Functional Power Training on Mobility and Gait Parameters in Cerebral Palsy

NCT06748183 | Completed DMC

• 1 other identifier: REC/RCR&AHS/0706
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Gait Parameters; Mobility; Functional Power Training

Outcome Measures

Primary Outcomes (5)

• Step length

  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.

  5 months

• Stride length

  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.

  5 months

• Cadence

  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.

  5 months

• Gate speed

  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 months

• Step width

  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.

  5 months

Secondary Outcomes (2)

• 6-Minute Walk Test

  5 months

• Timed up and go (TUG) test

  5 months

Study Arms (2)

Functional Power Training

EXPERIMENTAL

Group A will participate in Functional Power Training (FPT) alongside routine physical therapy for children with Cerebral Palsy. The standard therapy includes hot packs for muscle relaxation, isometric exercises for motor skills, muscle strength, and coordination, as well as passive stretching. Therapists will also utilize sit-to-stand exercises to enhance gait and overall functional abilities. Over a 14-week intervention period, FPT will include three 60-minute sessions each week, focusing on improving walking capacity and muscle strength. Each session will consist of a 10-minute warm-up, 35 minutes of 3 to 4 power exercises, and a 15-minute cool-down phase, conducted in small groups of 3-6 children with a supervising therapist. Participants will wear sports shoes without orthoses, and power exercises will target functional, multi-joint movements, emphasizing ankle push-off and velocity, with adjustments made for progressive challenges.

Other: Functional Power Training

Routine Physical therapy

OTHER

Routine physical therapy for children with Cerebral Palsy includes hot packs for muscle relaxation and isometric exercises aimed at improving motor skills, muscle strength, and coordination. Passive stretching is also part of the treatment plan. Therapists use sit-to-stand exercises to enhance gait, posture, and overall functional abilities. Regular progress evaluations are conducted to adjust interventions as needed, ensuring continuous improvement. The overall goal is to optimize mobility, enhance walking ability, and improve the child's quality of life.

Other: Routine physical therapy

Interventions

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.

Functional Power Training

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.

Routine Physical therapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 28786309 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Asiah Fareed, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: December 27, 2024
• Study Start: September 26, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 15, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)