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

Acquired Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04207632
• Other study ID #: MMTF123
• Status: Not yet recruiting
• Start date: April 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: February 2020
• Source: Rigshospitalet, Denmark
• Contact: Derek J Curtis, phd
• Phone: 004538626683
• Email: derek.john.curtis[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: April 1, 2021
• Est. primary completion date: January 15, 2021
• Gender: All
• Age group: 5 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Dystonia
• Muscle Dystonia
• Muscle Spasticity
• Muscle Tightness
• Muscle Tone Abnormalities
• Spasticity, Muscle
• Treatment Outcome
• Wounds and Injuries

Intervention

Drug:
• Botulinum toxin type A injection
Ultrasound-guided BoNT-A injection in biceps brachii or brachialis

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Elsass Foundation, Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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