NCT04975646 Goal Attainment Scaling in Upper Limb Spasticity Treatment
| NCT ID | NCT04975646 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Rehabilitation Institute, Republic of Slovenia |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-01-03 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2021-01-03 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients after stroke with upper limb spasticity treated with botulinum toxin-A (BTX-A) will be included in this two-part study. In the first part, goal attainment scaling and comprehensive assessment of motor functioning will be performed before BTX-A application and after two weeks. In the second part, the patients will be randomised into a test group performing prescribed regular exercise for two weeks and a control group exercising at their own discretion during the same period, whereby the patients' health-related quality of life will be assessed at the beginning and end of the two-week period.
Eligibility Criteria
Inclusion Criteria: * patient's or caregiver's approval * ischemic or hemorrhagic stroke diagnosed using head CT/MRI * at least one upper limb muscle spasticity (MAS ≥ 3) * candidate for BTX-A treatment or already given BTX-A in the past * patient's or caregiver's capability for goal attainment protocol cooperation (Mini Mental Examination ≥ 24 points) Exclusion Criteria: * aphasic patients without caregiver's presence * other neurological or musculoskeletal diseases that could affect the treatment outcome
Contact & Investigator
Nataša Bizovičar, MD, PhD
PRINCIPAL INVESTIGATOR
University Rehabilitation Institute, Republic of Slovenia
Frequently Asked Questions
Who can join the NCT04975646 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04975646 currently recruiting?
Yes, NCT04975646 is actively recruiting participants. Contact the research team at metka.moharic@ir-rs.si for enrollment information.
Where is the NCT04975646 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT04975646 clinical trial?
NCT04975646 is sponsored by University Rehabilitation Institute, Republic of Slovenia. The principal investigator is Nataša Bizovičar, MD, PhD at University Rehabilitation Institute, Republic of Slovenia. The trial plans to enroll 70 participants.
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