Effect of Leg Pedalling Exercise From Inclined Position

January 30, 2024 updated by: Alaa Bahgat mahmoud Hasan, Cairo University

Effect of Leg Pedalling Exercise From Inclined Position on Functional Ability and Trunk Control in Children With Diplegic Cerebral Palsy

Statement of the problem:- Does the lower limb pedalling exercise from inclined position improve functional ability and trunk control in children with diplegic cerebral palsy? Null Hypothesis:- There will be no effect of lower limb pedalling exercise from inclined position on functional ability and trunk control in children with diplegic cerebral palsy

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.

Detailed Description

Subjects A convenient sample of children diagnosed as spastic diplegic cerebral palsy (CP) from both sexes will be recruited based on a pilot study according to the inclusion and exclusion criteria. They will be selected from the out-patient private clinics in Giza and Tenth of Ramadan City.

Study design:

Randomized controlled clinical trial. Children will receive intervention type randomly, 15 child received the designed physical therapy program and the pedaling exercise from inclined position and the other 15 child receieved the designed physical therapy program only. Children will be assessed by measuring functional ability with Gross Motor Functional measures and trunk control with trunk control measurement scale

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.
40

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

  • Egypt
    • Giza
      • DOkki, Giza, Egypt, 12613
        • Faculty of Physical Therapy Cairo University

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:

.Age ranges from 6-9 years. .Grade 1, 1+ of the Modified Ashworth Scale.

.Level II, III according to Gross MotorFunctional Classification System (GMFCS).

.Able to pedal independently on a static bicycle.

.Ability to follow command.

Exclusion Criteria:

.Significant visual or auditory impairments.

.Structural or fixed deformities of lower extremities.

.Perception disorders.

.Botox injection in the lower extremity in the past 6 months.

.Lower extremity surgery within the past 6 months.

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: Leg Pedalling exercise and designed physical therapy program

Each child in the experimental group will be positioned in semi-reclined position with 45 degree trunk flexion during the application of cycling Sessions will be 30 minutes per session, three times per week, for two successive months The designed physical therapy program It will be applied for all participated children in both groups. It includes;

  1. Flexibility exercises
  2. Static and dynamic balance exercises
  3. Functional training Sessions will be 45 minutes per session, three times per week, for two successive month
Device: Leg pedalling exercise
Each child in the experimental group will be positioned in inclined position and will cycle through the range of motion under the supervision of the researcher
Other Names:
  • Leg ergometer
Other: The designed physical therapy program

It applied for all participated children in both groups. It includes;

  1. Flexibility exercises
  2. Static and dynamic balance
  3. Functional training exercises
Other Names:
  • Traditional physical therapy program
Active Comparator: Designed physical therapy program

The designed physical therapy program It will be applied for all participated children in both groups. It includes;

  1. Flexibility exercises
  2. Static and dynamic balance exercises
  3. Functional training Sessions will be 45 minutes per session, three times per week, for two successive month
Other: The designed physical therapy program

It applied for all participated children in both groups. It includes;

  1. Flexibility exercises
  2. Static and dynamic balance
  3. Functional training exercises
Other Names:
  • Traditional physical therapy program

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
The gross motor function scale
Time Frame: 2 months for each participant
Assessment of change of functional ability carried out by using gross motor function measures
2 months for each participant
Assessment of trunk control
Time Frame: 2 months for each participant
Assessment of change of trunk control carried out by using trunk control measurement scale
2 months for each participant

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.
Cairo 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.
  • Study Director: NANEES E Mohamed, Phd, PROFESSOR

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.
March 13, 2023

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.
July 15, 2023

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.
August 15, 2023

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).
July 24, 2023

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.
January 30, 2024

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.
January 31, 2024

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.
January 31, 2024

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.
January 30, 2024

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.
January 1, 2024

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.
  • P.T.REC/012/004085

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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