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

NCT ID: NCT04789629

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-02-01

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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Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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 .)

Group Type: ACTIVE_COMPARATOR

low level laser therapy

Intervention Type: DEVICE

3 session per week laser with exercises

physiotherapy

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

Group Type: ACTIVE_COMPARATOR

low level laser therapy

Intervention Type: DEVICE

3 session per week laser with exercises

Interventions

low level laser therapy

3 session per week laser with exercises

Intervention Type: DEVICE

Other Intervention Names

physiotherapy

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Laser Enhanced Sciences

OTHER

Sponsor Role: lead

Responsible Party

basma ragab

physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

osama mr fekery, prof

Role: STUDY_CHAIR

NILES

asmaa ms osama, assist prof

Role: STUDY_CHAIR

physical therapy faculty

mostafa mr mohmed, bachaloria

Role: PRINCIPAL_INVESTIGATOR

Misr University for Science and Technology

Locations

Out Clinic of Physical Therapy Faculty

Giza, El Dokki, Egypt

Countries

Egypt

Other Identifiers

our team

Identifier Type: OTHER

Identifier Source: secondary_id

NILES

Identifier Type: -

Identifier Source: org_study_id