Quantifying Muscle Tone in Patients With Brain Injury - a Feasibility Study

Study Overview
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Brief Summary
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This project will determine the feasibility and validity of measuring elbow muscle flexor stiffness in a population of patients with sub-acute severe acquired brain injury using two measurement methods, the portable spasticity assessment device (PSAD) (Movotec, Charlottenlund, Denmark) and an ultrasound measurement called shear wave sonoelastography (SWE).

Detailed Description
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The purpose of this study is to investigate the feasibility and validity of measuring hypertonia in the elbow flexors of patients with severe acquired brain injury in their sub-acute rehabilitation and collect data to determine the necessary size for a definitive study to determine the clinimetrics of the test methods. The long-term goal is to establish a valid and clinically feasible method for physiotherapists to quantify muscle tone in patients with neurological disorders. The study hypotheses are: SWE, PSAD and Modified Ashworth Scale (MAS) measurements can be obtained for elbow flexion hypertonia in all patients (no missing data due to test procedure), SWE and PSAD have a moderate to good intra-day intra-tester reliability (ICC two-way mixed effects model with absolute agreement. ICC>0.5, Bland Altman) Passive muscle stiffness measured using the PSAD and SWE have a fair concurrent validity with MAS (Spearmans correlation >0.3) SWE and PSAD are responsive in measuring a reduction of the effect of routine clinical treatment of the hypertonic muscles with botulinum toxin type A (BTX-A) (paired T-test or Wilcoxon test, p>0.05)

Official Title
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Quantifying Muscle Tone in Patients With Brain Injury - a Feasibility Study

Conditions
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Treatment Outcome, Muscle Dystonia, Spasticity, Muscle, Muscle Tightness, Acquired Brain Injury, Muscle Tone Abnormalities

Intervention / Treatment
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* Drug: Botulinum toxin type A injection


Participation Criteria
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Eligibility Criteria
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The project will include five patients admitted to the clinic for highly specialised neurorehabilitation/TBI. Inclusion criteria for the patients are that they: Fulfil the normal clinical requirements for treatment with BTX-A in at least one of their elbow flexors, (have increased stiffness in at least one of their elbow flexors, MAS greater than 0), Have given the normal informed consent to routine clinical treatment with BTX-A, Have given written informed consent or that proxy consent has been obtained, to participate in the study Exclusion criteria for patients are that they: Are unable to cooperate with the measurements due to uncontrolled non-voluntary movements Cannot be positioned safely or comfortably for the measurements.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>The Group of patients will receive routine treatment of muscle hypertonia with botulinum toxin type A in their elbow flexors. | Drug: Botulinum toxin type A injection<br>* Ultrasound-guided BoNT-A injection in biceps brachii or brachialis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in resistance to elbow extension measured using the portable spasticity assessment device (PSAD) | The patient will be measured bilaterally using a PSAD.The PSAD utilises a load cell, gyroscopes and accelerometers and electromyography (EMG) and can measure full passive joint torque and joint angle together with corresponding muscle activity. A reduced passive moment in Nm when moving the joint indicates a reduced tissue stiffness. | Twice at baseline and 4 weeks post BoNT-A injection | 
| Change in muscle stiffness in the treated muscle(s) measured using the shear wave elastography (SWE) | The patient will be scanned using an ultrasound scanner with shear wave elastography in the treated muscle and the contralateral equivalent. A reduced speed of propgation of the shear waves in m per second indicates a reduced stiffness/tone in the muscle. | Twice at baseline and 4 weeks post BoNT-A injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle tone measured using modified ashworth scale | Following standard clinical tone assessment procedure. The scale is from 0 to 4, where a lower value is indicative of a more normal muscle tone. | Baseline and 4 weeks post BoNT-A injection | 
| Passive range of motion | Passive range of motion in flexion and extension of the elbow joint will be measured. A normal range of motion is associated with normal muscle tone. A reduced range of motion can indicate increased muscle tone. | Baseline and 4 weeks post BoNT-A injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shear wave elastography, Portable spasticity assessment device, Feasibility, Outcome measure, Reliability, Validity, Clinimetrics