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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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Slovenia
University Rehabilitation Institute, Republic of Slovenia
RECRUITING
Ljubljana
Contact Information
Primary
Metka Moharić, MD, PhD
metka.moharic@ir-rs.si
+386 1 4758441
Time Frame
Start Date: 2021-01-03
Estimated Completion Date: 2026-10
Participants
Target number of participants: 70
Treatments
Experimental: Test group
Prescribed exercise program
No_intervention: Control group
Exercising at patient's own discretion
Related Therapeutic Areas
Sponsors
Leads: University Rehabilitation Institute, Republic of Slovenia

This content was sourced from clinicaltrials.gov