Effects of PEDAL Program With and Without EMS On Mobility And Gait In Children With Cerebral Palsy
NCT Number: NCT06460311
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy
Interventions: OTHER: PEDAL and EMS|OTHER: PEDAL
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-06-15
Completion Date: 2024-08-25
Locations: Riphah international university, Lahore, Punjab, 540000, Pakistan

Summary:
PEDAL is a program that focuses on juvenile endurance and limb building for kids with cerebral palsy. Studying how PEDAL with and without Electrical Muscle Stimulation (EMS) affects these metrics in an effort to determine whether exercise and EMS together can improve functional outcomes for young cerebral palsy patients. This research provides important new understandings into customized therapies to improve mobility in kids with this neurological disorder. On -- participants, a randomized controlled study will be carried out. The Zunnorain Foundation in Faisalabad will provide the data through the use of a non-probability convenience sampling method. This study will involve children with cerebral palsy who are between the ages of 6 and 12 and who can understand real directions, as well as those who have fair or good selective motor control. On the other hand, children who use orthotics or take oral medications, or those who have had any surgery or implant within the last year, are not allowed to participate in this study. The 22-person sample is split into two groups. Group A will get a comprehensive intervention consisting of a stationary cycle and electrical muscle stimulation (EMS). . EMS will be applied to the quadricep muscles using specific parameters (frequency = 35 to 70 Hz, pulse duration = 100 μs, pulse period = 50 ms). There are two stages to the stationary cycle program: an endurance phase and a strengthening phase. Group B, on the other hand, will just get the pediatric endurance and limb-strengthening program. Warm-up and cool-down phases of this program include stationary cycle assistance. Each muscle is held for 10 seconds. For four weeks, each of the two groups will receive 60 minutes of treatment three times a week. Using the Gait Outcomes Assessment List (GOALTM) Questionnaire and the time up and go test, gait and mobility will be evaluated in both groups before and after the intervention.

Primary Outcome Measures: Selective Control Assessment of Lower Extremity (SCALE), The SCALE tool is a clinical assessment instrument made for medical practitioners to test selective voluntary motor control (SVMC) without the use of specialized equipment and in 15 minutes. Bilateral examinations of the hip, knee, ankle, subtalar, and toe joints are carried out. Its scoring range is from 0 to 2 where 2 shows normal and 0 shows unable. The maximum score of each leg is 10. The findings demonstrated high reliability and validity ranging from 0.88 to 0.91, 8 Weeks|o Timed Up and Go Test Time Up And Go Test o Timed Up and Go Test o Timed Up and Go Test o Timed Up and Go Test, Time up and go test is used to assess person's static and dynamic mobility. It includes the time person takes to stand, walk, turn, walk and sit down again. Its assessment is done in seconds. It is a very valid and reliable tool 0.97 and 0.99, 8 Weeks|Gait Outcomes Assessment List (GOALTM) Questionnaire Parent Version, This is questionnaire is used to assess functional mobility and gait among childrens of cerebral palsy. This is a 48 item questionnaire with seven domains. Its maximum score is 100. Higher score show higher function. It is a valid and reliable tool. It has a reliability of 0.92 and validity of 0.90., 8 Weeks