Cerebral PalsyNCT06460311
Effects of PEDAL Program With and Without EMS On Mobility And Gait In Children With Cerebral Palsy
A study testing PEDAL and EMS and PEDAL in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- PEDAL and EMS and PEDAL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2024to 25 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah international university
Lahore, Punjab Province, 540000
About this study
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
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- PEDAL and EMS, PEDAL
- Keywords
- cerebral palsy, electrical muscle stimulation, cycling, gait analysis, mobility, stationary cycle
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEDAL and EMSOther
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
PEDALOther
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 group | Role | What they receive |
|---|---|---|
| Group A | Experimental | PEDAL and EMS Receives: Other: PEDAL and EMS |
| Group B | Active comparator | PEDAL Receives: Other: PEDAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start15 Jun 2024
- Primary completion20 Aug 2024
- Study completion25 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabia Aslam, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460311
- Sponsor's protocol ID
- REC/RCR &AHS/23/0799
- Status last verified
- Oct 2024
- First submitted
- 11 Jun 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vitrikas K, Dalton H, Breish D. Cerebral Palsy: An Overview. Am Fam Physician. 2020 Feb 15;101(4):213-220.
PubMed 32053326
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06460311
- Acronym / sponsor ID
- REC/RCR &AHS/23/0799
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, electrical muscle stimulation, cycling, gait analysis, mobility, stationary cycle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: PEDAL and EMSPEDAL and EMS |
| Group B | Active comparator | Other: PEDALPEDAL |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEDAL and EMSGroup 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 | Other | Group A |
| PEDALIn 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. | Other | Group B |
Primary outcome
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 32053326Vitrikas K, Dalton H, Breish D. Cerebral Palsy: An Overview. Am Fam Physician. 2020 Feb 15;101(4):213-220.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabia Aslam, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEDAL and EMS and PEDAL in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selective Control Assessment of Lower Extremity (SCALE) (time frame: 8 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06460311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.