Clinical trial NCT04207632: Quantifying Muscle Tone in Patients With Brain Injury - a Feasibility Study
Official title: Quantifying Muscle Tone in Patients With Brain Injury - a Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Treatment Outcome
Muscle Dystonia
Spasticity, Muscle
Muscle Tightness
Acquired Brain Injury
Muscle Tone Abnormalities
Keywords: Shear wave elastography
Portable spasticity assessment device
Feasibility
Outcome measure
Reliability
Validity
Clinimetrics
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Elsass Foundation
name: Hvidovre University Hospital
First posted: 2019-12-23
Enrollment: 5
Sex: ALL
Minimum age (years): 5
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalised for intensive rehabilitation following severe traumatic brain injury with hypertonia in their elbow flexors requirng routine treatment with BoNT-A injection.

Brief summary: 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: 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)

Eligibility criteria: The project will include five patients admitted to the clinic for highly specialised neurorehabilitation/TBI. Inclusion criteria for the patients are that they:

1. 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),
2. Have given the normal informed consent to routine clinical treatment with BTX-A,
3. Have given written informed consent or that proxy consent has been obtained, to participate in the study

Exclusion criteria for patients are that they:

1. Are unable to cooperate with the measurements due to uncontrolled non-voluntary movements
2. Cannot be positioned safely or comfortably for the measurements.

Primary outcomes:
measure: Change in resistance to elbow extension measured using the portable spasticity assessment device (PSAD)
timeFrame: Twice at baseline and 4 weeks post BoNT-A injection
measure: Change in muscle stiffness in the treated muscle(s) measured using the shear wave elastography (SWE)
timeFrame: Twice at baseline and 4 weeks post BoNT-A injection
Secondary outcomes:
measure: Muscle tone measured using modified ashworth scale
timeFrame: Baseline and 4 weeks post BoNT-A injection
measure: Passive range of motion
timeFrame: Baseline and 4 weeks post BoNT-A injection
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Derek J Curtis, phd
role: PRINCIPAL_INVESTIGATOR
References: