Pediatric Endurance and Limb Strengthening Program With and Without Electrical Muscle Stimulation Among Children With Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Timed Up and Go
Study Overview
Brief Summary
This randomized clinical research will assess the impact of a Pediatric Endurance and Limb Strengthening (PEDAL) program, both with and without Electrical Muscle Stimulation (EMS), on balance, gait, and mobility in children diagnosed with cerebral palsy. A total of 26 individuals will be recruited via purposive sampling and randomly allocated to two groups utilizing the sealed envelope method. Group A will undergo the PEDAL program in conjunction with electrical muscle stimulation (EMS) administered to the quadriceps during stationary cycling, whereas Group B will participate in the PEDAL program exclusively, without EMS. Both groups will participate in supervised sessions three times weekly for four weeks, with each session lasting 60 minutes and comprising a warm-up, cycling-based strength and endurance training, and cool-down stretches. EMS parameters will be implemented in accordance with published protocols for strength (30-80 Hz, 150-350 μs) and endurance (8-35 Hz, 150-250 μs) training. Outcome measures, comprising the Berg Balance Scale, Timed Up and Go Test, and Gait Outcomes Assessment List (GOAL™️) questionnaire, will be evaluated at baseline and following four weeks of intervention. The data will be examined utilizing SPSS version 27. This study aims to determine whether incorporating EMS into a structured pediatric strengthening and endurance regimen yields greater improvements in motor function compared to exercise alone.
Detailed Description
Cerebral palsy (CP) is a predominant cause of childhood impairment, characterized by diminished strength, decreased endurance, inadequate postural control, and restrictions in movement and mobility. Rehabilitation regimens emphasizing endurance and limb strengthening have demonstrated beneficial impacts on motor performance and functional independence in this demographic. Nonetheless, voluntary muscular activation in children with cerebral palsy is frequently constrained, potentially diminishing the efficacy of traditional exercise regimens. Electrical muscle stimulation (EMS) has been implemented as a supplementary method to augment muscle recruitment, reduce stiffness, and enhance neuromuscular control. This trial will examine the Pediatric Endurance and Limb Strengthening (PEDAL) program, both with and without Electrical Muscle Stimulation (EMS), in children diagnosed with cerebral palsy. The PEDAL program employs cycling-based training aimed at enhancing aerobic endurance and lower-limb strength, integrating increasing resistance and functional task elements. In the intervention group, electrical muscle stimulation (EMS) will be administered to the quadriceps muscles during exercise to enhance contractions and potentially increase the training benefits. The study aims to determine if the integration of EMS with endurance and strength training yields superior enhancements in balance, gait, and mobility compared to exercise alone. This project aims to enhance the evidence foundation for pediatric neurorehabilitation, perhaps facilitating the incorporation of EMS-assisted exercise into standard physiotherapy for children with cerebral palsy to optimize motor results and independence.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
This study will be conducted as an open-label randomized clinical trial. Due to the nature of the interventions, neither the participants nor the treating physiotherapists can be masked to group allocation. However, to reduce the risk of bias, outcome assessments will be performed by an independent assessor who will not be informed of the group assignments. This approach ensures that data collection remains objective while allowing the interventions to be delivered appropriately.
Eligibility Criteria
- Ages
- 6 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children from 6 to 10 years old
- •Both gender
- •Participant with spastic cerebral palsy
- •Children who can easily follow verbal directions
- •Participant with good and fair one lower limb selective motor control
- •Participant who can walk independently
- •Participant who lies between 1 to 2 levels of Gross motor function
- •People who are willing to participate
Exclusion Criteria
- •Participant who had gone under any neurological surgery, orthopedic surgery or bachlofen pump implant in previous year
- •Participant who had serial casting or who use any new orthotics from last 3 months
- •Participant with involvement in any exercise, physical therapy, or any sports proceeding within last three months
- •Participant who had any serious medical condition like diabetes, seizure, or any cardiac disease
- •Participant who are involved in any fitness program that can improve cardio respiratory endurance
Arms & Interventions
PEDAL Program with Electrical Muscle Stimulation
Participants in this group will receive the Pediatric Endurance and Limb Strengthening (PEDAL) program combined with electrical muscle stimulation (EMS) applied to the quadriceps muscles during stationary cycling exercises. Each session will last 60 minutes, three times per week for four weeks, and will include warm-up, strengthening and endurance cycling, and cool-down stretching. EMS parameters will follow established clinical guidelines for strength and endurance training.
Intervention: PEDAL Program with Electrical Muscle Stimulation (Device)
PEDAL Program without Electrical Muscle Stimulation
Participants in this group will receive the Pediatric Endurance and Limb Strengthening (PEDAL) program only, without electrical muscle stimulation. The program will also be delivered using stationary cycling for 60 minutes per session, three times per week for four weeks, with warm-up, strengthening and endurance cycling, and cool-down stretching, following the same protocol as the intervention group but without EMS.
Intervention: PEDAL Program without Electrical Muscle Stimulation (Behavioral)
Outcomes
Primary Outcomes
Timed Up and Go
Time Frame: Baseline to 4 weeks
Time (seconds) to stand from a chair, walk 3 meters, turn, return, and sit. Lower times indicate better mobility. Used to determine whether the PEDAL program with or without electrical muscle stimulation produces greater improvement in functional mobility.
Timed Up and Go
Time Frame: Baseline to 4 weeks
Time (seconds) to stand from a chair, walk 3 meters, turn, return, and sit. Lower times indicate better mobility. Used to determine whether the PEDAL program with or without electrical muscle stimulation produces greater improvement in functional mobility.
Secondary Outcomes
- Gait Outcomes Assessment List(Baseline to 4 weeks)
- Gait Outcomes Assessment List(Baseline to 4 weeks)
Investigators
Maryam Iqbal
Student
University of Lahore