Goal Attainment Scaling in Upper Limb Spasticity Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Rehabilitation Institute, Republic of Slovenia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
aphasic patients without caregiver's presence
other neurological or musculoskeletal diseases that could affect the treatment outcome
Trial design
Design model
Parallel
Treatments tested in this trial
Prescribed exercise program
BehavioralActive or passive exercises for the spastic upper limb, including functional electrical stimulation (FES), performed regularly for two weeks.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Test groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
GAS-Light
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)2
SQoL-6D
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 outcomes
1
ROM
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)2
MAS
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)3
PSFS
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)4
VAS
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)Sponsors and contacts
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Source ClinicalTrials.gov