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

• Conditions: Muscle Dystonia; Muscle Tone Abnormalities; Spasticity, Muscle; Muscle Tightness; Treatment Outcome; Acquired Brain Injury
• Interventions: Drug: Botulinum toxin type A injection

• Registration Number: NCT04207632
• Lead Sponsor: Rigshospitalet, Denmark

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)

Study Timeline

• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-23
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26
• Study Start: 2020-04-01
• Primary Completion: 2021-01-15
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	Botulinum toxin type A injection	The Group of patients will receive routine treatment of muscle hypertonia with botulinum toxin type A in their elbow flexors.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark