CompletedNot Applicable

Photo Biostimulation and Spasticity in Cerebral Palsy

Saudi Arabia54 participantsStarted 2023-08-15

Plain-language 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

Who can participate

Age range

8 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Modified Ashworth scale for muscle tone assessment

Timeframe: at baseline

Modified Ashworth scale for muscle tone assessment

Timeframe: after the end of the treatment (after 4 weeks)

Modified Ashworth scale for muscle tone assessment

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

plantar surface area

Timeframe: at baseline

plantar surface area

Timeframe: at 4 weeks

plantar surface area

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

Gross Motor Function Measure (GMFM) (88 items)

Timeframe: at baseline

Trial details

NCT IDNCT05912959

SponsorUniversity of Hail

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-01

View on ClinicalTrials.gov More Cerebral Palsy trials

Plain-language summary

Who can participate

Age range

8 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Modified Ashworth scale for muscle tone assessment

Timeframe: at baseline

Modified Ashworth scale for muscle tone assessment

Timeframe: after the end of the treatment (after 4 weeks)

Modified Ashworth scale for muscle tone assessment

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

plantar surface area

Timeframe: at baseline

plantar surface area

Timeframe: at 4 weeks

plantar surface area

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

Gross Motor Function Measure (GMFM) (88 items)

Timeframe: at baseline