Clinical trial NCT04858646: Aerobic Exercises and Gross Motor Function in Spastic Cerebral Palsy
Official title: Effects of Aerobic Exercises on Gross Motor Function in Children With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Cerebral Palsy
Keywords: Cerebral palsy
Gross motor function measure
Aerobic exercises
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 34
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this research is to find the effects of aerobic exercise on gross motor function in cerebral palsy patients. Quasai experimental study done at Noor Zainab Rehabilitation center, Lahore. The sample size was 34. The subjects were divided in two groups, 17 subjects with aerobic exercise 17 children with conventional treatment. Sampling technique applied was purposive non probability sampling. Only 7-12 years individuals with GMFCS level I- III were included. Tools used in the study were Gross motor function measure (GMFM-66 and 88) .Data was be analyzed through SPSS 21.

Detailed description: Cerebral palsy" an umbrella term for a group of irreversible and non-progressive abnormalities of the fetal or neonatal brain, this can lead to disorders of movement and posture. National Institute for Health and Care Excellence (NICE) states that, it is the most common cause of physical disability in children and young people in the developing world. CP is condition with multiple causes; multiple clinical types; multiple associated developmental pathologies, such as intellectual disability, autism, epilepsy, and visual impairment; and more recently multiple rare pathogenic genetic variations Motor disability in cerebral palsy is related with sitting, standing, walking and running appears as the main symptom in children with CP, the assessment and management of CP have focused on gross motor function. The Gross Motor Function Measure (GMFM) is designed by Russell et al. in 1993 is used to measure the level of motor development and changes of gross motor function in a standardized environment in children with CP. GMFM-66 is comprised of a subset of the 88 items identified as contributing to the measure of gross motor function in children with CP, ranging from 0 (lowest motor function) to 100 (highest motor function). Cardiorespiratory endurance is an integral component of physical fitness and has been identified as the most important fitness component associated with health and mortality. In clinical practice, rebound is usually offered as a 20 minute session, once per week for 6 weeks. Typical rebound therapy programs target gross motor skill development, such as balance while sitting, kneeling, standing and walking; functional transfers such as rolling and sit to stand; aerobic activity such as jumping. It is theorized that using a trampoline improves muscle tone, posture, balance, kinesthetic awareness, movement, body awareness, and communication. Aerobic exercise may improve activity as indicated by motor function but does not appear to improve gait speed, walking endurance, participation or aerobic fitness among children with CP in the short or intermediate term. Researcher to conduct a study on effects of robot assisted gait training in CP children, collect data from 14 consecutive children affected by CP, each session of 60 minutes, 20 daily sessions for 5 days per week. Saeid Fatorehchy et al. in 2019 conducted an RCT, this study was to evaluate the effects of aquatic therapy in cerebral palsy patients. Six children with average age of 7 years 4 months are included. Each sessions lasted for 50 minutes, comprising 10 minutes of warm up and stretching and 40 minutes of walking in pool at different at different water depths.

Maria A. Fragala-Pinkham et al. stated that participation in routine physical activity is important for health promotion and prevention of chronic health condition. Participating in sports and active recreation can be beneficial on several levels for children and adults with CP. At the body function and structure level of the ICF, improvement in fitness and endurance have been documented for children and young with CP. Sports equipment that can be use are cycling, swimming, sketching and outdoor active recreation.

Eligibility criteria: Inclusion Criteria:

* Children with CP at GMFCS level I- III

Exclusion Criteria:

* Botulinum toxin-A- injection in lower limb last 6 months
* \<0° dorsiflexion in ankle
* Unable to cooperate and follow instructions
* Children with progressive brain disorder

Primary outcomes:
measure: Gross motor function measure (GMFM-66 and 88)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Tehreem Mukhtar, MS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ryan JM, Cassidy EE, Noorduyn SG, O'Connell NE. Exercise interventions for cerebral palsy. Cochrane Database Syst Rev. 2017 Jun 11;6(6):CD011660. doi: 10.1002/14651858.CD011660.pub2.
citation: Digiacomo F, Tamburin S, Tebaldi S, Pezzani M, Tagliafierro M, Casale R, Bartolo M. Improvement of motor performance in children with cerebral palsy treated with exoskeleton robotic training: A retrospective explorative analysis. Restor Neurol Neurosci. 2019;37(3):239-244. doi: 10.3233/RNN-180897.
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