Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04789629
Other study ID # NILES
Secondary ID our team
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date February 1, 2021

Study information

Verified date March 2021
Source national institute of laser enhanced sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 . .


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
low level laser therapy
3 session per week laser with exercises

Locations

Country Name City State
Egypt Out Clinic of Physical Therapy Faculty Giza El Dokki

Sponsors (1)

Lead Sponsor Collaborator
national institute of laser enhanced sciences

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Ashworth scale scale to assets muscle tone one month of treatment
Primary Modified Ashworth scale scale to assets muscle tone 2 months
Primary rom by Goniometer clinical assessment one month of treatment
Primary rom by Goniometer clinical assessment 2 months
Primary poplital angle test clinical test one month of treatment
Primary poplital angle test clinical test 2 months
Secondary gross motor GMFS88 one month of treatment
Secondary gross motor GMFS88 2 months
See also
  Status Clinical Trial Phase
Recruiting NCT05317234 - Genetic Predisposition in Cerebral Palsy N/A
Recruiting NCT05576948 - Natural History of Cerebral Palsy Prospective Study
Completed NCT04119063 - Evaluating Wearable Robotic Assistance on Gait Early Phase 1
Completed NCT03264339 - The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy N/A
Completed NCT05551364 - Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy N/A
Completed NCT03902886 - Independent Walking Onset of Children With Cerebral Palsy
Recruiting NCT05571033 - Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy N/A
Not yet recruiting NCT04081675 - Compliance in Children With Cerebral Palsy Supplied With AFOs
Completed NCT02167022 - Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy N/A
Completed NCT04012125 - The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy N/A
Enrolling by invitation NCT05619211 - Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities Phase 1
Completed NCT04489498 - Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Completed NCT03677193 - Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy N/A
Recruiting NCT06450158 - Robot-assisted Training in Children With CP N/A
Completed NCT04093180 - Intensive Neurorehabilitation for Cerebral Palsy N/A
Completed NCT02909127 - The Pediatric Eating Assessment Tool
Not yet recruiting NCT06377982 - Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy Phase 1
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT03183427 - Corpus Callosum Size in Patients With Pineal Cyst N/A
Active, not recruiting NCT03078621 - Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy Phase 1/Phase 2