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Leg muscles neuromuscular adaptation of subjects with spasticity before and after Botulinum Toxin Type A application

Leg muscles neuromuscular plasticity of spastic subjects before and after Botulinum Toxin Type A application

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-2scj85
Enrollment
Unknown
Registered
2019-10-15
Start date
2010-01-05
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Stroke, not specified as haemorrhage or infarction

Interventions

Experimental group: 10 post-stroke individuals with plantar flexor muscles spasticity, will be submitted of Botulinum Toxin Type A application on plantar flexor muscles, associated with a physiotherap
H02.010.625

Sponsors

Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Diagnosis of ischemic or hemorrhagic stroke; incident time greater than 12 months; age equal or superior to 20 years; ability to walk with or without crutches; presence of spasticity in the ankle plantiflexor muscles.

Exclusion criteria

Exclusion criteria: Do not use BTX-A for a minimum of 6 months; not be performing physiotherapy; history of surgical procedure or use of orthopedic prosthesis; use of orthoses; cardiovascular and respiratory impairment limiting physical exertion; presence of progressive or insane neurological disease.

Design outcomes

Primary

MeasureTime frame
Muscle strength increased, verified by isokinetic dynamometry, with a variation of at least 5% in pre and post-intervention measurements.;Functional performance improvement, verified by the tests: eight-meter brisk walk, Timed Up and Go and Sit-to-Stand, with a variation of at least 5% in pre and post-intervention measurements.;Muscle architecture improvement, verified by ultrasound, with a variation of at least 5% in pre and post-intervention measurements.

Secondary

MeasureTime frame
Flexibility Increased, verified through goniometry, with a variation of at least 5% in pre and post-intervention measurements.;Spasticity reduction, verified by the Ashworth Modified Scale, with a variation of at least 5% in the pre and post intervention measurements.

Countries

Brazil

Contacts

Public ContactCaroline Dias

Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul

carolpieta@yahoo.com.br+555198448440

Outcome results

None listed

Source: REBEC (via WHO ICTRP)