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Goal Attainment Scaling in Upper Limb Spasticity Treatment

NCT ID: NCT04975646

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-03

Study Completion Date

2026-10-31

Brief Summary

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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

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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

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Ischemic Stroke Hemorrhagic Stroke

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

First part: observational study. Second part: parallel groups.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Test group

Prescribed exercise program

Group Type EXPERIMENTAL

Prescribed exercise program

Intervention Type BEHAVIORAL

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

Control group

Exercising at patient's own discretion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prescribed exercise program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Rehabilitation Institute, Republic of Slovenia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nataša Bizovičar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Rehabilitation Institute, Republic of Slovenia

Locations

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University Rehabilitation Institute, Republic of Slovenia

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Metka Moharić, MD, PhD

Role: CONTACT

Phone: +386 1 4758441

Email: [email protected]

Facility Contacts

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Nataša Bizovičar, MD, PhD

Role: primary

Other Identifiers

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202102

Identifier Type: -

Identifier Source: org_study_id