Effect of Leg Pedalling Exercise From Inclined Position

Cerebral Palsy Spastic Diplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06233136
• Other study ID #: P.T.REC/012/004085
• Status: Completed
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: August 15, 2023

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy Spastic Diplegia

Intervention

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:
• The designed physical therapy program
It applied for all participated children in both groups. It includes; Flexibility exercises Static and dynamic balance Functional training exercises

Locations

Country	Name	City	State
Egypt	Faculty of physical therapy cairo University	DOkki	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The gross motor function scale	Assessment of change of functional ability carried out by using gross motor function measures	2 months for each participant
Primary	Assessment of trunk control	Assessment of change of trunk control carried out by using trunk control measurement scale	2 months for each participant