RecruitingACTRN12623001135606

Measurement of involuntary muscle contraction in adults with spasticity

Objective measurement of muscle co-contraction pre-and post-Botulinum Toxin-A injection in adults with focal spasticity


Sponsor

A/Prof Ian Baguley

Enrollment

90 participants

Start Date

Apr 24, 2024

Study Type

Observational

Conditions

Summary

This study aims first, to objectively measure co-contraction phenomena during a functionally based repeated grasp and release task in adults with UMN syndrome resulting from a neurological diagnosis. Second, to demonstrate the relationship/impact of abnormal muscle co-contraction on everyday function. Finally, this study aims to objectively measure change in maladaptive co-contraction following OnabotulinumtoxinA injection. This study will contribute to the body of knowledge regarding the pathophysiology of maladaptive muscle co-contraction and explore the impact of co-contraction on everyday function.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria10

  • Clinical Group:
  • Ability to understand verbal instructions in English
  • Motor overactivity resulting from an UMN syndrome of greater than 3 months duration
  • Predominately unilateral disability.
  • Presence of active grip strength in the most affected upper limb (a minimum of 0.75kg of force)
  • People who are receiving Botulinum Toxin-A injections as part of their spasticity management.
  • Control group
  • Age 18+ years
  • Ability to understand verbal instructions in English
  • Available for two assessments

Exclusion Criteria7

  • Other causes of upper limb weakness including non-neurological pain, rheumatological conditions, lower motor neuron lesions, etc.
  • Inadequate ability to understand and follow instructions, such as language barriers or inadequate voluntary motor control.
  • People with spasticity who are not being offered OnabotulinumtoxinA injections as a clinical treatment.
  • People with a known contraindication to OnabotulinumtoxinA e.g., Eaton-Lambert syndrome, pregnancy, hypersensitivity etc.
  • Control group
  • Self-reported neurological impairment
  • Self-reported acute or chronic arm injury or impairment

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Interventions

This study will observe upper limb outcomes pre/post Botulinum Toxin-A injection as a part of routine clinical spasticity management for adults with focal spasticity. The gold standard for Botulinum T

This study will observe upper limb outcomes pre/post Botulinum Toxin-A injection as a part of routine clinical spasticity management for adults with focal spasticity. The gold standard for Botulinum Toxin-A injections has moved to individualised injection protocols based on self-selected goals, this means that the pattern of muscles injected, The dose injected into those muscles and the frequency of re-injection is determined an individual basis, The number of injection sites per muscle will be left to the discretion of the injecting physician, with a note made in the record as to what was done. In most situations maximum overall dose will be 400 BOTOX units, however, there will be some people that have in excess of this based on past clinical experience. Observations will focus on change in functional upper limb use, immediately prior to (<=1 week) and 4-6 weeks after injection for one or 2 treatment cycles. Patients will be injected with BOTOX based on clinical need and irrespective of their willingness to be enrolled as a participant in the study.


Locations(1)

NSW, Australia

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