Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04975646

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

Led by University Rehabilitation Institute, Republic of Slovenia · Updated on 2024-12-06

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate goal attainment and the effects of regular exercise on health-related quality of life in patients after stroke who have upper limb spasticity treated with botulinum toxin-A (BTX-A). The study involves patients diagnosed with ischemic or hemorrhagic stroke and focuses on assessing motor function and goal achievement following BTX-A treatment. It is conducted in two parts to better understand how exercise impacts recovery and quality of life in this population. In the first part of the study, patients set specific, measurable, achievable, realistic, and time-bound (SMART) goals together with their physician, which are then assessed using the Goal Attainment Scale - Light before and two weeks after BTX-A application. After this, patients are randomized into two groups: one follows a prescribed exercise program consisting of active or passive exercises, including functional electrical stimulation, for two weeks; the other group exercises at their own discretion during the same period. Both groups keep an exercise diary during the second part. Participants will undergo comprehensive assessments of motor functioning including range of motion, spasticity, pain, motor disability, and daily activity dependence at baseline, after two weeks, and at the end of the four-week study. Health-related quality of life is measured at the start and end of the exercise period. Researchers will evaluate goal attainment and quality of life changes, with ongoing monitoring during the study. Total participation includes initial assessment, two-week BTX-A follow-up, and a further two-week exercise intervention phase.

CONDITIONS

Brief Title

Goal Attainment Scaling in Upper Limb Spasticity Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient's or caregiver's approval
  • Diagnosis of ischemic or hemorrhagic stroke confirmed by head CT or MRI
  • Presence of upper limb muscle spasticity with Modified Ashworth Scale of 3 or higher
  • Candidate for botulinum toxin-A treatment or previously treated with botulinum toxin-A
  • Capability for goal attainment protocol cooperation with Mini Mental Examination score of 24 points or higher
Not Eligible

You will not qualify if you...

  • Aphasic patients without caregiver presence
  • Other neurological or musculoskeletal diseases that could affect treatment outcomes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Prescribed Exercise Program

Duration - 2 weeks

Participants in the test group perform prescribed active or passive exercises for the spastic upper limb, including functional electrical stimulation, regularly for two weeks. Control group participants exercise at their own discretion.

Baseline visit and 1 follow-up visit at 2 weeks

Follow-up Assessment

Duration - 2 weeks

Participants complete assessments of motor functioning, quality of life, and goal attainment.

Visits at the start and end of this 2-week period (weeks 2 and 4)

Trial Site Locations

Total: 1 location

1

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, Slovenia, 1000

Actively Recruiting

Loading map...

Research Team

M

Metka Moharić, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Similar Trials

18F FDG and 68Ga FAPI PET/MR Imaging of Carotid Artery Plaqu...

Carotid Artery Plaque

Actively Recruiting

1 location

Efficacy and Safety of Bevifibatide Citrate Injection in Pat...

Ischemic Stroke, Acute

Actively Recruiting

1 location

A Prospective, First in Human Pivotal Study to Evaluate the ...

Ischemic Stroke

Actively Recruiting

15 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here