Goal Attainment Scaling in Upper Limb Spasticity Treatment

NCT04975646 | Recruiting

• 1 other identifier: 202102
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Hemorrhagic Stroke

Keywords

rehabilitation; spasticity; botulinum toxin A; goal setting; spasticity-related quality of life

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (6)

• ROM

  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

  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

  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

  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

  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)

Study Arms (2)

Test group

EXPERIMENTAL

Prescribed exercise program

Behavioral: Prescribed exercise program

Control group

NO INTERVENTION

Exercising at patient's own discretion

Interventions

Prescribed exercise program BEHAVIORAL

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

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Rehabilitation Institute, Republic of Slovenia: lead

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

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

Study Officials

• Nataša Bizovičar, MD, PhD

  University Rehabilitation Institute, Republic of Slovenia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Metka Moharić, MD, PhD

CONTACT

+386 1 4758441; metka.moharic@ir-rs.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: First part: observational study. Second part: parallel groups.

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: July 23, 2021
• Study Start: January 3, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

SL (1)