Hemorrhagic Stroke, Ischemic Stroke
Conditions
Keywords
rehabilitation, spasticity, botulinum toxin A, goal setting, spasticity-related quality of life
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPrescribed exercise program
Active or passive exercises for the spastic upper limb, including functional electrical stimulation (FES), performed regularly for two weeks.
Sponsors
University Rehabilitation Institute, Republic of Slovenia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
First part: observational study. Second part: parallel groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GAS-Light | At baseline, after 2 weeks (i.e., at the end of the 1st part of the study) | Change in Goal Attainment Scale - Light |
| SQoL-6D | 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) | Change in Spasticity Related Quality of Life Tool score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ROM | 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) | Change in Range of motion (degrees) |
| MAS | 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) | Change in Modified Ashworth Scale score |
| PSFS | 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) | Difference in Penn Spasm Frequency Scale |
| VAS | 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) | Change in pain rating on the Visual Analog Scale |
| BSR | 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) | Change in Brunnstrom Stage of Recovery score |
| MRS | 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) | Change in Modified Rankin Scale score |
Countries
Slovenia
Contacts
CONTACTMetka Moharić, MD, PhD
PRINCIPAL_INVESTIGATORNataša Bizovičar, MD, PhD
University Rehabilitation Institute, Republic of Slovenia
Outcome results
None listed