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Effect of Botulinum Toxin Type A on neuromuscular adaptations in individuals with muscle stiffness after Stroke

Effect of Botulinum Toxin Type A on neuromuscular plasticity in individuals with spasticity post-Stroke

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-7s8qnjj
Enrollment
Unknown
Registered
2022-04-27
Start date
2022-05-09
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

Muscle strength

Interventions

Experimental group (n=10): physiotherapy associated with the application of botulinum toxin type A. Participants will undergo physiotherapy treatment for a period of 12 weeks with two weekly sessions

Sponsors

Universidade Federal do Rio Grande do Sul -UFRGS
Lead Sponsor
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul- PUCRS
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: individuals over 18 years of age; of both sexes; who have suffered a stroke; incident time greater than 12 months; ability to walk with or without crutches/canes; presence of spasticity in the ankle plantarflexor muscles

Exclusion criteria

Exclusion criteria: Individuals in rehabilitation or any treatment of a kinetic-functional nature; individuals who have already applied botulinum toxin for less than six months; history of surgical procedure or use of orthopedic prosthesis; presence of neurological disease or dementia; cognitive alteration that prevents understanding of the research; presence of joint or musculoskeletal injury of an inflammatory nature

Design outcomes

Primary

MeasureTime frame
Evaluate the muscle architecture through means of ultrasound, noting a variation of at least 5% in pre and post-intervention intra and inter-group measurements, expecting to find greater muscle fiber length and less muscle cross-sectional area in the experimental group compared to placebo

Secondary

MeasureTime frame
Evaluate the torque production capacity through isokinetic dynamometry, noting a variation of at least 5% in pre and post-intervention intra and inter-group measurements, expecting to find less force production in the experimental group compared to the placebo;Evaluate functional performance through the eight-meter walk, Timed Up and Go and Sit and Stand tests, noting a variation of at least 5% in pre and post-intervention intra and inter-group measurements, expecting to find better functional performance in the experimental group compared to placebo;Evaluate the myoelectric properties through electromyography of the medial gastrocnemius, soleus and tibialis anterior muscles, noting a variation of at least 5% in pre and post-intervention intra and inter-group measurements, expecting to find less muscle electrical activity in the experimental group compared to the placebo;Evaluate the spasticity level using the Modified Ashworth Scale, noting a variation of at least 5% in pre and post-intervention intra and inter-group measurements, expecting to find lower spasticity level in the experimental group compared to placebo

Countries

Brazil

Contacts

Public ContactBruno Freire

Centro de Ciências da Saúde e do Esporte,Universidade do Estado de Santa Catarina

freire.brunobolla@hotmail.com+554836368600

Outcome results

None listed

Source: REBEC (via WHO ICTRP)