An interventional study of Prescribed exercise program in Ischemic Stroke and Hemorrhagic Stroke, sponsored by University Rehabilitation Institute, Republic of Slovenia. Recruiting at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by University Rehabilitation Institute, Republic of Slovenia · Not applicable, Interventional, and Supportive care
Patients after stroke with upper limb spasticity treated with botulinum toxin-A (BTX-A) will be included in this two-part study. In the first part, goal attainment scaling and comprehensive assessment of motor functioning will be performed before BTX-A application and after two weeks. In the second part, the patients will be randomised into a test group performing prescribed regular exercise for two weeks and a control group exercising at their own discretion during the same period, whereby the patients' health-related quality of life will be assessed at the beginning and end of the two-week period.
Goal setting will be performed by the patient together with the physician according to the SMART principle (specific, measureable, achievable, realistic, time bound). The goals will be classified according to the International Classification of Functioning, Disability and Health. Goal attainment will be assessed using the Goal Attainment Scale - Light. Comprehensive assessment of motor functioning will address range of motion, spasticity, pain, degree of motor disability and degree of dependence in daily activities. The prescribed exercises for the test group will be passive or active, depending on spasticity of the impaired upper limb. Both groups will keep an Exercise Diary during the second part of the study.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 70 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →University Rehabilitation Institute, Republic of Slovenia is the lead sponsor of 21 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Prescribed exercise program
Behavioral: Prescribed exercise program
Exercising at patient's own discretion
Active or passive exercises for the spastic upper limb, including functional electrical stimulation (FES), performed regularly for two weeks.
GAS-Light
Change in Goal Attainment Scale - Light
Time frame: At baseline, after 2 weeks (i.e., at the end of the 1st part of the study)
SQoL-6D
Change in Spasticity Related Quality of Life Tool score
Time frame: Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)
ROM
Change in Range of motion (degrees)
Time frame: Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)
MAS
Change in Modified Ashworth Scale score
Time frame: Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)
PSFS
Difference in Penn Spasm Frequency Scale
Time frame: Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)
VAS
Change in pain rating on the Visual Analog Scale
Time frame: Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)
BSR
Change in Brunnstrom Stage of Recovery score
Time frame: Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)
MRS
Change in Modified Rankin Scale score
Time frame: Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)
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University Rehabilitation Institute, Republic of Slovenia