Ischemic StrokeGASBTXNCT04975646
Goal Attainment Scaling in Upper Limb Spasticity Treatment
A study testing Prescribed exercise program in people with Ischemic Stroke and Hemorrhagic Stroke, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Hemorrhagic Stroke
- What is being tested?
- Prescribed exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSlovenia
- Study dates
- 3 Jan 2021to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- aphasic patients without caregiver's presence
- other neurological or musculoskeletal diseases that could affect the treatment outcome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
Nataša Bizovičar, MD, PhD, +386 1 4758351, natasa.bizovicar@ir-rs.si
About this study
Official 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
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.
Read the 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
- Being tested
- Prescribed exercise program
- Keywords
- rehabilitation, spasticity, botulinum toxin A, goal setting, spasticity-related quality of life
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescribed exercise programBehavioural
Active or passive exercises for the spastic upper limb, including functional electrical stimulation (FES), performed regularly for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Prescribed exercise program Receives: Behavioral: Prescribed exercise program |
| Control group | No intervention | Exercising at patient's own discretion |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAS-Light
Change in Goal Attainment Scale - Light
Measured: At baseline, after 2 weeks (i.e., at the end of the 1st part of the study)
SQoL-6D
Change in Spasticity Related Quality of Life Tool score
Measured: 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)
Secondary outcomes (6)
ROM
Change in Range of motion (degrees)
Measured: 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)
MAS
Change in Modified Ashworth Scale score
Measured: 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)
PSFS
Difference in Penn Spasm Frequency Scale
Measured: 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)
VAS
Change in pain rating on the Visual Analog Scale
Measured: 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)
BSR
Change in Brunnstrom Stage of Recovery score
Measured: 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)
MRS
Change in Modified Rankin Scale score
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start3 Jan 2021
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- First part: observational study. Second part: parallel groups.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nataša Bizovičar, MD, PhD, Principal investigator, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975646
- Sponsor's protocol ID
- 202102
- Acronym
- GASBTX
- Status last verified
- Jun 2026
- First submitted
- 15 Feb 2021
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04975646
- Acronym / sponsor ID
- GASBTX / 202102
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke
- Keywords
- rehabilitation, spasticity, botulinum toxin A, goal setting, spasticity-related quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- First part: observational study. Second part: parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Behavioral: Prescribed exercise programPrescribed exercise program |
| Control group | No intervention | –Exercising at patient's own discretion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- aphasic patients without caregiver's presence
- other neurological or musculoskeletal diseases that could affect the treatment outcome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prescribed exercise programActive or passive exercises for the spastic upper limb, including functional electrical stimulation (FES), performed regularly for two weeks. | Behavioural | Test group |
Primary outcome
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
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
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nataša Bizovičar, MD, PhD principal investigator
University Rehabilitation Institute, Republic of Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescribed exercise program in people with Ischemic Stroke and Hemorrhagic Stroke, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Metka Moharić, MD, PhD (+386 1 4758441, metka.moharic@ir-rs.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAS-Light (time frame: At baseline, after 2 weeks (i.e., at the end of the 1st part of the study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.