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Early Injection of Botulinum Toxin on Motor Function and Gait Pattern in Stroke Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01817816
Enrollment
80
Registered
2013-03-25
Start date
2009-01-31
Completion date
2015-06-30
Last updated
2015-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spasticity, Stroke

Brief summary

Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke patients. They cause disabled condition of patients in activities of daily life and functional performance, and also accidental falls and subsequent fractures. This study is to evaluate and compare the effects of different phase injection of Botulinum Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone, functional performance, gait pattern and energy consumption in stroke patients.

Interventions

PROCEDUREBotox_A
PROCEDUREBotox_B

Sponsors

Changhua Christian Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* first-ever stroke, with spasticity within 3-months (MAS=2\ 3) * independent walking 10 meters (with assistive devices)

Exclusion criteria

* recurrent stroke, cognition impaired * lower limb fracture * received anti-spasticity injection in the past

Design outcomes

Primary

MeasureTime frameDescription
Change in the muscle tone in upper and lower extremity4 weeks after injectionuse modified Ashworth Scale to access elbow, wrist, ankle joint muscle tone 0: normal 1. slight hypertonus, at the end-range 1+: mild hypertonus, catch when limb is moved (\<1/2) 2. moderate hypertonus,, limbs moves easily (\>1/2) 3. passive movement difficult 4. rigid

Secondary

MeasureTime frame
Change in the gait pattern as walking4 weeks after intervention

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026