Photo Biostimulation and Spasticity in Cerebral Palsy

NCT05912959 | Completed

• 1 other identifier: H-2023-313
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebral Palsy; Cerebral Palsy, Spastic

Outcome Measures

Primary Outcomes (12)

• Modified Ashworth scale for muscle tone assessment

  this scale is a simple clinical scale used to assess muscle tone ans spasticity level. it ranges from 1 to 4 where the lowest value indicate normal muscle tone and the largest value indicate high miscle tone

  at baseline

• Modified Ashworth scale for muscle tone assessment

  this scale is a simple clinical scale used to assess muscle tone ans spasticity level. it ranges from 1 to 4 where the lowest value indicate normal muscle tone and the largest value indicate high miscle tone

  after the end of the treatment (after 4 weeks)

• Modified Ashworth scale for muscle tone assessment

  this scale is a simple clinical scale used to assess muscle tone ans spasticity level. it ranges from 1 to 4 where the lowest value indicate normal muscle tone and the largest value indicate high miscle tone

  at 4 weeks after the end of the treatment (follow-up)

• plantar surface area

  A footscan plantar pressure detection system will be used to determine the plantar support area and plantar pressure. This device consists of a force plate (FAS system 1.0 ACP Light, Buratto Advanced Technology, Treviso, Italy), with an active surface (47.5 × 43.0 cm) equipped with 2544 optical sensors distributed along the perimetrical border. it can assess the plantar surface area and the peak pressure in each part of the plantar surface

  at baseline

• plantar surface area

  A footscan plantar pressure detection system will be used to determine the plantar support area and plantar pressure. This device consists of a force plate (FAS system 1.0 ACP Light, Buratto Advanced Technology, Treviso, Italy), with an active surface (47.5 × 43.0 cm) equipped with 2544 optical sensors distributed along the perimetrical border. it can assess the plantar surface area and the peak pressure in each part of the plantar surface

  at 4 weeks

• plantar surface area

  A footscan plantar pressure detection system will be used to determine the plantar support area and plantar pressure. This device consists of a force plate (FAS system 1.0 ACP Light, Buratto Advanced Technology, Treviso, Italy), with an active surface (47.5 × 43.0 cm) equipped with 2544 optical sensors distributed along the perimetrical border. it can assess the plantar surface area and the peak pressure in each part of the plantar surface

  at 4 weeks after the end of the treatment (follow-up)

• Gross Motor Function Measure (GMFM) (88 items)

  Gross Motor Function Measure (GMFM) (88 items) is a tool used to assess changes in gross motor function in cerebral palsy patients. this clinical scale is easy to use and categorize children according to their abilities. where the lower scale mean better gross motor function and higher value means more limitations in gross motor scale

  at baseline

• Gross Motor Function Measure (GMFM) (88 items)

  Gross Motor Function Measure (GMFM) (88 items) is a tool used to assess changes in gross motor function in cerebral palsy patients. this clinical scale is easy to use and categorize children according to their abilities. where the lower scale mean better gross motor function and higher value means more limitations in gross motor scale

  at 4 weeks

• Gross Motor Function Measure (GMFM) (88 items)

  Gross Motor Function Measure (GMFM) (88 items) is a tool used to assess changes in gross motor function in cerebral palsy patients. this clinical scale is easy to use and categorize children according to their abilities. where the lower scale mean better gross motor function and higher value means more limitations in gross motor scale

  at 4 weeks after the end of treatment (follow-up)

• The pediatric quality of life questionnaire for cerebral palsy

  it is a validated tools with strong psychometric properties and clinical utility. The parent proxy's form (parents of children aged 4-12 years) comprises 66 items and the child self-report form (9-12 years) comprises 52 items. Both the child's and the parent proxy's forms have demonstrated good psychometric properties including internal consistency, test-retest reliability, and construct validity. The higher the score, the better the quality of life is represented

  at baseline

• The pediatric quality of life questionnaire for cerebral palsy

  it is a validated tools with strong psychometric properties and clinical utility. The parent proxy's form (parents of children aged 4-12 years) comprises 66 items and the child self-report form (9-12 years) comprises 52 items. Both the child's and the parent proxy's forms have demonstrated good psychometric properties including internal consistency, test-retest reliability, and construct validity. The higher the score, the better the quality of life is represented

  at 4 weeks

• The pediatric quality of life questionnaire for cerebral palsy

  it is a validated tools with strong psychometric properties and clinical utility. The parent proxy's form (parents of children aged 4-12 years) comprises 66 items and the child self-report form (9-12 years) comprises 52 items. Both the child's and the parent proxy's forms have demonstrated good psychometric properties including internal consistency, test-retest reliability, and construct validity. The higher the score, the better the quality of life is represented

  at 4 weeks after the end of treatment (follow-up)

Study Arms (2)

photo biostimulation group

EXPERIMENTAL

* 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

Other: photo biostimulation

standard physiotherapy group

ACTIVE COMPARATOR

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

Other: photo biostimulation

Interventions

photo biostimulation 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.

Also known as: (Low Level Therapeutic LASER), LASER

photo biostimulation group; standard physiotherapy group

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Hail: lead

Study Sites (1)

University of Hail

Hail, 3994, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Lasers

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Concealed allocation will be performed by a researcher who will not be involved in the treatment or assessment. Permuted blocks will be used to assure an equal 1:1 allocation ratio. Due to the nature of the study, the assessor and the patients will be blindfolded (double-blinded). During the first treatment session, the therapist will be allowed to uncover the allocation code to be able to conduct the appropriate treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: June 22, 2023
• Study Start: August 15, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 22, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

SA (1)