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Completed

NCT Number: NCT06748183

Functional Power Training on Mobility and Gait Parameters in Cerebral Palsy

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.

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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

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Functional Power Training

Other

Group A will participate in Functional Power Training (FPT) alongside routine physical therapy The exercise protocol aims to enhance strength, mobility, and endurance through resistance training across various functional activities. It includes exercises such as running, walking, chair pushing, stair climbing, propelling a stable scooter, and sideways walking, all performed at 50-70% of the participant's maximum speed. Resistance is added using methods like dragging a loaded box with a belt during running and walking, pushing a chair with a loaded box underneath, wearing a loaded vest while climbing stairs, and attaching a loaded box to a scooter for propulsion exercises. Each exercise involves 6 to 8 repetitions lasting 25 seconds, followed by 30 to 50 seconds of rest. This structured regimen focuses on controlled movement and endurance, providing a comprehensive approach to improving physical performance.

Routine physical therapy

Other

Routine physical therapy for a child with Cerebral Palsy involves hot pack for muscle relaxation and isometric exercises to enhance motor skills, muscle strength, and coordination. Passive stretching will be given as a treatment plan. Therapists employ sit to stand exercise to improve gait, posture, and overall functional abilities. Regular progress evaluations are conducted to adjust interventions, ensuring ongoing improvements.

Primary outcomes

  1. Step length

    Time frame: 5 months

    To measure step length(centimeters), first mark a starting point on the floor, then have the participant walk naturally while measuring the distance between consecutive heel strikes. Repeat this process for several steps and calculate the average of those measurements to determine the participant's typical step length.

  2. Stride length

    Time frame: 5 months

    To measure stride length(meters) first identify the starting point on the walking path and instruct the participant to take several steps. Then, measure the distance between two consecutive heel strikes of the same foot, repeat for multiple strides, and calculate the average to determine the participant's typical stride length.

  3. Cadence

    Time frame: 5 months

    To measure cadence(steps/min), choose a specific time interval and instruct the participant to walk within that period while counting the number of steps taken. Repeat the process for accuracy and calculate the average steps per minute to determine the participant's cadence.

  4. Gate speed

    Time frame: 5 months

    To measure gait speed(meters/sec), mark the starting and finishing points on a straight path, and instruct the participant to walk at a comfortable pace while measuring the time taken to cover the distance. Repeat the process for accuracy, then calculate gait speed by dividing the distance by the time taken to complete it.

  5. Step width

    Time frame: 5 months

    To measure step width(centimeter), define a walking path and instruct the participant to walk naturally while measuring the lateral distance between the midpoints of successive footsteps. Repeat this measurement for multiple steps and calculate the average step width to analyze the participant's walking pattern.

Secondary outcomes

  1. 6-Minute Walk Test

    Time frame: 5 months

    Set up a marked straight pathway and instruct the individual to walk as far as possible within a 6-minute timeframe, encouraging them to maintain a consistent pace while providing periodic time updates. At the end of the session, measure the total distance covered in meters to assess their functional capacity

  2. Timed up and go (TUG) test

    Time frame: 5 months

    Start with the individual seated in a chair, and upon the signal, have them stand, walk three meters, turn, walk back, and sit down. Measure the total time taken for this sequence to assess functional mobility, with longer times suggesting potential mobility challenges.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Functional Power Training on Mobility and Gait Parameters in Children With Cerebral Palsy.

Acronym: FPTCP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Jan 23, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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