Goal Attainment Scaling in Upper Limb Spasticity Treatment
- Conditions
- Hemorrhagic StrokeIschemic Stroke
- Interventions
- Behavioral: Prescribed exercise program
- Registration Number
- NCT04975646
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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)
- aphasic patients without caregiver's presence
- other neurological or musculoskeletal diseases that could affect the treatment outcome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test group Prescribed exercise program Prescribed exercise program
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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
Trial Locations
- Locations (1)
University Rehabilitation Institute, Republic of Slovenia
🇸🇮Ljubljana, Slovenia