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Comparative study of the mechanism of action of Dry Needling and Botulinum Toxin type A as a treatment for lower limb post-stroke spasticity: a proof of concept controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510866-18-00
Acronym
49317
Enrollment
60
Registered
2024-07-15
Start date
2025-02-21
Completion date
Unknown
Last updated
2025-02-26

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

Conditions

Spasticity after Stroke

Brief summary

Spasticity: it will be measured with the Tonic Stretch Reflex Threshold and its velocity sensitivity. It will be assessed weekly during 15 weeks (in week 3, two assessments will be conducted- one before the treatment and one after) and on the 19th week

Detailed description

Resistance to passive stretching: measured with the Modified Ashworth Scale (MAS) It will be assessed weekly during 15 weeks and on the 19th week (in week 3, two assessments will be conducted- one before the treatment and one after)., Gait: measured with instrumented gait analysis and the 10 Meter Walk Test (10MWT). It will be assessed on week 1, 2, 9, 15 and 19, Functional mobility: measured with the Time Up and Go (TUG). Assessed on week 1, 2, 9, 15 and 19, Muscle ultrasound (morphometric and densitometric variables): measured with ultrasound imaging. Assessed every week from 1 to 15 and on the 19 week (in week 3, two assessments will be conducted - one before the treatment and one after), Quality of life: measured with the EuroQoL-5D. Assessed on week 1, 15 and 19, Cost-effectiveness: measured with a cost-effectiveness analysis. It will be done after every intervention session (from 3 to 15 week and on 19), sample size, recruitment, and consent rates will be determined, as well as the safety and feasibility of both treatments

Interventions

DRUGBOTOX 50 Allergan Units Powder for solution for injection

Sponsors

University Of Antwerp
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Spasticity: it will be measured with the Tonic Stretch Reflex Threshold and its velocity sensitivity. It will be assessed weekly during 15 weeks (in week 3, two assessments will be conducted- one before the treatment and one after) and on the 19th week

Secondary

MeasureTime frame
Resistance to passive stretching: measured with the Modified Ashworth Scale (MAS) It will be assessed weekly during 15 weeks and on the 19th week (in week 3, two assessments will be conducted- one before the treatment and one after)., Gait: measured with instrumented gait analysis and the 10 Meter Walk Test (10MWT). It will be assessed on week 1, 2, 9, 15 and 19, Functional mobility: measured with the Time Up and Go (TUG). Assessed on week 1, 2, 9, 15 and 19, Muscle ultrasound (morphometric and densitometric variables): measured with ultrasound imaging. Assessed every week from 1 to 15 and on the 19 week (in week 3, two assessments will be conducted - one before the treatment and one after), Quality of life: measured with the EuroQoL-5D. Assessed on week 1, 15 and 19, Cost-effectiveness: measured with a cost-effectiveness analysis. It will be done after every intervention session (from 3 to 15 week and on 19), sample size, recruitment, and consent rates will be determined, as well as t

Countries

Belgium, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026