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NCT Number: NCT04975646

Goal Attainment Scaling in Upper Limb Spasticity Treatment

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhagic Stroke Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location status: Recruiting

Location contact

Nataša Bizovičar, MD, PhD

CONTACT

[email protected]

+386 1 4758351

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prescribed exercise program

Behavioral

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

Primary outcomes

  1. GAS-Light

    Time frame: At baseline, after 2 weeks (i.e., at the end of the 1st part of the study)

    Change in Goal Attainment Scale - Light

  2. SQoL-6D

    Time frame: 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)

    Change in Spasticity Related Quality of Life Tool score

Secondary outcomes

  1. ROM

    Time frame: 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)

    Change in Range of motion (degrees)

  2. MAS

    Time frame: 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)

    Change in Modified Ashworth Scale score

  3. PSFS

    Time frame: 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)

    Difference in Penn Spasm Frequency Scale

  4. VAS

    Time frame: 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)

    Change in pain rating on the Visual Analog Scale

  5. BSR

    Time frame: 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)

    Change in Brunnstrom Stage of Recovery score

  6. MRS

    Time frame: 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)

    Change in Modified Rankin Scale score

Study contacts

Contact information is provided by the study sponsor or research team.

Metka Moharić, MD, PhD

CONTACT

[email protected]

+386 1 4758441

Sponsors and collaborators

Lead sponsor

University Rehabilitation Institute, Republic of Slovenia

Other

Registry information

Official study 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

Acronym: GASBTX

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2021
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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