or crutches, and finally 5 minutes of breathing exercises for Relaxation
Active Comparator: Conventional Physiotherapy
Strectching with ROM and gait training
Other: Conventional Physiotherapy
This group will be administered with Conventional Physiotherapy that includes 5 minutes of stretching exercises for quadriceps, hamstrings and gastrocnemius, 5 minutes of trunk control training, 5 minutes walking in the hall with and without the therapist assistance, walker or crutches, and finally 5 minutes of breathing exercises for Relaxation

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
Gross Motor Function Measure (GMFM-66)
Time Frame: 8th Week
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes 9 (or leave blank) = not tested (NT).
8th Week
Modified Ashworth Scale (MAS)
Time Frame: 8th week
The modified Ashworth scale(MAS) is a 6-point rating scale that is used to measure muscle tone.(20) The reliability of the modified Ashworth scale was very good reliability and validity
8th week

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.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fareeha Kausar, PP-DPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
November 30, 2021

Primary Completion (Actual)

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 30, 2022

Study Completion (Actual)

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 31, 2022

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).
April 2, 2022

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.
April 2, 2022

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.
April 11, 2022

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 28, 2023

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 27, 2023

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, 2023

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.
  • REC/RCR & AHS/21/0702

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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