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Completed

NCT Number: NCT05912959

Photo Biostimulation and Spasticity in Cerebral Palsy

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy, Spastic Nervous System Diseases

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hail

Ha'il, 3994, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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.

Other names: (Low Level Therapeutic LASER), LASER

Primary outcomes

  1. Modified Ashworth scale for muscle tone assessment

    Time frame: at baseline

    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

  2. Modified Ashworth scale for muscle tone assessment

    Time frame: after the end of the treatment (after 4 weeks)

    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

  3. Modified Ashworth scale for muscle tone assessment

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

    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

  4. plantar surface area

    Time frame: at baseline

    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

  5. plantar surface area

    Time frame: at 4 weeks

    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

  6. plantar surface area

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

    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

  7. Gross Motor Function Measure (GMFM) (88 items)

    Time frame: at baseline

    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

  8. Gross Motor Function Measure (GMFM) (88 items)

    Time frame: at 4 weeks

    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

  9. Gross Motor Function Measure (GMFM) (88 items)

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

    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

  10. The pediatric quality of life questionnaire for cerebral palsy

    Time frame: at baseline

    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

  11. The pediatric quality of life questionnaire for cerebral palsy

    Time frame: at 4 weeks

    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

  12. The pediatric quality of life questionnaire for cerebral palsy

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

    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

Sponsors and collaborators

Lead sponsor

University of Hail

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2023
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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