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

NCT04789629 | Completed DMC

• 2 other identifiers: NILESour team
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

low level laser; spasticity; cerebral palsy

Outcome Measures

Primary Outcomes (6)

• Modified Ashworth scale

  scale to assets muscle tone

  one month of treatment

• Modified Ashworth scale

  scale to assets muscle tone

  2 months

• rom by Goniometer

  clinical assessment

  one month of treatment

• rom by Goniometer

  clinical assessment

  2 months

• poplital angle test

  clinical test

  one month of treatment

• poplital angle test

  clinical test

  2 months

Secondary Outcomes (2)

• gross motor

  one month of treatment

• gross motor

  2 months

Study Arms (2)

low level laser , physiotherapy

ACTIVE COMPARATOR

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

physiotherapy

ACTIVE COMPARATOR

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

Device: low level laser therapy

Interventions

low level laser therapy DEVICE

3 session per week laser with exercises

Also known as: physiotherapy

low level laser , physiotherapy; physiotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Laser Enhanced Sciences: lead

Study Sites (1)

Out Clinic of Physical Therapy Faculty

Giza, El Dokki, 11432, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Interventions

Low-Level Light Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Rehabilitation

Study Officials

• osama mr fekery, prof

  NILES

  STUDY CHAIR

• asmaa ms osama, assist prof

  physical therapy faculty

  STUDY CHAIR

• mostafa mr mohmed, bachaloria

  Misr University for Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Model Details: randomize clinical trail

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 9, 2021
• Study Start: December 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

EG (1)