Effects of PEDAL Program With and Without EMS On Mobility And Gait In Children With Cerebral Palsy
Key facts
- Who runs it
- Riphah International University
- Where
- Pakistan1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 22 people enrolled
- Started
- 15 Jun 2024
- Ended
- 25 Aug 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- PEDAL and EMS
- PEDAL
- Record updated
- 29 October 2024
Who can take part
- Age
- 6 years to 12 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Age between 6 and 12 years
- Ability to follow simple verbal directions
- Good or fair selective motor control for at least one lower limb
- Ability to walk independently indoors, with or without assistive devices (Levels I-III of the Gross Motor Function
Who cannot take part
- Orthopedic surgery, neurological surgery or baclofen pump implantation within the preceding 12 months
- Initiating oral medications that affect the neuromuscular system, e.g. baclofen, within the preceding three months
- Onset of physical therapy, exercise, sport activity or change in assistive devices for walking within the preceding three months
- Serious medical conditions such as cardiac disease, diabetes or uncontrolled seizures
- Inability or unwillingness to maintain age appropriate behavior
- Serial casting or new orthotics within the preceding three months
- Current participation in a fitness program that includes cardiorespiratory endurance exercise, at least one time per week
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Group ATreatment being tested
PEDAL and EMS
Treatment: PEDAL and EMS
- Group BExisting treatment, for comparison
PEDAL
Treatment: PEDAL
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects Of Pediatric Endurance And Limb Strengthening (PEDAL) Program With And Without Electrical Muscle Stimulation On Mobility And Gait In Children With Cerebral Palsy
- Record updated
- 29 October 2024