cp: Effect of Low Level Laser Therapy on Hamstring Muscle Tightness and Calf Muscle Spasticity in Cerebral Palsy Children.

Sponsor

National Institute of Laser Enhanced Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT04789629

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

14.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Device: low level laser therapy	N/A

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 .

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomize clinical trailrandomize clinical trail

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Low Level Laser Therapy on Hamstring Muscle Tightness and Calf Muscle Spasticity in Cerebral Palsy Children.

Actual Study Start Date :

Dec 1, 2020

Actual Primary Completion Date :

Feb 1, 2021

Actual Study Completion Date :

Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: low level laser , physiotherapy Instrumentation Diode laser device will use for biostimulation of the muscle fiber . The device has a wavelength of 808 nm and a power output 0-250 mW. parameters of laser : Wavelength 808 nm Power output 100 mW Spot size 0.0314 cm2 Power density 3,18 W/cm2 Treatment time per point 40 s Energy density per point 4,77 J/cm2 Energy per point 4 J 12 sessions for one month with traditional physiotherapy ( stretching , strenghthing exercises , trunk control , balance training , standing exercises , gait training .)	Device: low level laser therapy 3 session per week laser with exercises Other Names: physiotherapy
Active Comparator: physiotherapy traditional physiotherapy ( stretching , strenghthing exercises , trunk control , balance training , standing exercises , gait training ) for one hour	Device: low level laser therapy 3 session per week laser with exercises Other Names: physiotherapy

Arm

Intervention/Treatment

Active Comparator: low level laser , physiotherapy

Instrumentation Diode laser device will use for biostimulation of the muscle fiber . The device has a wavelength of 808 nm and a power output 0-250 mW. parameters of laser : Wavelength 808 nm Power output 100 mW Spot size 0.0314 cm2 Power density 3,18 W/cm2 Treatment time per point 40 s Energy density per point 4,77 J/cm2 Energy per point 4 J 12 sessions for one month with traditional physiotherapy ( stretching , strenghthing exercises , trunk control , balance training , standing exercises , gait training .)

Device: low level laser therapy

3 session per week laser with exercises

Other Names:

physiotherapy

Active Comparator: physiotherapy

traditional physiotherapy ( stretching , strenghthing exercises , trunk control , balance training , standing exercises , gait training ) for one hour

Device: low level laser therapy

3 session per week laser with exercises

Other Names:

physiotherapy

Outcome Measures

Primary Outcome Measures

Modified Ashworth scale [one month of treatment]
scale to assets muscle tone
Modified Ashworth scale [2 months]
scale to assets muscle tone
rom by Goniometer [one month of treatment]
clinical assessment
rom by Goniometer [2 months]
clinical assessment
poplital angle test [one month of treatment]
clinical test
poplital angle test [2 months]
clinical test

Secondary Outcome Measures

gross motor [one month of treatment]
GMFS88
gross motor [2 months]
GMFS88

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Out Clinic of Physical Therapy Faculty	Giza	El Dokki	Egypt	11432

Sponsors and Collaborators

National Institute of Laser Enhanced Sciences

Investigators

Study Chair: osama mr fekery, prof, NILES
Study Chair: asmaa ms osama, assist prof, physical therapy faculty
Principal Investigator: mostafa mr mohmed, bachaloria, Misr University for Science and Technology