Impact of Somatosensory Intensive Intervention on Motor Performance in Children With Unilateral C… (NCT04235088) | Clinical Trial Compass
CompletedNot Applicable
Impact of Somatosensory Intensive Intervention on Motor Performance in Children With Unilateral Cerebral Palsy
Spain16 participantsStarted 2020-09-05
Plain-language summary
This study aims to investigate the effectiveness of an intensive somatosensory intervention in the upper limb of children with hemiparesis regarding structure, function, activity and participation
Hypothesis:
Intensive somatosensory activity based intervention is effective in upper limb and hand ability in children with hemiparesis, specially regarding activity and participation
Who can participate
Age range
6 Years – 15 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:
* Diagnosis of unilateral cerebral palsy
* Manual Ability Classification System (MACS): levels I, II y III.
* Gender: male and female
* Age: 6 to 15 years old
Exclusion Criteria:
* Existence of a moderate or severe cognitive impairment, which could interfere with the comprehension of the tester cues
* Botulinum toxic infiltration 4 months before the date of the pre-intervention assessment or during intervention or during the 3 months after the final intervention
* To have suffered any injury such as fractures and/or contusions in the upper limb in the last 12 months
* Orthopedic intervention in the 6 months preceding the study or during 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.
What they're measuring
1
Change in Canadian Occupational Performance Measure (COPM).
Timeframe: baseline, immediately after intervention
2
Change in Children´s hand-use Experience Questionnaire (CHEQ).
Timeframe: baseline, immediately after intervention