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Search / Trial NCT04975646

Goal Attainment Scaling in Upper Limb Spasticity Treatment

Launched by UNIVERSITY REHABILITATION INSTITUTE, REPUBLIC OF SLOVENIA · Jul 14, 2021

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Rehabilitation Spasticity Botulinum Toxin A Goal Setting Spasticity Related Quality Of Life

ClinConnect Summary

This clinical trial is studying how well a treatment called botulinum toxin-A (BTX-A) can help patients who have had a stroke and experience tightness or stiffness in their arm muscles, known as upper limb spasticity. The trial has two parts: first, researchers will assess each patient's motor skills and set specific goals for improvement before and two weeks after receiving the BTX-A treatment. In the second part, patients will be divided into two groups. One group will follow a structured exercise program, while the other group will exercise as they prefer. The goal is to see how these different approaches to exercise affect the patients' quality of life.

To be eligible for this trial, participants must be aged 65 to 74, have had either an ischemic (blockage in blood flow) or hemorrhagic (bleeding in the brain) stroke, and have at least some muscle stiffness in their arms. They also need to be able to understand and cooperate with the study's goals. Patients who have severe speech difficulties or other serious health issues that might interfere with the results will not be included. Those who join the study can expect to receive support and guidance throughout the process as they work towards improving their arm function and overall well-being.

Gender

ALL

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

About University Rehabilitation Institute, Republic Of Slovenia

The University Rehabilitation Institute in the Republic of Slovenia is a leading clinical research organization dedicated to advancing rehabilitation science and practice. Affiliated with the University of Ljubljana, the institute focuses on innovative rehabilitation methodologies and evidence-based practices to enhance patient outcomes. With a multidisciplinary team of experts, the institute conducts rigorous clinical trials aimed at improving the quality of life for individuals with various disabilities and health conditions. Its commitment to research excellence and collaboration fosters the development of novel therapeutic interventions and contributes to the global knowledge base in rehabilitation medicine.

Locations

Ljubljana, , Slovenia

Patients applied

0 patients applied

Trial Officials

Nataša Bizovičar, MD, PhD

Principal Investigator

University Rehabilitation Institute, Republic of Slovenia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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