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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
low level laser therapy
Sponsored by
National Institute of Laser Enhanced Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring low level laser, spasticity, cerebral palsy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Out Clinic of Physical Therapy Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

low level laser , physiotherapy

physiotherapy

Arm Description

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 .)

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

Outcomes

Primary Outcome Measures

Modified Ashworth scale
scale to assets muscle tone
Modified Ashworth scale
scale to assets muscle tone
rom by Goniometer
clinical assessment
rom by Goniometer
clinical assessment
poplital angle test
clinical test
poplital angle test
clinical test

Secondary Outcome Measures

gross motor
GMFS88
gross motor
GMFS88

Full Information

First Posted
March 3, 2021
Last Updated
March 5, 2021
Sponsor
National Institute of Laser Enhanced Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04789629
Brief Title
Effect of Low Level Laser Therapy on Hamstring Muscle Tightness and Calf Muscle Spasticity in Cerebral Palsy Children.
Acronym
cp
Official Title
Effect of Low Level Laser Therapy on Hamstring Muscle Tightness and Calf Muscle Spasticity in Cerebral Palsy Children.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Laser Enhanced Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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 . .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
low level laser, spasticity, cerebral palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomize clinical trail
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low level laser , physiotherapy
Arm Type
Active Comparator
Arm Description
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 .)
Arm Title
physiotherapy
Arm Type
Active Comparator
Arm Description
traditional physiotherapy ( stretching , strenghthing exercises , trunk control , balance training , standing exercises , gait training ) for one hour
Intervention Type
Device
Intervention Name(s)
low level laser therapy
Other Intervention Name(s)
physiotherapy
Intervention Description
3 session per week laser with exercises
Primary Outcome Measure Information:
Title
Modified Ashworth scale
Description
scale to assets muscle tone
Time Frame
one month of treatment
Title
Modified Ashworth scale
Description
scale to assets muscle tone
Time Frame
2 months
Title
rom by Goniometer
Description
clinical assessment
Time Frame
one month of treatment
Title
rom by Goniometer
Description
clinical assessment
Time Frame
2 months
Title
poplital angle test
Description
clinical test
Time Frame
one month of treatment
Title
poplital angle test
Description
clinical test
Time Frame
2 months
Secondary Outcome Measure Information:
Title
gross motor
Description
GMFS88
Time Frame
one month of treatment
Title
gross motor
Description
GMFS88
Time Frame
2 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
osama mr fekery, prof
Organizational Affiliation
NILES
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
asmaa ms osama, assist prof
Organizational Affiliation
physical therapy faculty
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
mostafa mr mohmed, bachaloria
Organizational Affiliation
Misr University for Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Out Clinic of Physical Therapy Faculty
City
Giza
State/Province
El Dokki
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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