Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06332729
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2024-03-15
Brief Title:
Universal Exercise Unit Versus Functional Electrical Stimulation On Genu Recurvatum In Diplegic Cerebral Palsy
Sponsor:
Mahmoud Reda Elsharkawy
Organization:
Kafrelsheikh University
Study Overview
Official Title:
Effect of Universal Exercise Unit Versus Functional Electrical Stimulation On Genu Recurvatum In Diplegic Cerebral Palsy Children
Status:
COMPLETED
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:
Summary
Inclusion Criteria
Children aged four to eight years
Grade of spasticity ranging from 1 to 1 on the Modified Ashworth scale
Classified as Level I or II on the Gross Motor Functional Classification System GMFCS
Ability to follow verbal commands and instructions
Exclusion Criteria
Previous neurological or orthopedic surgery in the lower extremities
Botox injection in the lower extremities within the past six months
Fixed deformity in the joints of the lower limb
Genu recarvatum secondary to surgery
Severe hearing and visual defects
Materials for Subject Selection and Evaluation
Modified Ashworth Scale for muscle tone assessment
Gross Motor Functional Classification System GMFCS for functional activity classification
Digital goniometer for measuring the angle of knee hyperextension
Lafayette Manual Muscle Tester for quantifying muscle strength
Methods
Assessment of muscle tone using the Modified Ashworth Scale evaluating spasticity in calf muscles and hipknee extensors
Evaluation of gross motor function using the GMFCS
Assessment of genu recarvatum using a digital goniometer
Assessment of muscle strength using the Lafayette Manual Muscle Tester focusing on hamstrings and tibialis anterior muscles
Assessment of range of motion in the knee joint using Kinovea software
Treatment procedures involving physical therapy sessions with a combination of exercises and interventions tailored to each group Group A and Group B
Group A Treatment
- Designed physical therapy program combined with pulley therapy for muscle strengthening
Group B Treatment
- Designed physical therapy program combined with functional electrical stimulation during walking on a treadmill for muscle stimulation
The interventions in both groups aim to improve muscle strength range of motion and functional abilities in children with cerebral palsy
Inclusion Criteria
Children aged four to eight years
Grade of spasticity ranging from 1 to 1 on the Modified Ashworth scale
Classified as Level I or II on the Gross Motor Functional Classification System GMFCS
Ability to follow verbal commands and instructions
Exclusion Criteria
Previous neurological or orthopedic surgery in the lower extremities
Botox injection in the lower extremities within the past six months
Fixed deformity in the joints of the lower limb
Genu recarvatum secondary to surgery
Severe hearing and visual defects
Materials for Subject Selection and Evaluation
Modified Ashworth Scale for muscle tone assessment
Gross Motor Functional Classification System GMFCS for functional activity classification
Digital goniometer for measuring the angle of knee hyperextension
Lafayette Manual Muscle Tester for quantifying muscle strength
Methods
Assessment of muscle tone using the Modified Ashworth Scale evaluating spasticity in calf muscles and hipknee extensors
Evaluation of gross motor function using the GMFCS
Assessment of genu recarvatum using a digital goniometer
Assessment of muscle strength using the Lafayette Manual Muscle Tester focusing on hamstrings and tibialis anterior muscles
Assessment of range of motion in the knee joint using Kinovea software
Treatment procedures involving physical therapy sessions with a combination of exercises and interventions tailored to each group Group A and Group B
Group A Treatment
- Designed physical therapy program combined with pulley therapy for muscle strengthening
Group B Treatment
- Designed physical therapy program combined with functional electrical stimulation during walking on a treadmill for muscle stimulation
The interventions in both groups aim to improve muscle strength range of motion and functional abilities in children with cerebral palsy
Detailed Description:
BFor assessment
1 Assessment of muscle strength
In this study Lafayette manual muscle tester device will be used to assess muscle strength of hamstrings and tibialis anterior muscles
Test procedures will be demonstrated to each child
For both tests each child will perform three corrected trials and the average will be taken in analysis
For tibialis anterior muscle
Each child will be lied supine with feet relaxed on the plinth Hips knees will be in extension and neutral rotation Each child will be stabilized by straps at pelvis and just above knees then the examiner will place the device in his hand and put it on the dorsum aspect of examined foot over the metatarsal heads and ask the child to take hisher foot toward him the device
For hamstrings muscle
Each child will be seated with hips and knees flexed 90 Each child will be stabilized at trunk pelvis and unexamined limb by straps to prevent any substitutions The examined limb will be stabilized above examiner hand and in the other hand Lafayette device will be placed The device will be placed on the posterior lower part of the examined leg then the examiner will ask the child to move hisher lower leg backward against device
2 Assessment of range of motion in knee joint
Using kinovea Kinovea is a free 2D motion analysis software that enables the establishment of kinematics parameters This low-cost technology has been used in sports sciences as well as clinical field and research work Kinovea is a free reliable tool that produces valid data providing an acceptable level of accuracy in angular and linear measurements obtained via digitization of x- and y axis coordinates -Treatment procedures - Each child of both group AB received a designed physical therapy program attending three sessions per week for three consecutive months The program used a combination of open-and closed-chain exercises Exercises for facilitating standing and balance as kneeling and half kneeling exercises step standing single limb support from supine to stand from prone to stand and standing on balance board abdominal and core stability exercise on wedge exercises for strengthening of hamstring and tibialis anterior muscles by using free weights and gait training including walking in stepper between parallel bars and ascending and descending stairs for one hour
1 Group A Each child in the group A received the designed program physical therapy in addition to pulley therapy attending three sessions per week for three consecutive months The duration of the session was one hour that was divided into half an hour for the designed physical therapy program and half an hour for the pull therapy The pulley therapy is used to strength hamstring and tibialis anterior muscles The weight used in training is determined by using the one repetition maximum method I-RM The 1-RM was taken as the maximum resistance that could be lifted throughout the full ROM To assess 1-RM estimate the starting weight to be a little bit less than the childs maximum capacity for lifting Then for exercises weight increased gradually in each attempt till the child reached maximum lifting capacity The added weight ranged from 1 to 5 kg according to the evaluated muscle group With periods of rest from 1 to 5 minutes allowed before attempting a lift at the next heavier weight Children performed a mild to moderate load about 60 1-RM for 1 to 2 sets with 8-15 repetitions For hamstring muscle each child lied prone on the table inside spider cage The child stabilized by straps at pelvis and unaffected limb The affected limb was stabilized at thigh level with lower leg free to move A band around lower leg attached to upper part of the cage by a rope at foot side At the end of the rope there was a weight to pull Each child was asked to pull his leg toward him against weight doing one set of 10 repetitions at first up to 1-2 sets of 8-15 repetitions
For tibialis anterior each child lied supine on the table inside spider cage The child stabilized by straps at pelvis and unaffected limb The affected limb was stabilized by straps at thigh and lower leg with foot free to move A band around foot attached to upper part of the cage by a rope at foot side At the end of the rope there was a weight to pull Each child was asked to pull his foot toward him against weight doing one set of 10 repetitions up to 1-2 sets of 8-15 repetitions for 20 minutes
2 Group B Each child in group B receive the designed program plus the functional electrical stimulation for 30minutes on hamstring muscle and tibalis anterior muscle during walking on tread-mail with the following parameters - Pulse frequency 25-40 HZ pulse duration 250 to 300 msec with on off time 12 for 20 minutes electrodes will attach to peroneal at the back of the fibular head and the tibalis anterior muscle 5 cm below the fibular head and then adjust to create ankle dorsiflexion with avoiding the inversion
A pair of electrodes stimulated the hamstring muscle near the motor on the motor point on both muscle of bices femoris semitendinosus and semimembranosus with avoiding the rotation
1 Assessment of muscle strength
In this study Lafayette manual muscle tester device will be used to assess muscle strength of hamstrings and tibialis anterior muscles
Test procedures will be demonstrated to each child
For both tests each child will perform three corrected trials and the average will be taken in analysis
For tibialis anterior muscle
Each child will be lied supine with feet relaxed on the plinth Hips knees will be in extension and neutral rotation Each child will be stabilized by straps at pelvis and just above knees then the examiner will place the device in his hand and put it on the dorsum aspect of examined foot over the metatarsal heads and ask the child to take hisher foot toward him the device
For hamstrings muscle
Each child will be seated with hips and knees flexed 90 Each child will be stabilized at trunk pelvis and unexamined limb by straps to prevent any substitutions The examined limb will be stabilized above examiner hand and in the other hand Lafayette device will be placed The device will be placed on the posterior lower part of the examined leg then the examiner will ask the child to move hisher lower leg backward against device
2 Assessment of range of motion in knee joint
Using kinovea Kinovea is a free 2D motion analysis software that enables the establishment of kinematics parameters This low-cost technology has been used in sports sciences as well as clinical field and research work Kinovea is a free reliable tool that produces valid data providing an acceptable level of accuracy in angular and linear measurements obtained via digitization of x- and y axis coordinates -Treatment procedures - Each child of both group AB received a designed physical therapy program attending three sessions per week for three consecutive months The program used a combination of open-and closed-chain exercises Exercises for facilitating standing and balance as kneeling and half kneeling exercises step standing single limb support from supine to stand from prone to stand and standing on balance board abdominal and core stability exercise on wedge exercises for strengthening of hamstring and tibialis anterior muscles by using free weights and gait training including walking in stepper between parallel bars and ascending and descending stairs for one hour
1 Group A Each child in the group A received the designed program physical therapy in addition to pulley therapy attending three sessions per week for three consecutive months The duration of the session was one hour that was divided into half an hour for the designed physical therapy program and half an hour for the pull therapy The pulley therapy is used to strength hamstring and tibialis anterior muscles The weight used in training is determined by using the one repetition maximum method I-RM The 1-RM was taken as the maximum resistance that could be lifted throughout the full ROM To assess 1-RM estimate the starting weight to be a little bit less than the childs maximum capacity for lifting Then for exercises weight increased gradually in each attempt till the child reached maximum lifting capacity The added weight ranged from 1 to 5 kg according to the evaluated muscle group With periods of rest from 1 to 5 minutes allowed before attempting a lift at the next heavier weight Children performed a mild to moderate load about 60 1-RM for 1 to 2 sets with 8-15 repetitions For hamstring muscle each child lied prone on the table inside spider cage The child stabilized by straps at pelvis and unaffected limb The affected limb was stabilized at thigh level with lower leg free to move A band around lower leg attached to upper part of the cage by a rope at foot side At the end of the rope there was a weight to pull Each child was asked to pull his leg toward him against weight doing one set of 10 repetitions at first up to 1-2 sets of 8-15 repetitions
For tibialis anterior each child lied supine on the table inside spider cage The child stabilized by straps at pelvis and unaffected limb The affected limb was stabilized by straps at thigh and lower leg with foot free to move A band around foot attached to upper part of the cage by a rope at foot side At the end of the rope there was a weight to pull Each child was asked to pull his foot toward him against weight doing one set of 10 repetitions up to 1-2 sets of 8-15 repetitions for 20 minutes
2 Group B Each child in group B receive the designed program plus the functional electrical stimulation for 30minutes on hamstring muscle and tibalis anterior muscle during walking on tread-mail with the following parameters - Pulse frequency 25-40 HZ pulse duration 250 to 300 msec with on off time 12 for 20 minutes electrodes will attach to peroneal at the back of the fibular head and the tibalis anterior muscle 5 cm below the fibular head and then adjust to create ankle dorsiflexion with avoiding the inversion
A pair of electrodes stimulated the hamstring muscle near the motor on the motor point on both muscle of bices femoris semitendinosus and semimembranosus with avoiding the rotation
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