Acquired Brain Injury Clinical Trial
Official title:
Quantifying Muscle Tone in Patients With Brain Injury - a Feasibility Study
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).
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:
1. 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),
2. 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)
3. Passive muscle stiffness measured using the PSAD and SWE have a fair concurrent validity
with MAS (Spearmans correlation >0.3)
4. 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)
;
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