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

NCT04207632 | Unknown DMC

• 1 other identifier: MMTF123
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Muscle tone measured using modified ashworth scale

  Baseline and 4 weeks post BoNT-A injection

• Passive range of motion

  Baseline and 4 weeks post BoNT-A injection

Study Arms (1)

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

Interventions

Botulinum toxin type A injection DRUG

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

Intervention

Eligibility Criteria

• Age: 5 Years - 99 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Elsass Foundation: collaborator
• Hvidovre University Hospital: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Dystonia; Muscle Spasticity; Brain Injuries

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Derek J Curtis, phd

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Derek J Curtis, phd

CONTACT

004538626683; derek.john.curtis@regionh.dk

Ingrid Poulsen, phd

CONTACT

ingrid.poulsen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post doctoral fellow

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: April 1, 2020
• Primary Completion: January 15, 2021
• Study Completion: April 1, 2021
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)