Dynamic Orthotic Garment in Diplegic Cerebral Palsy
Saudi Arabia40 participantsStarted 2022-02-17
Plain-language summary
This study aims to evaluate the effectiveness of dynamic orthotic garment (Thera togs) on foot pressure distribution, postural control, functional performance and endurance in children with spastic diplegic cerebral palsy (CP). Methods: forty children with spastic diplegic CP, with ages ranging from 8 to 10 years, will be assigned randomly into two groups. The control group will receive the conventional physical therapy, whereas the study group will receive the same program as the control group in addition to Thera togs. Measurement of foot pressure distribution will be performed using a pressure platform, postural control will be evaluated using the trunk control measurement scale Trunk Position Sense pediatric berg balance scale, endurance will be assessed using six-minute walk test (6MWT)
Who can participate
Age range
8 Years – 10 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:
* children with CP who have toe-in gait and had grade 1+ to 2 degree of spasticity according to the Modified Ashworth Scale (MAS) \[32\]. In addition to score I and II on Gross Motor Function Classification System (GMFCS) scores \[33\]. As well as the child is required to be able to stand and walk independently.
Exclusion Criteria:
* Children who have impaired hearing or vision, previous lower limb surgery or Botulinum injections of the lower limb muscles within the preceding 6 months will be excluded from the study.
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.