Clinical trial NCT04789629: Effect of Low Level Laser Therapy on Hamstring Muscle Tightness and Calf Muscle Spasticity in Cerebral Palsy Children.
Official title: Effect of Low Level Laser Therapy on Hamstring Muscle Tightness and Calf Muscle Spasticity in Cerebral Palsy Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: low level laser
spasticity
cerebral palsy
Lead sponsor: National Institute of Laser Enhanced Sciences
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomize clinical trail
Primary purpose: TREATMENT

Brief summary: Background :Spasticity is a motor disorder in children with cerebral palsy (CP) Cp is a non progress lesion in unmature brain lead to a group of chronic disorders that affect movement and posture development, may be accompanied by epilepsy, secondary musculoskeletal problems, deformaties and disturbances of sensation, perception, cognition, communication, and behavior Few studies demonstrate effectiveness of laser therapies in spasticity in cp.

Methodology : This study is randomize control trail aimes to evaluate the effect of low-level laser therapy (LLLT) on the spasticity of hamstring and calf muscle in children with CP over 12 session of intermittent laser exposures. Muscle tone , gross motor function, rang of motion (rom ) and poplital angle will evaluate before and after laser irradiation in 30 children with CP both geneder aged between two to six years old diaplegic clidren , exclusion children who take botox or done surgery . Muscles will irradiated with low-intensity diode laser pulses of 808-nm wavelength three times per week over one month follow up for one month.

Detailed description: This is a randomized controlled study, in which the 30 children with diaplegic randomly divide into control and study groups by excel sheat on computer, each group include 15child. Each child will receive laser at a frequency of three sessions per week for 12 session, in addition to conventional physiotherapy program, while the control group have 15 child will receive conventional physiotherapy. Four variables will choose to detect the effect of laser therapy: (1) muscle tone, (2) range of motion (ROM) , (3) gross movement,(4) poplital angle assessment . These values will recorde in both groups before starting treatment and after the treatment period and after one month of stop treatment .

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Eligibility criteria: Inclusion Criteria:

* spastic diaplegic children aged between 2 to 6years have spastic hamstring and calf muscle .

Exclusion Criteria:

* for post-operative children , children who take botox, children with contracture or fixed deformity

Primary outcomes:
measure: Modified Ashworth scale
timeFrame: one month of treatment
measure: Modified Ashworth scale
timeFrame: 2 months
measure: rom by Goniometer
timeFrame: one month of treatment
measure: rom by Goniometer
timeFrame: 2 months
measure: poplital angle test
timeFrame: one month of treatment
measure: poplital angle test
timeFrame: 2 months
Secondary outcomes:
measure: gross motor
timeFrame: one month of treatment
measure: gross motor
timeFrame: 2 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Out Clinic of Physical Therapy Faculty
state: El Dokki
Study officials:
affiliation: NILES
name: osama mr fekery, prof
role: STUDY_CHAIR
affiliation: physical therapy faculty
name: asmaa ms osama, assist prof
role: STUDY_CHAIR
affiliation: Misr University for Science and Technology
name: mostafa mr mohmed, bachaloria
role: PRINCIPAL_INVESTIGATOR
References: