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| Name | Class |
|---|---|
| Elsass Foundation | OTHER |
| Hvidovre University Hospital | OTHER |
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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | The Group of patients will receive routine treatment of muscle hypertonia with botulinum toxin type A in their elbow flexors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A injection | Drug | Ultrasound-guided BoNT-A injection in biceps brachii or brachialis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Passive range of motion |
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The project will include five patients admitted to the clinic for highly specialised neurorehabilitation/TBI. Inclusion criteria for the patients are that they:
Exclusion criteria for patients are that they:
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Patients hospitalised for intensive rehabilitation following severe traumatic brain injury with hypertonia in their elbow flexors requirng routine treatment with BoNT-A injection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Derek J Curtis, phd | Contact | 004538626683 | derek.john.curtis@regionh.dk | |
| Ingrid Poulsen, phd | Contact | ingrid.poulsen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Derek J Curtis, phd | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark |
IPD will not be shared due to European data regulations
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| ID | Term |
|---|---|
| D004421 | Dystonia |
| D009128 | Muscle Spasticity |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |