Effects of PEDAL Program With and Without EMS On Mobility And Gait In Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06460311
• Other study ID #: REC/RCR &AHS/23/O799
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: August 25, 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: Imran Amjad, PhD
• Phone: 033224390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Group A (PEDAL+EMS Group) Group A will receive EMS with Stationary cycle. EMS will be given at quadricep muscles. The pads will placed vertically in the midline along the knee and the pelvis. EMS will be given at frequency = 35 to 70 Hz, pulse duration = 100 μs, pulse period = 50 ms, Intervention will be will be performed for 60 minutes for 3 times or week for 4 weeks. Contrastingly, the stationary cycle will be administered in two distinct phases: strengthening and endurance. During the lower extremity strengthening phase, the cycle seat will be adjusted by sliding it backward along a linear track. The resistance of the cycle will be augmented once the participant can easily complete 10 revolutions with the seat unlocked. Conversely, the endurance training phase will involve securing the cycle seat while children cycle at their maximum capacity, aiming for a heart rate between 70% to 80% of their maximum. Prior to and following each session, stretching exercises targeting the calf, quadricep, and hamstring muscles will be administered, with a 10-second hold during both the warm-up and cool-down sessions. Pre and post measurements will be conducted to evaluate mobility and gait. Group B (PEDAL Group ChatGPT In Group B, participants will exclusively receive the Pediatric Endurance and Limb Strengthening program without EMS. Similar to Group A, this program will incorporate the use of a stationary cycle. The warm-up and cool-down periods will also include a 10-second hold for each targeted muscle group. The intervention will consist of 60-minute sessions conducted three times per week over a span of four weeks. Pre and post-assessments of gait and mobility will be conducted using the Gait Outcomes Assessment List (GOALTM) Questionnaire and the time up and go test.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: August 25, 2024
• Est. primary completion date: August 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Orthopedic surgery, neurological surgery or baclofen pump implantation within the preceding 12 months
• Serial casting or new orthotics within the preceding three 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
• Inability or unwillingness to maintain age appropriate behavior
• Serious medical conditions such as cardiac disease, diabetes or uncontrolled seizures
• Current participation in a fitness program that includes cardiorespiratory endurance exercise, at least one time per week

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• PEDAL and EMS
Group A will receive EMS with Stationary cycle. EMS will be given at quadricep muscles. The pads will placed vertically in the midline along the knee and the pelvis. EMS will be given at frequency = 35 to 70 Hz, pulse duration = 100 µs, pulse period = 50 ms, Intervention will be will be performed for 60 minutes for 3 times or week for 4 weeks. Conversely, the endurance training phase will involve securing the cycle seat while children cycle at their maximum capacity, aiming for a heart rate between 70% to 80% of their maximum. Prior to and following each session, stretching exercises targeting the calf, quadricep, and hamstring muscles will be administered, with a 10-second hold during both the warm-up and cool-down sessions. Pre and post measurements will be conducted to evaluate mobility and gait
• PEDAL
In Group B, participants will exclusively receive the Pediatric Endurance and Limb Strengthening program without EMS. Similar to Group A, this program will incorporate the use of a stationary cycle. The warm-up and cool-down periods will also include a 10-second hold for each targeted muscle group. The intervention will consist of 60-minute sessions conducted three times per week over a span of four weeks. Pre and post-assessments of gait and mobility will be conducted using the Gait Outcomes Assessment List (GOALTM) Questionnaire and the time up and go test.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

References & Publications (1)

Vitrikas K, Dalton H, Breish D. Cerebral Palsy: An Overview. Am Fam Physician. 2020 Feb 15;101(4):213-220. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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