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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Unknown status

CT.gov ID

NCT04207632

Collaborator

Elsass Foundation (Other), Hvidovre University Hospital (Other)

Enrollment

Location

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Treatment Outcome Muscle Dystonia Spasticity, Muscle Muscle Tightness Acquired Brain Injury Muscle Tone Abnormalities	Drug: Botulinum toxin type A injection

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:

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)

Study Design

Study Type:

Observational

Anticipated Enrollment :

5 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Jan 15, 2021

Anticipated Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Intervention 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 Ultrasound-guided BoNT-A injection in biceps brachii or brachialis

Arm

Intervention/Treatment

Intervention

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

Ultrasound-guided BoNT-A injection in biceps brachii or brachialis

Outcome Measures

Primary Outcome Measures

Change in resistance to elbow extension measured using the portable spasticity assessment device (PSAD) [Twice at baseline and 4 weeks post BoNT-A injection]
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.
Change in muscle stiffness in the treated muscle(s) measured using the shear wave elastography (SWE) [Twice at baseline and 4 weeks post BoNT-A injection]
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.

Secondary Outcome Measures

Muscle tone measured using modified ashworth scale [Baseline and 4 weeks post BoNT-A injection]
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.
Passive range of motion [Baseline and 4 weeks post BoNT-A injection]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 99 Years

Sexes Eligible for Study:

All

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.