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

• ClinicalTrials.gov Identifier: NCT04789629
• Recruitment Status: Completed
• First Posted: March 9, 2021
• Last Update Posted: March 9, 2021
• Sponsor: National Institute of Laser Enhanced Sciences
• Information provided by (Responsible Party): basma ragab, National Institute of Laser Enhanced Sciences

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	Not Applicable

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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Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomize 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: December 1, 2020
• Actual Primary Completion Date: February 1, 2021
• Actual Study Completion Date: February 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 Name: 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 Name: physiotherapy

Outcome Measures

Primary Outcome Measures :

1. Modified Ashworth scale [ Time Frame: one month of treatment ]
   scale to assets muscle tone
2. Modified Ashworth scale [ Time Frame: 2 months ]
   scale to assets muscle tone
3. rom by Goniometer [ Time Frame: one month of treatment ]
   clinical assessment
4. rom by Goniometer [ Time Frame: 2 months ]
   clinical assessment
5. poplital angle test [ Time Frame: one month of treatment ]
   clinical test
6. poplital angle test [ Time Frame: 2 months ]
   clinical test

Secondary Outcome Measures :

1. gross motor [ Time Frame: one month of treatment ]
   GMFS88
2. gross motor [ Time Frame: 2 months ]
   GMFS88

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Egypt

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

More Information

• Responsible Party: basma ragab, physiotherapist, National Institute of Laser Enhanced Sciences
• ClinicalTrials.gov Identifier: NCT04789629
• Other Study ID Numbers: NILES; our team ( Other Identifier: cairo universtity )
• First Posted: March 9, 2021
• Last Update Posted: March 9, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by basma ragab, National Institute of Laser Enhanced Sciences:

low level laser; spasticity; cerebral palsy

Additional relevant MeSH terms:

Muscle Spasticity; Paralysis; Cerebral Palsy; Neurologic Manifestations; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations