NCT04975646

Goal Attainment Scaling in Upper Limb Spasticity Treatment

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University Rehabilitation Institute, Republic of Slovenia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Stroke
• Hemorrhagic Stroke

Interventions

Type	Name	Description
BEHAVIORAL	Prescribed exercise program	Active or passive exercises for the spastic upper limb, including functional electrical stimulation (FES), performed regularly for two weeks.

Timeline

• Start date: 2021-01-03
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2021-07-23
• Last updated: 2024-12-06

Locations

1 site across 1 country: Slovenia