Goal Attainment Scaling in Upper Limb Spasticity Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Ischemic Stroke, Hemorrhagic Stroke

Intervention / Treatment
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* Behavioral: Prescribed exercise program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: First part: observational study. Second part: parallel groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Prescribed exercise program | Behavioral: Prescribed exercise program<br>* Active or passive exercises for the spastic upper limb, including functional electrical stimulation (FES), performed regularly for two weeks.<br>|
| No Intervention: Control group<br>Exercising at patient's own discretion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, spasticity, botulinum toxin A, goal setting, spasticity-related quality of life