Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using goal setting to improve treatment for upper limb spasticity after stroke

Official title: Goal Attainment Scaling in Upper Limb Spasticity Treatment With Botulinum Toxin and the Influence of Regular Exercise for Spastic Upper Limb on Quality of Life in Patients After Stroke

Run by University Rehabilitation Institute, Republic of Slovenia · NCT04975646 · Data updated 2026-11-12

This study is testing if setting specific goals and following an exercise program can help people with arm stiffness after a stroke feel better and improve their movement.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment70 (estimated)
SponsorUniversity Rehabilitation Institute, Republic of Slovenia
Academic / other
Locations1 site (Ljubljana)
StatusRecruiting
StartedJanuary 3, 2021
Main results expectedOctober 2026
Study endsOctober 2026
Registry record updatedJune 15, 2026
Trial IDNCT04975646 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals who have suffered an ischemic or hemorrhagic stroke and exhibit significant upper limb muscle spasticity.

Probably not a fit

Patients with other neurological or musculoskeletal diseases that could interfere with treatment outcomes may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on patients who have experienced ischemic or hemorrhagic strokes and are dealing with upper limb spasticity. Participants will undergo a goal attainment scaling process alongside a comprehensive assessment of their motor functioning before and after receiving botulinum toxin-A (BTX-A). Following this, patients will be randomized into two groups: one will follow a prescribed exercise program while the other will exercise at their own discretion, with health-related quality of life being evaluated at the start and end of the two-week period. The study aims to assess the effectiveness of structured goal setting and exercise on recovery outcomes.

Why it matters

Potential benefit: If successful, this approach could enhance rehabilitation outcomes and quality of life for stroke patients with upper limb spasticity.

How similar studies have gone: Previous studies have shown promise in using goal setting and structured rehabilitation approaches for improving outcomes in similar patient populations.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • University Rehabilitation Institute, Republic of Slovenia
    Ljubljana, Slovenia
    Recruiting

Study contacts

  • Principal investigator: Nataša Bizovičar, MD, PhD — University Rehabilitation Institute, Republic of Slovenia
  • Study coordinator: Metka Moharić, MD, PhD
  • Email: metka.moharic@ir-rs.si
  • Phone: +386 1 4758441

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.