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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623001135606
Enrollment
55
Registered
2023-11-03
Start date
2024-04-24
Completion date
2027-04-30
Last updated
2026-08-24

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

Conditions

None listed

Brief 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.

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 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

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.

Sponsors

A/Prof Ian Baguley
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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 criteria

• 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

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 31, 2026