Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434246
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
Effect of Pully System on Hemiplegic Children
Sponsor:
Kafrelsheikh University
Organization:
Kafrelsheikh University
Study Overview
Official Title:
Effect of Pully System Exercise on Upper Limb Function in Hemiplegic Cerebral Palsy Children A Randomized Clinical Trials
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Introduction Cerebral palsy CP is a group of sensory motor and postural disorders caused by non-progressive brain injury in early development It can manifest in various forms including hemiplegia which affects about 21 to 40 of CP cases Upper extremity UE impairments in CP individuals are significant impacting daily activities and quality of life
Objective This study aims to investigate the effects of pulley system exercises on improving upper limb function in children with hemiplegic CP
Methods Design Randomized controlled double-blinded trial Participants 32 children aged 3-7 years with hemiplegic CP divided into intervention and control groups
Intervention The intervention group receives pulley system exercises plus standard care while the control group receives standard physical therapy
Duration Conducted between June 2024 and August 2024 Inclusion Criteria Diagnosed with hemiplegic CP aged 3-7 years able to follow instructions and with upper limb motor deficits
Exclusion Criteria Additional neurological disorders recent upper limb surgery previous rehabilitation programs severe medical conditions or contraindications to physical activity
Assessment Tools Assisting Hand Assessment AHA Bruininks-Oseretsky Test of Motor Proficiency BOT-2 Quality Upper Extremity Skills Test QUEST and Lafayette Manual Muscle Tester
Timing Baseline and after 3 months of intervention Treatment Intervention Group 45-60 minute sessions three times a week involving warm-up pulley system exercises and cool-down
Control Group Standard care physical therapy twice a week 45-60 minute sessions
Statistical Analysis Methods Descriptive statistics and Analysis of Covariance ANCOVA to analyze improvements in upper limb function
Significance Level p 005 Analysis Intention-to-treat to handle missing data This study aims to provide evidence on the effectiveness of pulley system exercises in enhancing upper limb function in children with hemiplegic CP potentially improving their independence and quality of life
Objective This study aims to investigate the effects of pulley system exercises on improving upper limb function in children with hemiplegic CP
Methods Design Randomized controlled double-blinded trial Participants 32 children aged 3-7 years with hemiplegic CP divided into intervention and control groups
Intervention The intervention group receives pulley system exercises plus standard care while the control group receives standard physical therapy
Duration Conducted between June 2024 and August 2024 Inclusion Criteria Diagnosed with hemiplegic CP aged 3-7 years able to follow instructions and with upper limb motor deficits
Exclusion Criteria Additional neurological disorders recent upper limb surgery previous rehabilitation programs severe medical conditions or contraindications to physical activity
Assessment Tools Assisting Hand Assessment AHA Bruininks-Oseretsky Test of Motor Proficiency BOT-2 Quality Upper Extremity Skills Test QUEST and Lafayette Manual Muscle Tester
Timing Baseline and after 3 months of intervention Treatment Intervention Group 45-60 minute sessions three times a week involving warm-up pulley system exercises and cool-down
Control Group Standard care physical therapy twice a week 45-60 minute sessions
Statistical Analysis Methods Descriptive statistics and Analysis of Covariance ANCOVA to analyze improvements in upper limb function
Significance Level p 005 Analysis Intention-to-treat to handle missing data This study aims to provide evidence on the effectiveness of pulley system exercises in enhancing upper limb function in children with hemiplegic CP potentially improving their independence and quality of life
Detailed Description:
Cerebral palsy CP is a collection of sensory and motor disorders as well as postural disorders caused by non-progressive injury to the immature brain12 It can be classified according to the topographical presentation as monoplegia hemiplegia diplegia and quadriplegia2 These obvious motor difficulties are frequently accompanied by cognitive disturbances and other neurologic difficulties3 CP is considered the most prevalent mobility disorder in children with an average frequency of 3 per 1000 live births worldwide and a high prevalence of 60 to 150 per 1000 among preterm infants who are born weighing less than 1500 g 4 Hemiplegic CP accounts for 21 to 40 of all cases of CP56
Impairments in the upper extremity UE are a major factor for activity limitation and participation restriction in individuals with CP and may affect up to 50 of CP subjects 7 UE limitations are mostly due to a lack of trunk control decrease in shoulder girdle motor control and imbalance between spastic and paretic muscles 8 That makes it difficult for people with CP to perform UE-specific tasks such as reaching grasping and manipulation and it leads to the significant involvement of the positioning and functioning of the elbows wrists and hands Moreover a lack of autonomy and dependence on other people may affect the individuals quality of life 9
Pulley therapy is a part of universal exercise unit which formed of spider cage and a system of pulley straps and weights for resistance It is a new method used for strengthening of weak muscles by isolating the target specific muscle for training 10 There are several benefits of pulley therapy as improving passiveactive ROM flexibility of muscle enhancing strength and endurance of muscle without any associated movement and improving functional skills and dynamic movement 11
So this study was conducted to investigate the effect of pully system exercise in improvement of upper limb function in hemiplegic cerebral palsy children
Subjects materials and methods
Randomized controlled double blinded study design was used The study will be conducted at El salam university out- patient clinic between June 2024 and August 2024 Subjects G power v2197 was used to calculate proper sample size based on pilot testing that revealed effect size of 105 the proposed sample size is 32 when using alpha of 005 and power of 80
The sample size will equal 32 randomly divided into two group study group will receive poly system exercise on upper limb Control group will receive designed physical therapy programme
Once participants meet the inclusion criteria and consent to participate they are randomly assigned to either the intervention group receiving pulley system exercises in addition to standard care or the control group receiving standard care Use a computer-generated random number table or software to assign participants
The therapists or researchers who conduct the evaluations eg AHA BOT-2 QUEST will not be informed of the participants group assignment This can be achieved by using different individuals to provide the intervention and assess the outcomes or by ensuring that assessment data are coded in such a way that the assessor does not know the group codes
Participants will be randomly assigned to one of two groups
Group A Intervention Group 16 Children will undergo a pulley system exercise regimen tailored to improve upper limb function in addition to designed physical therapy program for CP
Group B Control Group Children will receive designed physical therapy program for CP only
Impairments in the upper extremity UE are a major factor for activity limitation and participation restriction in individuals with CP and may affect up to 50 of CP subjects 7 UE limitations are mostly due to a lack of trunk control decrease in shoulder girdle motor control and imbalance between spastic and paretic muscles 8 That makes it difficult for people with CP to perform UE-specific tasks such as reaching grasping and manipulation and it leads to the significant involvement of the positioning and functioning of the elbows wrists and hands Moreover a lack of autonomy and dependence on other people may affect the individuals quality of life 9
Pulley therapy is a part of universal exercise unit which formed of spider cage and a system of pulley straps and weights for resistance It is a new method used for strengthening of weak muscles by isolating the target specific muscle for training 10 There are several benefits of pulley therapy as improving passiveactive ROM flexibility of muscle enhancing strength and endurance of muscle without any associated movement and improving functional skills and dynamic movement 11
So this study was conducted to investigate the effect of pully system exercise in improvement of upper limb function in hemiplegic cerebral palsy children
Subjects materials and methods
Randomized controlled double blinded study design was used The study will be conducted at El salam university out- patient clinic between June 2024 and August 2024 Subjects G power v2197 was used to calculate proper sample size based on pilot testing that revealed effect size of 105 the proposed sample size is 32 when using alpha of 005 and power of 80
The sample size will equal 32 randomly divided into two group study group will receive poly system exercise on upper limb Control group will receive designed physical therapy programme
Once participants meet the inclusion criteria and consent to participate they are randomly assigned to either the intervention group receiving pulley system exercises in addition to standard care or the control group receiving standard care Use a computer-generated random number table or software to assign participants
The therapists or researchers who conduct the evaluations eg AHA BOT-2 QUEST will not be informed of the participants group assignment This can be achieved by using different individuals to provide the intervention and assess the outcomes or by ensuring that assessment data are coded in such a way that the assessor does not know the group codes
Participants will be randomly assigned to one of two groups
Group A Intervention Group 16 Children will undergo a pulley system exercise regimen tailored to improve upper limb function in addition to designed physical therapy program for CP
Group B Control Group Children will receive designed physical therapy program for CP only
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