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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Prescribed exercise program |
|
| Control group | No Intervention | Exercising at patient's own discretion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prescribed exercise program | Behavioral | Active or passive exercises for the spastic upper limb, including functional electrical stimulation (FES), performed regularly for two weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| GAS-Light | Change in Goal Attainment Scale - Light | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| ROM | Change in Range of motion (degrees) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Metka Moharić, MD, PhD | Contact | +386 1 4758441 | metka.moharic@ir-rs.si |
| Name | Affiliation | Role |
|---|---|---|
| Nataša Bizovičar, MD, PhD | University Rehabilitation Institute, Republic of Slovenia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Rehabilitation Institute, Republic of Slovenia | Recruiting | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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First part: observational study. Second part: parallel groups.
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| 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 | 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 | 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 | 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 | 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) |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |