Clinical trial NCT06748183: Functional Power Training on Mobility and Gait Parameters in Cerebral Palsy
Official title: Effects of Functional Power Training on Mobility and Gait Parameters in Children With Cerebral Palsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Gait Parameters
Mobility
Functional Power Training
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It will be a randomized control trial employing nonprobability convenient sampling. Two groups, comprising participants aged 6 to 12, will be formed and randomly divided. Group A will undergo Functional Power Training (FPT) alongside Routine Physical Therapy (RPT), while Group B will receive only Routine Physical Therapy (RPT). This intervention aims to compare the effects of combined functional training and routine therapy against routine therapy alone, focusing on improvements in gait parameters and mobility among children with Cerebral Palsy.
Primary purpose: TREATMENT

Brief summary: Cerebral Palsy is a lifelong neuromuscular disorder impacting movement, posture, and muscle control, ranging from mild hand weakness to severe paralysis. Risk factors are grouped into specific stages: preconception (linked to the mother's health), prenatal (during pregnancy), perinatal (at birth), and the neonatal and infant stages. Functional power training is employed to improve the functional abilities of children with Cerebral Palsy by involving them in various power-based exercises to strengthen muscles, increase power, and build endurance. This study aims to evaluate the impact of functional power training on gait and mobility in children with Cerebral Palsy.

Detailed description: Cerebral Palsy (CP) is a chronic neuromuscular disorder that affects movement, posture, and muscle control, with symptoms ranging from mild weakness to severe paralysis. The risk factors for CP are classified into preconception, prenatal, perinatal, and neonatal categories. Functional power training (FPT) is a therapeutic approach aimed at improving muscle strength, power, and endurance in children with CP. This study seeks to evaluate the impact of FPT on gait parameters and mobility in children with CP. This randomized controlled trial will include 26 children, aged 6 to 12 years, with Gross Motor Function Classification System (GMFCS) I or II. Participants will be randomly assigned to either the experimental group (FPT plus routine physical therapy) or the control group (routine physical therapy alone). Exclusion criteria include recent botulinum toxin A treatment, serial casting within the last 6 months, or selective dorsal rhizotomy. Gait parameters (step length, stride length, cadence, gait speed, and step width) and mobility outcomes (6MWT and Timed Up and Go test) will be assessed before and after the intervention. Data will be analyzed using SPSS version 23.

Eligibility criteria: Inclusion Criteria:

* Age 6 to 12
* Gross Motor Function Classification System (GMFCS) I and II
* Either gender will be included

Exclusion Criteria:

* Treatment with botulinum toxin A in lower limb
* Serial Casting of lower limb less than 6 months before the start of the functional power training
* Selective dorsal rhizotomy treatment
* Children who did not (yet) choose walking as their preferred way of mobility

Primary outcomes:
measure: Step length
timeFrame: 5 months
measure: Stride length
timeFrame: 5 months
measure: Cadence
timeFrame: 5 months
measure: Gate speed
timeFrame: 5 months
measure: Step width
timeFrame: 5 months
Secondary outcomes:
measure: 6-Minute Walk Test
timeFrame: 5 months
measure: Timed up and go (TUG) test
timeFrame: 5 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Asiah Fareed, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Vulpen LF, de Groot S, Rameckers E, Becher JG, Dallmeijer AJ. Improved Walking Capacity and Muscle Strength After Functional Power-Training in Young Children With Cerebral Palsy. Neurorehabil Neural Repair. 2017 Sep;31(9):827-841. doi: 10.1177/1545968317723750. Epub 2017 Aug 8.