RecruitingNot ApplicableNCT04975646

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


Sponsor

University Rehabilitation Institute, Republic of Slovenia

Enrollment

70 participants

Start Date

Jan 3, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria2

  • aphasic patients without caregiver's presence
  • other neurological or musculoskeletal diseases that could affect the treatment outcome

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Interventions

BEHAVIORALPrescribed exercise program

Active or passive exercises for the spastic upper limb, including functional electrical stimulation (FES), performed regularly for two weeks.


Locations(1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, Slovenia

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NCT04975646


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