Functional Power Training on Mobility and Gait Parameters in Cerebral Palsy

NCT ID: NCT06748183

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-26
• Study Completion Date: 2025-01-15

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Functional Power Training

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.

Group Type: EXPERIMENTAL

Functional Power Training

Intervention Type: 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

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.

Group Type: OTHER

Routine physical therapy

Intervention Type: 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.

Interventions

Functional Power Training

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.

Intervention Type: OTHER

Routine physical therapy

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asiah Fareed, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah International University

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 28786309 (View on PubMed)

Other Identifiers

REC/RCR&AHS/0706

Identifier Type: -

Identifier Source: org_study_id