Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407869
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-06
Brief Title:
Effects of Functional Progressive Strength Training in Children With Spastic Cerebral Palsy
Sponsor:
Riphah International University
Organization:
Riphah International University
Study Overview
Official Title:
Effects of Functional Progressive Strength Training on Gait Parameters and Walking Capacity in Children With Spastic 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:
This study focuses on the effects of Functional Progressive Strength Training FPST on children with spastic cerebral palsy a condition characterized by increased muscle tone that affects movement Spastic cerebral palsy is one type of cerebral palsy with others including dyskinetic which involves involuntary movements and ataxic which affects coordination FPST differs from traditional strength training by incorporating exercises that replicate everyday activities to integrate strength use in daily movements The study uses an experimental design with participants aged 6-12 years recruited from specialized centers They are randomly assigned to either a treatment group receiving FPST or a control group receiving standard care The study aims to measure improvements in gait and mobility assessed through various tools like step and stride length cadence and gait speed alongside caregiver reports and direct observations Statistical analyses will determine the effectiveness of FPST in enhancing motor function and walking capacity in these children
Detailed Description:
In the outlined study participants who fit the necessary inclusion and exclusion criteria are asked to provide written informed consent before taking part The randomization process involves each participant drawing a number from a box those who draw number one are placed in Group A experimental group while those drawing number two are placed in Group B control group
Group A undergoes a specialized treatment approach called Functional Progressive Resistance Exercise FPRE in addition to receiving conventional treatment The FPRE regimen starts with a three-minute warm-up that includes range of motion mobilization and stretching exercises This is followed by a series of resistance exercises such as sit-to-stand activities which increase in intensity over a six-week period targeting specific percentages of body weight The participants then engage in half-kneeling standing up and side-step-up exercises for 20 minutes each with rest intervals The session concludes with a two-minute cooldown The protocol is designed to gradually increase the load carried by the participants scaling up to five times then 10 times and eventually 15 times the initial weight with a minimum of one minute of rest between sets The exercises are calibrated through trial and error to find the maximum load that can be lifted for the defined number of repetitions and sets
Group B participants receive conventional physical therapy aimed at maintaining muscle flexibility and improving motor function Their routine includes an hour-long session three times a week consisting of stretching exercises focused on muscles prone to tightness such as the Achilles tendons hamstrings hip flexors and adductors Strength training targets specific muscle groups including hip flexors knee extensors and ankle dorsiflexors The gait training in Group B starts in a controlled environment such as walking between parallel bars and progresses to more complex tasks like walking unassisted in open spaces navigating different floor surfaces and moving through obstacle-laden paths
Both groups are reassessed after 12 weeks to evaluate the impact of their respective interventions on gait parameters and walking capacity using a combination of direct observation caregiver reports and standardized assessment tools The study aims to ascertain the relative efficacy of these two approaches in enhancing mobility and quality of life for children with spastic cerebral palsy
Group A undergoes a specialized treatment approach called Functional Progressive Resistance Exercise FPRE in addition to receiving conventional treatment The FPRE regimen starts with a three-minute warm-up that includes range of motion mobilization and stretching exercises This is followed by a series of resistance exercises such as sit-to-stand activities which increase in intensity over a six-week period targeting specific percentages of body weight The participants then engage in half-kneeling standing up and side-step-up exercises for 20 minutes each with rest intervals The session concludes with a two-minute cooldown The protocol is designed to gradually increase the load carried by the participants scaling up to five times then 10 times and eventually 15 times the initial weight with a minimum of one minute of rest between sets The exercises are calibrated through trial and error to find the maximum load that can be lifted for the defined number of repetitions and sets
Group B participants receive conventional physical therapy aimed at maintaining muscle flexibility and improving motor function Their routine includes an hour-long session three times a week consisting of stretching exercises focused on muscles prone to tightness such as the Achilles tendons hamstrings hip flexors and adductors Strength training targets specific muscle groups including hip flexors knee extensors and ankle dorsiflexors The gait training in Group B starts in a controlled environment such as walking between parallel bars and progresses to more complex tasks like walking unassisted in open spaces navigating different floor surfaces and moving through obstacle-laden paths
Both groups are reassessed after 12 weeks to evaluate the impact of their respective interventions on gait parameters and walking capacity using a combination of direct observation caregiver reports and standardized assessment tools The study aims to ascertain the relative efficacy of these two approaches in enhancing mobility and quality of life for children with spastic cerebral palsy
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