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Electromyography to assess the change in muscle activity as a result of intrathecal baclofen treatment

Conditions
spasticity
10029317
Registration Number
NL-OMON53254
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
32
Inclusion Criteria

• Receiving an intrathecal baclofen trial (single shot baclofen test or
external intrathecal baclofen pump implantation) or permanent intrathecal
baclofen pump implantation
• Unilateral or bilateral spasticity of lower limbs
• Modified Ashworth Scale and electromyography measurements possible (18,5 *
BMI < 30)
• Able to understand and comply to verbal instructions

Exclusion Criteria

• Age under 18 years old
• High sensitivity of lower limb skin

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study endpoint is the change in muscle activity measured by EMG. The<br /><br>change in muscle activity is assessed by analysis of the amplitude, the root<br /><br>mean square, the power spectral density and the co-contraction index of the EMG<br /><br>signals. The EMG signals are measured during rest, during the MAS assessment<br /><br>and during voluntary contraction by the participant. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary study parameters are the MAS indices of the participants before and<br /><br>after ITB treatment and the Patient Global Impression of Change reported by the<br /><br>participants, and the correlation between de EMG features and MAS and PGIC.</p><br>
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