Goal Attainment Scaling in Upper Limb Spasticity Treatment

Ischemic Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04975646
• Other study ID #: 202102
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2021
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: University Rehabilitation Institute, Republic of Slovenia
• Contact: Metka Moharic, MD, PhD
• Phone: +386 1 4758441
• Email: metka.moharic[@]ir-rs.si
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Muscle Spasticity
• Stroke

Intervention

Behavioral:
• Prescribed exercise program
Active or passive exercises for the spastic upper limb, including functional electrical stimulation (FES), performed regularly for two weeks.

Locations

Country	Name	City	State
Slovenia	University Rehabilitation Institute, Republic of Slovenia	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Rehabilitation Institute, Republic of Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GAS-Light	Change in Goal Attainment Scale - Light	At baseline, after 2 weeks (i.e., at the end of the 1st part of the study)
Primary	SQoL-6D	Change in Spasticity Related Quality of Life Tool score	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	ROM	Change in Range of motion (degrees)	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	MAS	Change in Modified Ashworth Scale score	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	PSFS	Difference in Penn Spasm Frequency Scale	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	VAS	Change in pain rating on the Visual Analog Scale	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	BSR	Change in Brunnstrom Stage of Recovery score	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	MRS	Change in Modified Rankin Scale score	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)