Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460311
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-11
Brief Title:
Effects of PEDAL Program With and Without EMS On Mobility And Gait In Children With Cerebral Palsy
Sponsor:
Riphah International University
Organization:
Riphah International University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Group A PEDALEMS 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None