search
Back to results

Photo Biostimulation and Spasticity in Cerebral Palsy

Primary Purpose

Calf Muscle Spasticity, Spastic Cerebral Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
photo biostimulation
Sponsored by
University of Hail
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calf Muscle Spasticity

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • University of Hail

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

photo biostimulation group

standard physiotherapy group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
June 11, 2023
Last Updated
June 20, 2023
Sponsor
University of Hail
search

1. Study Identification

Unique Protocol Identification Number
NCT05912959
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 30, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hail

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calf Muscle Spasticity, Spastic Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
photo biostimulation group
Arm Type
Experimental
Arm Description
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
Arm Title
standard physiotherapy group
Arm Type
Active Comparator
Arm Description
This group will receive a standard physiotherapy program designed by an experienced pediatric physical therapist
Intervention Type
Other
Intervention Name(s)
photo biostimulation
Other Intervention Name(s)
(Low Level Therapeutic LASER), LASER
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Ashworth scale for muscle tone assessment
Description
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
Time Frame
at baseline
Title
Modified Ashworth scale for muscle tone assessment
Description
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
Time Frame
after the end of the treatment (after 4 weeks)
Title
Modified Ashworth scale for muscle tone assessment
Description
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
Time Frame
at 4 weeks after the end of the treatment (follow-up)
Title
plantar surface area
Description
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
Time Frame
at baseline
Title
plantar surface area
Description
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
Time Frame
at 4 weeks
Title
plantar surface area
Description
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
Time Frame
at 4 weeks after the end of the treatment (follow-up)
Title
Gross Motor Function Measure (GMFM) (88 items)
Description
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
Time Frame
at baseline
Title
Gross Motor Function Measure (GMFM) (88 items)
Description
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
Time Frame
at 4 weeks
Title
Gross Motor Function Measure (GMFM) (88 items)
Description
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
Time Frame
at 4 weeks after the end of treatment (follow-up)
Title
The pediatric quality of life questionnaire for cerebral palsy
Description
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
Time Frame
at baseline
Title
The pediatric quality of life questionnaire for cerebral palsy
Description
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
Time Frame
at 4 weeks
Title
The pediatric quality of life questionnaire for cerebral palsy
Description
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
Time Frame
at 4 weeks after the end of treatment (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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,
Facility Information:
Facility Name
University of Hail
City
Hail
ZIP/Postal Code
3994
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
this will be discussed with the project funders

Learn more about this trial

Photo Biostimulation and Spasticity in Cerebral Palsy

We'll reach out to this number within 24 hrs