Photo Biostimulation and Spasticity in Cerebral Palsy

NCT ID: NCT05912959

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2024-01-22

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.

Conditions

Cerebral Palsy; Cerebral Palsy, Spastic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

photo biostimulation group

• this group will receive a photo bio stimulation (LASER) session consisting of 3 sessions using the LASER device (VECTRA GENISYS, INTELLECT LEGEND XT, Chattanooga, USA). The following parameters will be used; Power output: 300 mv, Wavelength: 820 nm, Contact area: 0.495; Powr density: 0.606 mW/ cm2, Treatment time per point: 13 seconds, Number of points are three: (GB34, LR3, LIV 3).
• in addition to the LASER, this group will receive a standard physiotherapy program designed by an experienced pediatric physical therapist

Group Type: EXPERIMENTAL

photo biostimulation

Intervention Type: OTHER

the intervention is a type of wavelength around 820 nm. this method of treatment is totally safe. yet, it has many therapeutic effects on the cellular level as well as tissue and organ level. during treatment with laser, the patient does not feel any specific sensation.

standard physiotherapy group

This group will receive a standard physiotherapy program designed by an experienced pediatric physical therapist

Group Type: ACTIVE_COMPARATOR

photo biostimulation

Intervention Type: OTHER

the intervention is a type of wavelength around 820 nm. this method of treatment is totally safe. yet, it has many therapeutic effects on the cellular level as well as tissue and organ level. during treatment with laser, the patient does not feel any specific sensation.

Interventions

photo biostimulation

the intervention is a type of wavelength around 820 nm. this method of treatment is totally safe. yet, it has many therapeutic effects on the cellular level as well as tissue and organ level. during treatment with laser, the patient does not feel any specific sensation.

Intervention Type: OTHER

Other Intervention Names

(Low Level Therapeutic LASER); LASER

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,

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hail

OTHER

Sponsor Role: lead

Responsible Party

Hisham Mohamed Hussein

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Hail

Hail, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

H-2023-313

Identifier Type: -

Identifier Source: org_study_id