Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
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