Goal Attainment Scaling in Upper Limb Spasticity Treatment (GASBTX)

University Rehabilitation Institute, Republic of Slovenia

Status: Enrolling

Conditions: Ischemic Stroke; Hemorrhagic Stroke

Treatments: Behavioral: Prescribed exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT04975646

202102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Test group

Experimental group

Description:

Prescribed exercise program

Treatment:

Behavioral: Prescribed exercise program

Control group

No Intervention group

Description:

Exercising at patient's own discretion