Clinical trial NCT04975646: Goal Attainment Scaling in Upper Limb Spasticity Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Hemorrhagic Stroke
Keywords: rehabilitation
spasticity
botulinum toxin A
goal setting
spasticity-related quality of life
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: First part: observational study. Second part: parallel groups.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: GAS-Light
timeFrame: At baseline, after 2 weeks (i.e., at the end of the 1st part of the study)
measure: SQoL-6D
timeFrame: 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 outcomes:
measure: ROM
timeFrame: 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: MAS
timeFrame: 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: PSFS
timeFrame: 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: VAS
timeFrame: 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: BSR
timeFrame: 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: MRS
timeFrame: 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)
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute, Republic of Slovenia
Study officials:
affiliation: University Rehabilitation Institute, Republic of Slovenia
name: Nataša Bizovičar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: