Goal Attainment Scaling in Upper Limb Spasticity Treatment (GASBTX)
Primary Purpose
Ischemic Stroke, Hemorrhagic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Prescribed exercise program
Sponsored by
About this trial
This is an interventional supportive care trial for Ischemic Stroke focused on measuring rehabilitation, spasticity, botulinum toxin A, goal setting, spasticity-related quality of life
Eligibility Criteria
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
Sites / Locations
- University Rehabilitation Institute, Republic of SloveniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Test group
Control group
Arm Description
Prescribed exercise program
Exercising at patient's own discretion
Outcomes
Primary Outcome Measures
GAS-Light
Change in Goal Attainment Scale - Light
SQoL-6D
Change in Spasticity Related Quality of Life Tool score
Secondary Outcome Measures
ROM
Change in Range of motion (degrees)
MAS
Change in Modified Ashworth Scale score
PSFS
Difference in Penn Spasm Frequency Scale
VAS
Change in pain rating on the Visual Analog Scale
BSR
Change in Brunnstrom Stage of Recovery score
MRS
Change in Modified Rankin Scale score
Full Information
NCT ID
NCT04975646
First Posted
February 15, 2021
Last Updated
September 18, 2023
Sponsor
University Rehabilitation Institute, Republic of Slovenia
1. Study Identification
Unique Protocol Identification Number
NCT04975646
Brief Title
Goal Attainment Scaling in Upper Limb Spasticity Treatment
Acronym
GASBTX
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Rehabilitation Institute, Republic of Slovenia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Hemorrhagic Stroke
Keywords
rehabilitation, spasticity, botulinum toxin A, goal setting, spasticity-related quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
First part: observational study. Second part: parallel groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Arm Description
Prescribed exercise program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Exercising at patient's own discretion
Intervention Type
Behavioral
Intervention Name(s)
Prescribed exercise program
Intervention Description
Active or passive exercises for the spastic upper limb, including functional electrical stimulation (FES), performed regularly for two weeks.
Primary Outcome Measure Information:
Title
GAS-Light
Description
Change in Goal Attainment Scale - Light
Time Frame
At baseline, after 2 weeks (i.e., at the end of the 1st part of the study)
Title
SQoL-6D
Description
Change in Spasticity Related Quality of Life Tool score
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)
Secondary Outcome Measure Information:
Title
ROM
Description
Change in Range of motion (degrees)
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)
Title
MAS
Description
Change in Modified Ashworth Scale score
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)
Title
PSFS
Description
Difference in Penn Spasm Frequency Scale
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)
Title
VAS
Description
Change in pain rating on the Visual Analog Scale
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)
Title
BSR
Description
Change in Brunnstrom Stage of Recovery score
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)
Title
MRS
Description
Change in Modified Rankin Scale score
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Metka Moharić, MD, PhD
Phone
+386 1 4758441
Email
metka.moharic@ir-rs.si
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nataša Bizovičar, MD, PhD
Organizational Affiliation
University Rehabilitation Institute, Republic of Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Rehabilitation Institute, Republic of Slovenia
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nataša Bizovičar, MD, PhD
Phone
+386 1 4758351
Email
natasa.bizovicar@ir-rs.si
12. IPD Sharing Statement
Learn more about this trial
Goal Attainment Scaling in Upper Limb Spasticity Treatment
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