Clinical trial NCT05896111: Whole Body Vibration for Hemiparetic Cerebral Palsy
Official title: Effect of Whole Body Vibration on Upper Limb Range of Motion and Strength in Children With Hemiparetic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Therapy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot testing to get sample.
Primary purpose: TREATMENT

Brief summary: This study is to investigate the effect of whole body vibration in children with hemiparetic cerebral palsy on range of motion of shoulder, elbow and wrist and muscle strength of shoulder abductors and flexors, elbow flexors and extensors, wrist extensors and flexors.

Detailed description: Studies show efficacy of whole body vibration in reducing spasticity, improving strength, balance, ankle dorsiflexion angle and gait parameters in post stroke and spinal cord injury patients improving posture and balance in patients with Parkinson's disease and multiple sclerosis. Although research suggests a positive influence of vibration on motor performance in individuals with neurological disorders, there are very limited numbers of studies in children with cerebral palsy.

Few Studies Have Shown improvement in children with cerebral palsy: spasticity decrease as measured by isokinetic dynamometer. Strength of muscles increase as measured by hand held dynamometer. Motor function increase as measured by Gross Motor Function Measure and Gross Motor Function Classification Scale. Increase of the activation and the co- activation of biceps and triceps. Vibrations increase bone mass and muscle strength in upper limbs.

Vibration therapy decreases spasticity and improve motor performance in children with cerebral palsy. Reduce flexors spasticity and improve functions in the rehabilitation of upper limb spasticity. Focal muscle vibration on triceps brachii muscle can reduce the spasticity for both elbow and wrist joint muscles.

So in this study, the investigators are trying to implement an additional rehabilitation method for upper limbs in hemiparetic children to improve their upper limb range of motion and strength which will reflect an improvement in their upper limb functions and activities of daily living.

Eligibility criteria: Inclusion criteria:

Children will be included if they have the following:

1. Children diagnosed as hemiparetic cerebral palsy.
2. Children of both sexes in the age group ranging from 3 to 6 years.
3. Spasticity will be grade 1 and 1+ according to modified Ashworth scale.
4. They will be selected with Level I and II according to Gross Motor Function Classification (GMFCS).
5. Children could understand and follow commands given by the therapist.

Exclusion criteria:

Children will be excluded if they have any of the following:

1. History of convulsions and epilepsy.
2. Children with impaired cognitive function.
3. Any surgical procedure for correction of deformity or soft tissue release in the past one year.

Primary outcomes:
measure: Change in shoulder joint abduction range of motion.
timeFrame: Change from Baseline shoulder joint abduction range of motion at one month.
measure: Change in shoulder joint flexion range of motion.
timeFrame: Change from Baseline shoulder joint flexion range of motion at one month.
measure: Change in elbow joint flexion range of motion.
timeFrame: Change from Baseline elbow joint flexion range of motion at one month.
measure: Change in elbow joint extension range of motion.
timeFrame: Change from Baseline elbow joint extension range of motion at one month.
measure: Change in wrist joint extension range of motion.
timeFrame: Change from Baseline wrist joint extension range of motion at one month.
measure: Change in wrist joint flexion range of motion.
timeFrame: Change from Baseline wrist joint flexion range of motion at one month.
measure: Change in strength of shoulder abductors muscles.
timeFrame: Change from Baseline strength of shoulder abductors muscles at one month.
measure: Change in strength of shoulder flexors muscles.
timeFrame: Change from Baseline strength of shoulder flexors muscles at one month.
measure: Change in strength of elbow flexors muscles.
timeFrame: Change from Baseline strength of elbow flexors muscles at one month.
measure: Change in strength of elbow extensors muscles.
timeFrame: Change from Baseline strength of elbow extensors muscles at one month.
measure: Change in strength of wrist extensors muscles.
timeFrame: Change from Baseline strength of wrist extensors muscles at one month.
measure: Change in strength of wrist flexors muscles.
timeFrame: Change from Baseline strength of wrist flexors muscles at one month.
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ministry of Health
Study officials:
affiliation: Cairo University
name: Haytham Morsi, M.Sc.
role: STUDY_DIRECTOR
References: