Effect of Leg Pedalling Exercise From Inclined Position

Cairo University (CU)

Status: Completed

Conditions: Cerebral Palsy Spastic Diplegia

Treatments: Device: Leg pedalling exercise; Other: The designed physical therapy program

Study type: Interventional

Funder types: Other

Identifiers

NCT06233136

P.T.REC/012/004085

Details and patient eligibility

About

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

Full 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

Enrollment: 40 patients

Sex: All

Ages: 6 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Leg Pedalling exercise and designed physical therapy program

Experimental group

Description:

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

Treatment:

Other: The designed physical therapy program

Device: Leg pedalling exercise

Designed physical therapy program

Active Comparator group

Description:

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

Treatment:

Other: The designed physical therapy program