Viewing Study NCT05912959


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Ignite Modification Date: 2025-12-27 @ 9:35 AM
Study NCT ID: NCT05912959
Status: COMPLETED
Last Update Posted: 2024-05-10
First Post: 2023-06-11
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Photo Biostimulation and Spasticity in Cerebral Palsy
Sponsor: University of Hail
Organization:

Study Overview

Official Title: Efficacy of Adding Photo Biostimulation to Standard Physical Therapy Treatment for Spastic Calf Muscle on Tone, Gross Motor Function, Planter Surface Area, and Quality of Life
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: the current study will address the spasticity in calf muscle secondary to cerebral palsy in children. As the spasticity can inversely affect muscle contraction, joint function, and consequently the function and quality of life, the current study will investigate the effect of adding photobiostimulation therapy to standard physiotherapy on muscle tone, ankle range of motion, gross motor function, plantar surface of the affected foot, and quality of life in patients with spastic cerebral palsy
Detailed Description: spasticity is one of the common complications associated with upper motor neuron injuries such as cerebral palsy. it can affect the normal developmental process of the child as it restricts muscle performance, limit range of motion, decrease function, and affect the ability to engage in daily activities.

the current study will include 2 groups of children having spastic cerebral palsy. these groups will be randomly distributed to the experimental group (receive standard physiotherapy treatment plus photo biostimulation therapy on related acupuncture points) and the control group will receive a standard physiotherapy program.

the duration of the intervention will be 1 month, 3 sessions per week. the outcome measures will be assessed at baseline, at the end of the intervention ( after 4 weeks of treatment), and at 3 months follow-up.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: