Effects of PEDAL Program With and Without EMS On Mobility And Gait In Children With Cerebral Palsy
Effects Of Pediatric Endurance And Limb Strengthening (PEDAL) Program With And Without Electrical Muscle Stimulation On Mobility And Gait In Children With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 540000
- Riphah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
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 |
|
Active Comparator: Group B
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Selective Control Assessment of Lower Extremity (SCALE)
Time Frame: 8 Weeks
|
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 Frame: 8 Weeks
|
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
Time Frame: 8 Weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rabia Aslam, MS*, Riphah International University
Publications and helpful links
General Publications
- 1. Vitrikas K, Dalton H, Breish D. Cerebral palsy: an overview. American family physician. 2020;101(4):213-20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR &AHS/23/0799
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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