Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT01189058
Eligibility Criteria:
Inclusion criteria:
1. Symptomatic hemiplegic CP with impairment(s) of the upper extremity including the hand (Pediatric Stroke Outcome Measure motor \>0.5; AND Manual Ability Classification System I, II,III, or IV; AND both child and parent perceive functional limitations (able to identify personally meaningful deficits in function).
2. MRI confirmed AIS-MCA or PVI (neuroradiological syndrome classified by two blinded, experienced investigators according to previously validated methods)
3. Age at enrollment: 6-18 years
4. Resident in province of Alberta for period of study
5. Informed consent/assent
Exclusion criteria:
1. Multifocal perinatal stroke or other brain injury/abnormality
2. Severe hemiparesis (no voluntary contraction in paretic hand, MACS level V)
3. Intellectual disability causing an inability to comply with study protocol
4. Unstable epilepsy (\>1 seizure/month or \>2 medication changes (dose or agent) in the last 6 months or history of recurrent status epilepticus)
5. Any TMS contraindication including implanted electronic devices
6. Botulinum toxin A injection in the affected upper extremity within the preceding 6 months
7. Orthopedic surgery in the affected upper extremity in the previous 12 months
8. Unwilling to delay any new therapeutic rehabilitational intervention directed towards upper limb function (aside from study home program) for the 6 month duration of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT01189058
Study Brief:
Protocol Section:
NCT01189058