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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

40

Phase

  • 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

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
Intervention / Treatment
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

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

Cairo University

Investigators

  • 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)

March 13, 2023

Primary Completion (Actual)

July 15, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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