Effect of Leg Pedalling Exercise From Inclined Position

Not Applicable

Completed

• Conditions: Cerebral Palsy Spastic Diplegia
• Interventions: Device: Leg pedalling exercise; Other: The designed physical therapy program

• Registration Number: NCT06233136
• Lead Sponsor: Cairo University

Brief 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

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 Timeline

• Study Start: 2023-03-13
• Primary Completion: 2023-07-15
• Study First Submitted: 2023-07-24
• Study Completion: 2023-08-15
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study First Posted: 2024-01-31
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leg Pedalling exercise and designed physical therapy program	The 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
Designed physical therapy program	The 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
Leg Pedalling exercise and designed physical therapy program	Leg pedalling exercise	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of physical therapy cairo University; 🇪🇬 DOkki, Giza, Egypt