Cerebral PalsyFPTCPNCT06748183
Functional Power Training on Mobility and Gait Parameters in Cerebral Palsy
A study testing Functional Power Training and Routine physical therapy in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral Palsy is a lifelong neuromuscular disorder impacting movement, posture, and muscle control, ranging from mild hand weakness to severe paralysis. Risk factors are grouped into specific stages: preconception (linked to the mother's health), prenatal (during pregnancy), perinatal (at birth), and the neonatal and… 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?
- Functional Power Training and Routine physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Sep 2024to 15 Jan 2025
- 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 6 to 12
- Gross Motor Function Classification System (GMFCS) I and II
- Either gender will be included
Who cannot join
- Treatment with botulinum toxin A in lower limb
- Serial Casting of lower limb less than 6 months before the start of the functional power training
- Selective dorsal rhizotomy treatment
- Children who did not (yet) choose walking as their preferred way of mobility
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Functional Power Training on Mobility and Gait Parameters in Children With Cerebral Palsy.
Cerebral Palsy is a lifelong neuromuscular disorder impacting movement, posture, and muscle control, ranging from mild hand weakness to severe paralysis. Risk factors are grouped into specific stages: preconception (linked to the mother's health), prenatal (during pregnancy), perinatal (at birth), and the neonatal and infant stages. Functional power training is employed to improve the functional abilities of children with Cerebral Palsy by involving them in various power-based exercises to strengthen muscles, increase power, and build endurance. This study aims to evaluate the impact of functional power training on gait and mobility in children with Cerebral Palsy.
Read the detailed description
Cerebral Palsy (CP) is a chronic neuromuscular disorder that affects movement, posture, and muscle control, with symptoms ranging from mild weakness to severe paralysis. The risk factors for CP are classified into preconception, prenatal, perinatal, and neonatal categories. Functional power training (FPT) is a therapeutic approach aimed at improving muscle strength, power, and endurance in children with CP. This study seeks to evaluate the impact of FPT on gait parameters and mobility in children with CP. This randomized controlled trial will include 26 children, aged 6 to 12 years, with Gross Motor Function Classification System (GMFCS) I or II. Participants will be randomly assigned to either the experimental group (FPT plus routine physical therapy) or the control group (routine physical therapy alone). Exclusion criteria include recent botulinum toxin A treatment, serial casting within the last 6 months, or selective dorsal rhizotomy. Gait parameters (step length, stride length, cadence, gait speed, and step width) and mobility outcomes (6MWT and Timed Up and Go test) will be assessed before and after the intervention. Data will be analyzed using SPSS version 23.
- Conditions
- Cerebral Palsy
- Being tested
- Functional Power Training, Routine physical therapy
- Keywords
- Cerebral Palsy, Gait Parameters, Mobility, Functional Power Training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Power TrainingOther
Group A will participate in Functional Power Training (FPT) alongside routine physical therapy The exercise protocol aims to enhance strength, mobility, and endurance through resistance training across various functional activities. It includes exercises such as running, walking, chair pushing, stair climbing, propelling a stable scooter, and sideways walking, all performed at 50-70% of the participant's maximum speed. Resistance is added using methods like dragging a loaded box with a belt during running and walking, pushing a chair with a loaded box underneath, wearing a loaded vest while climbing stairs, and attaching a loaded box to a scooter for propulsion exercises. Each exercise involves 6 to 8 repetitions lasting 25 seconds, followed by 30 to 50 seconds of rest. This structured regimen focuses on controlled movement and endurance, providing a comprehensive approach to improving physical performance.
Routine physical therapyOther
Routine physical therapy for a child with Cerebral Palsy involves hot pack for muscle relaxation and isometric exercises to enhance motor skills, muscle strength, and coordination. Passive stretching will be given as a treatment plan. Therapists employ sit to stand exercise to improve gait, posture, and overall functional abilities. Regular progress evaluations are conducted to adjust interventions, ensuring ongoing improvements.
| Study group | Role | What they receive |
|---|---|---|
| Functional Power Training | Experimental | Group A will participate in Functional Power Training (FPT) alongside routine physical therapy for children with Cerebral Palsy. The standard therapy includes hot packs for muscle relaxation, isometric exercises for motor skills, muscle strength, and coordination, as well as passive stretching. Therapists will also utilize sit-to-stand exercises to enhance gait and overall functional abilities. Over a 14-week intervention period, FPT will include three 60-minute sessions each week, focusing on improving walking capacity and muscle strength. Each session will consist of a 10-minute warm-up, 35 minutes of 3 to 4 power exercises, and a 15-minute cool-down phase, conducted in small groups of 3-6 children with a supervising therapist. Participants will wear sports shoes without orthoses, and power exercises will target functional, multi-joint movements, emphasizing ankle push-off and velocity, with adjustments made for progressive challenges. Receives: Other: Functional Power Training |
| Routine Physical therapy | Other | Routine physical therapy for children with Cerebral Palsy includes hot packs for muscle relaxation and isometric exercises aimed at improving motor skills, muscle strength, and coordination. Passive stretching is also part of the treatment plan. Therapists use sit-to-stand exercises to enhance gait, posture, and overall functional abilities. Regular progress evaluations are conducted to adjust interventions as needed, ensuring continuous improvement. The overall goal is to optimize mobility, enhance walking ability, and improve the child's quality of life. Receives: Other: Routine physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step length
To measure step length(centimeters), first mark a starting point on the floor, then have the participant walk naturally while measuring the distance between consecutive heel strikes. Repeat this process for several steps and calculate the average of those measurements to determine the participant's typical step length.
Measured: 5 months
Stride length
To measure stride length(meters) first identify the starting point on the walking path and instruct the participant to take several steps. Then, measure the distance between two consecutive heel strikes of the same foot, repeat for multiple strides, and calculate the average to determine the participant's typical stride length.
Measured: 5 months
Cadence
To measure cadence(steps/min), choose a specific time interval and instruct the participant to walk within that period while counting the number of steps taken. Repeat the process for accuracy and calculate the average steps per minute to determine the participant's cadence.
Measured: 5 months
Gate speed
To measure gait speed(meters/sec), mark the starting and finishing points on a straight path, and instruct the participant to walk at a comfortable pace while measuring the time taken to cover the distance. Repeat the process for accuracy, then calculate gait speed by dividing the distance by the time taken to complete it.
Measured: 5 months
Step width
To measure step width(centimeter), define a walking path and instruct the participant to walk naturally while measuring the lateral distance between the midpoints of successive footsteps. Repeat this measurement for multiple steps and calculate the average step width to analyze the participant's walking pattern.
Measured: 5 months
Secondary outcomes (2)
6-Minute Walk Test
Set up a marked straight pathway and instruct the individual to walk as far as possible within a 6-minute timeframe, encouraging them to maintain a consistent pace while providing periodic time updates. At the end of the session, measure the total distance covered in meters to assess their functional capacity
Measured: 5 months
Timed up and go (TUG) test
Start with the individual seated in a chair, and upon the signal, have them stand, walk three meters, turn, walk back, and sit down. Measure the total time taken for this sequence to assess functional mobility, with longer times suggesting potential mobility challenges.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start26 Sep 2024
- Primary completion1 Jan 2025
- Study completion15 Jan 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It will be a randomized control trial employing nonprobability convenient sampling. Two groups, comprising participants aged 6 to 12, will be formed and randomly divided. Group A will undergo Functional Power Training (FPT) alongside Routine Physical Therapy (RPT), while Group B will receive only Routine Physical Therapy (RPT). This intervention aims to compare the effects of combined functional training and routine therapy against routine therapy alone, focusing on improvements in gait parameters and mobility among children with Cerebral Palsy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asiah Fareed, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748183
- Sponsor's protocol ID
- REC/RCR&AHS/0706
- Acronym
- FPTCP
- Status last verified
- Jan 2025
- First submitted
- 3 Nov 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Vulpen LF, de Groot S, Rameckers E, Becher JG, Dallmeijer AJ. Improved Walking Capacity and Muscle Strength After Functional Power-Training in Young Children With Cerebral Palsy. Neurorehabil Neural Repair. 2017 Sep;31(9):827-841. doi: 10.1177/1545968317723750. Epub 2017 Aug 8.
PubMed 28786309
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Power Training on Mobility and Gait Parameters in Children With Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT06748183
- Acronym / sponsor ID
- FPTCP / REC/RCR&AHS/0706
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Gait Parameters, Mobility, Functional Power Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 27 Dec 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.
Cerebral Palsy is a lifelong neuromuscular disorder impacting movement, posture, and muscle control, ranging from mild hand weakness to severe paralysis. Risk factors are grouped into specific stages: preconception (linked to the mother's health), prenatal (during pregnancy), perinatal (at birth), and the neonatal and infant stages. Functional power training is employed to improve the functional abilities of children with Cerebral Palsy by involving them in various power-based exercises to strengthen muscles, increase power, and build endurance. This study aims to evaluate the impact of functional power training on gait and mobility in children with Cerebral Palsy.
Detailed description
Cerebral Palsy (CP) is a chronic neuromuscular disorder that affects movement, posture, and muscle control, with symptoms ranging from mild weakness to severe paralysis. The risk factors for CP are classified into preconception, prenatal, perinatal, and neonatal categories. Functional power training (FPT) is a therapeutic approach aimed at improving muscle strength, power, and endurance in children with CP. This study seeks to evaluate the impact of FPT on gait parameters and mobility in children with CP. This randomized controlled trial will include 26 children, aged 6 to 12 years, with Gross Motor Function Classification System (GMFCS) I or II. Participants will be randomly assigned to either the experimental group (FPT plus routine physical therapy) or the control group (routine physical therapy alone). Exclusion criteria include recent botulinum toxin A treatment, serial casting within the last 6 months, or selective dorsal rhizotomy. Gait parameters (step length, stride length, cadence, gait speed, and step width) and mobility outcomes (6MWT and Timed Up and Go test) will be assessed before and after the intervention. Data will be analyzed using SPSS version 23.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It will be a randomized control trial employing nonprobability convenient sampling. Two groups, comprising participants aged 6 to 12, will be formed and randomly divided. Group A will undergo Functional Power Training (FPT) alongside Routine Physical Therapy (RPT), while Group B will receive only Routine Physical Therapy (RPT). This intervention aims to compare the effects of combined functional training and routine therapy against routine therapy alone, focusing on improvements in gait parameters and mobility among children with Cerebral Palsy.
| Arm | Type | Receives |
|---|---|---|
| Functional Power Training | Experimental | Other: Functional Power TrainingGroup A will participate in Functional Power Training (FPT) alongside routine physical therapy for children with Cerebral Palsy. The standard therapy includes hot packs for muscle relaxation, isometric exercises for motor skills, muscle strength, and coordination, as well as passive stretching. Therapists will also utilize sit-to-stand exercises to enhance gait and overall functional abilities. Over a 14-week intervention period, FPT will include three 60-minute sessions each week, focusing on improving walking capacity and muscle strength. Each session will consist of a 10-minute warm-up, 35 minutes of 3 to 4 power exercises, and a 15-minute cool-down phase, conducted in small groups of 3-6 children with a supervising therapist. Participants will wear sports shoes without orthoses, and power exercises will target functional, multi-joint movements, emphasizing ankle push-off and velocity, with adjustments made for progressive challenges. |
| Routine Physical therapy | Other | Other: Routine physical therapyRoutine physical therapy for children with Cerebral Palsy includes hot packs for muscle relaxation and isometric exercises aimed at improving motor skills, muscle strength, and coordination. Passive stretching is also part of the treatment plan. Therapists use sit-to-stand exercises to enhance gait, posture, and overall functional abilities. Regular progress evaluations are conducted to adjust interventions as needed, ensuring continuous improvement. The overall goal is to optimize mobility, enhance walking ability, and improve the child's quality of life. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 6 to 12
- Gross Motor Function Classification System (GMFCS) I and II
- Either gender will be included
Key exclusion criteria (4 listed)
- Treatment with botulinum toxin A in lower limb
- Serial Casting of lower limb less than 6 months before the start of the functional power training
- Selective dorsal rhizotomy treatment
- Children who did not (yet) choose walking as their preferred way of mobility
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 |
|---|---|---|
| Functional Power TrainingGroup A will participate in Functional Power Training (FPT) alongside routine physical therapy The exercise protocol aims to enhance strength, mobility, and endurance through resistance training across various functional activities. It includes exercises such as running, walking, chair pushing, stair climbing, propelling a stable scooter, and sideways walking, all performed at 50-70% of the participant's maximum speed. Resistance is added using methods like dragging a loaded box with a belt during running and walking, pushing a chair with a loaded box underneath, wearing a loaded vest while climbing stairs, and attaching a loaded box to a scooter for propulsion exercises. Each exercise involves 6 to 8 repetitions lasting 25 seconds, followed by 30 to 50 seconds of rest. This structured regimen focuses on controlled movement and endurance, providing a comprehensive approach to improving physical performance. | Other | Functional Power Training |
| Routine physical therapyRoutine physical therapy for a child with Cerebral Palsy involves hot pack for muscle relaxation and isometric exercises to enhance motor skills, muscle strength, and coordination. Passive stretching will be given as a treatment plan. Therapists employ sit to stand exercise to improve gait, posture, and overall functional abilities. Regular progress evaluations are conducted to adjust interventions, ensuring ongoing improvements. | Other | Routine Physical therapy |
Primary outcome
Step length
Time frame: 5 months
To measure step length(centimeters), first mark a starting point on the floor, then have the participant walk naturally while measuring the distance between consecutive heel strikes. Repeat this process for several steps and calculate the average of those measurements to determine the participant's typical step length.
Stride length
Time frame: 5 months
To measure stride length(meters) first identify the starting point on the walking path and instruct the participant to take several steps. Then, measure the distance between two consecutive heel strikes of the same foot, repeat for multiple strides, and calculate the average to determine the participant's typical stride length.
Cadence
Time frame: 5 months
To measure cadence(steps/min), choose a specific time interval and instruct the participant to walk within that period while counting the number of steps taken. Repeat the process for accuracy and calculate the average steps per minute to determine the participant's cadence.
Gate speed
Time frame: 5 months
To measure gait speed(meters/sec), mark the starting and finishing points on a straight path, and instruct the participant to walk at a comfortable pace while measuring the time taken to cover the distance. Repeat the process for accuracy, then calculate gait speed by dividing the distance by the time taken to complete it.
Step width
Time frame: 5 months
To measure step width(centimeter), define a walking path and instruct the participant to walk naturally while measuring the lateral distance between the midpoints of successive footsteps. Repeat this measurement for multiple steps and calculate the average step width to analyze the participant's walking pattern.
2 secondary outcomes
6-Minute Walk Test
Time frame: 5 months
Timed up and go (TUG) test
Time frame: 5 months
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 23 Jan 2025.
- Background: PubMed 28786309van Vulpen LF, de Groot S, Rameckers E, Becher JG, Dallmeijer AJ. Improved Walking Capacity and Muscle Strength After Functional Power-Training in Young Children With Cerebral Palsy. Neurorehabil Neural Repair. 2017 Sep;31(9):827-841. doi: 10.1177/1545968317723750. Epub 2017 Aug 8.
- 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.
Asiah Fareed, 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 Functional Power Training and Routine physical therapy 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 3 inclusion and 4 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 23 Jan 2025. 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?
Step length (time frame: 5 months). The study lists 5 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 NCT06748183, 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 23 Jan 2025.