Clinical trial NCT05912959: Photo Biostimulation and Spasticity in Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Cerebral Palsy, Spastic
Lead sponsor: University of Hail
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 54
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel model study where 2 groups (experimental and control) will receive specific interventions. then the outcome measures will be assessed at baseline, after treatment (at 4 weeks) then at 3 month follow up
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* age between 8 and 14 years,
* who had a diagnosis of spastic cerebral palsy by a pediatrician, with at least one spastic - muscle in the extremities,
* grades 1 -4 on Gross Motor Function Classification System
* score 1 on the Modified Ashworth Scale (MAS)
* the ability to walk alone or with assistance
* whose parents/guardians sign the informed consent form,
* who were willing to complete the study.

Exclusion Criteria:

* patients with anatomical disorders,
* patients who received a botulinum toxin injection in the calf muscle during the last six months
* surgery in the lower extremity during the previous year
* severe associated neurological diseases such as epilepsy
* poor nutritional status,

Primary outcomes:
measure: Modified Ashworth scale for muscle tone assessment
timeFrame: at baseline
measure: Modified Ashworth scale for muscle tone assessment
timeFrame: after the end of the treatment (after 4 weeks)
measure: Modified Ashworth scale for muscle tone assessment
timeFrame: at 4 weeks after the end of the treatment (follow-up)
measure: plantar surface area
timeFrame: at baseline
measure: plantar surface area
timeFrame: at 4 weeks
measure: plantar surface area
timeFrame: at 4 weeks after the end of the treatment (follow-up)
measure: Gross Motor Function Measure (GMFM) (88 items)
timeFrame: at baseline
measure: Gross Motor Function Measure (GMFM) (88 items)
timeFrame: at 4 weeks
measure: Gross Motor Function Measure (GMFM) (88 items)
timeFrame: at 4 weeks after the end of treatment (follow-up)
measure: The pediatric quality of life questionnaire for cerebral palsy
timeFrame: at baseline
measure: The pediatric quality of life questionnaire for cerebral palsy
timeFrame: at 4 weeks
measure: The pediatric quality of life questionnaire for cerebral palsy
timeFrame: at 4 weeks after the end of treatment (follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Hail
country: Saudi Arabia
facility: University of Hail
Study officials:
References: