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NCT Number: NCT05321797

Aerobic Training On Spasticity And Gross Motor Function In Children With Diplegic Cerebral Palsy

To determine the effects of aerobic training on spasticity and gross motor function in children with diplegic Cerebral palsy.Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities of muscle tone, movement and motor skills, and is attributed to injury to the developing brain. . The spastic CP is found to be the commonest presentation followed by athetoid, ataxic and mixed types. Children with cerebral palsy (CP) have decreased capacity to participate in play and sports activities .Reduced capacity to perform typical childhood activities contributes to low habitual physical activity and declining gross motor function in adolescence. Exercise opportunities are restricted in the population of cerebral palsy with spasticity, and so muscle strength may be reduced by disuse. Aerobic Training via Lower-extremity cycling is a rehabilitation tool used by physical therapists to improve spasticity, gross motor function and cardio-respiratory fitness, appears well-suited as a therapeutic intervention for children with CP. The tools used will be GMFM-66 and Modified Ashworth Scale. Study will be conducted on Thirty two patients in two Groups. Group A will be Control Group that will be provided with conventional physiotherapy (Stretching exercises , Trunk control training, walk and breathing exercises) and Group B will be Experimental Group that will be provided with conventional physiotherapy with cycling for 30 minutes with three sessions per week over the period of 12 weeks. Data will be analyzed using spss 22.0.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physiogic Physiotherapy Clinic

Lahore, Punjab Province, 64000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 6-12 years of age both genders will be included.
  • Ability to follow simple verbal instructions.
  • Ability to walk independently, with or without an assistive device, for short distances (gross motor function classification system [gmfcs] levels i-iii)
  • Spastic Diplegic Cerebral Palsy scoring on Ashworth Scale of 1, 1±, 2

Exclusion criteria

  • Orthopedic surgery, neurological surgery, or baclofen pump implantation within the preceding 12 months
  • Botulinum toxin injections within the preceding 3 months
  • Serial casting or new orthotic devices within the preceding 3 months
  • Initiation of oral medications that affect the neuromuscular system (eg, baclofen) within the preceding 3 months
  • Inability or unwillingness to maintain age appropriate behavior
  • Serious medical conditions such as cardiac disease, diabetes, or uncontrolled seizures
  • Significant hip, knee, or ankle joint contractures preventing passive movement of the lower limbs through the pedaling cycle

Treatment and study plan

Aerobic training

Other

This group will be administered with the cycling exercises in addition to the complete plan of care that is being administered to the control group. The cycling intervention will be performed 3 times per week, for 30 minutes, within a 12-week period

Conventional Physiotherapy

Other

This group will be administered with Conventional Physiotherapy that includes 5 minutes of stretching exercises for quadriceps, hamstrings and gastrocnemius, 5 minutes of trunk control training, 5 minutes walking in the hall with and without the therapist assistance, walker or crutches, and finally 5 minutes of breathing exercises for Relaxation

Primary outcomes

  1. Gross Motor Function Measure (GMFM-66)

    Time frame: 8th Week

    The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes 9 (or leave blank) = not tested (NT).

  2. Modified Ashworth Scale (MAS)

    Time frame: 8th week

    The modified Ashworth scale(MAS) is a 6-point rating scale that is used to measure muscle tone.(20) The reliability of the modified Ashworth scale was very good reliability and validity

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects Of Aerobic Training On Spasticity And Gross Motor Function In Children With Diplegic Cerebral Palsy

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 11, 2022
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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