Effects of PEDALS Program Versus Lower Limb Strength Training in Diplegic CP

Riphah International University

Status: Completed

Conditions: Cerebral Palsy,Diplegic

Treatments: Other: Pediatric Endurance and Limb Strengthening Program (PEDALS) and Lower Limb Strength Training; Other: Lower Limb Strength Training Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05903534

REC/RCR&AHS/23/0702

Details and patient eligibility

About

Cerebral palsy (CP) is a neurodevelopmental disorder is caused by damage to the developing brain and is characterized by abnormalities of muscle tone, mobility, and motor abilities. CP may only be recognized at 3-5 years of age. Pediatric endurance and limb strengthening (PEDALS) program is important to achieve endurance, gross motor function and some measure of strength in patients with diplegic cerebral palsy. The aim of this study is to evaluate the comparative effects of pediatric endurance and limb strengthening program with lower limb strength training in diplegic cerebral palsy.

Full description

A randomized control trial will be conducted through convenient sampling. Subjects will randomly allocated into two groups, group A will receive pediatric endurance and limb strengthening program, while group B will receive lower limb strength training. The duration of the treatment will be 8 weeks. Goniometer, six minute walk test and gross motor function measure scale-88 will be used to as outcome measure. Goniometer measures the available range of motion at a joint, six minute walk test measure cardiorespiratory or aerobic endurance, the GMFM-88 provides more descriptive information about motor function for very young children or children with more complex motor disability, Data will be analyzed on SPSS version 27, normality of the data will be checked and tests will be applied according to the normality of the data either it will be parametric test or non-parametric based on the normality.

Enrollment: 24 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria: •

  • Age between 6-12 years of age, children with cerebral palsy
  • Ability to follow simple verbal direction
  • Ability to walk independently with or without an assistive device for short distance (GMFCS) level 1-11
  • Good or fair selective voluntary motor control for at least one limb

Exclusion Criteria:

• Orthopedic surgery
• Botulinum toxin injection within the preceding 3 months
• Serial casting or new orthotic devices within the preceding 3 months
• Initiation of oral medication that effect the neuromuscular system
• Significant hip, knee or ankle joint contractures
• Inability of unwillingness to maintain age- appropriate behavior

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Pediatric Endurance and Limb Strengthening Program (PEDALS) Group

Active Comparator group

Description:

In this group patients will performed pediatric endurance and limb strengthening (PEDALS) program. The stationary cycling intervention was performed 60 min per day, 3 times per week, for a total of 24 sessions, within a 8 week period. The longer session duration was designed to allow adequate rest intervals between set (1-3 minutes). A generalized stretching program was performed prior to cycling.

Treatment:

Other: Pediatric Endurance and Limb Strengthening Program (PEDALS) and Lower Limb Strength Training

Lower Limb Strength Training Group

Active Comparator group

Description:

In this group patients will performed lower limb strengthening intervention was performed 3 times per week, for a total of 24 sessions, within a 8 week period using the functional strength training (for eccentric, concentric, and isometric contraction), plyometric exercises (including jumping), and balance training. Before each training session, there was a warm-up period with 5 to 10 minutes of dynamic activities (eg, jogging). After training, there was a cool down period with 5 to 10 minutes of dynamic stretching exercises. In addition to rest intervals, after each training session, there was a rest interval to prevent muscle fatigue and injury

Treatment:

Other: Lower Limb Strength Training Group