Using goal setting to improve treatment for upper limb spasticity after stroke
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
NA · University Rehabilitation Institute, Republic of Slovenia · NCT04975646
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Rehabilitation Institute, Republic of Slovenia (other) |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT04975646 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals who have suffered an ischemic or hemorrhagic stroke and exhibit significant upper limb muscle spasticity.
Not a fit: Patients with other neurological or musculoskeletal diseases that could interfere with treatment outcomes may not benefit from this study.
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 performed: Previous studies have shown promise in using goal setting and structured rehabilitation approaches for improving outcomes in similar patient populations.
Eligibility criteria
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 this trial is running
Ljubljana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemic Stroke, Hemorrhagic Stroke, rehabilitation, spasticity, botulinum toxin A, goal setting, spasticity-related quality of life