Treatment OutcomeNCT04207632
Quantifying Muscle Tone in Patients With Brain Injury - a Feasibility Study
An observational study of Treatment Outcome and Muscle Dystonia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 5 to 99 years
- Conditions the study is for
- Treatment Outcome, Muscle Dystonia, Spasticity, Muscle
- What is being tested?
- Botulinum toxin type A injection
- Type of treatment
- Injection or infusion
- How many people
- 5 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2020to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 99 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- Are unable to cooperate with the measurements due to uncontrolled non-voluntary movements
- Cannot be positioned safely or comfortably for the measurements.
Trial locations and contacts
1 site in 1 country.
Ingrid Poulsen, phd contact
About this study
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).
Read the 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)
- Conditions
- Treatment Outcome, Muscle Dystonia, Spasticity, Muscle, Muscle Tightness, Acquired Brain Injury, Muscle Tone Abnormalities
- Being tested
- Botulinum toxin type A injection
- Keywords
- Shear wave elastography, Portable spasticity assessment device, Feasibility, Outcome measure, Reliability, Validity, Clinimetrics
- Medical subject headings
- Dystonia, Muscle Spasticity, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A injectionDrug
Ultrasound-guided BoNT-A injection in biceps brachii or brachialis
| Study group | Role | What they receive |
|---|---|---|
| Intervention | The Group of patients will receive routine treatment of muscle hypertonia with botulinum toxin type A in their elbow flexors. Receives: Drug: Botulinum toxin type A injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Twice at baseline and 4 weeks post BoNT-A injection
Secondary outcomes (2)
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.
Measured: Baseline and 4 weeks post BoNT-A injection
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.
Measured: Baseline and 4 weeks post BoNT-A injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start1 Apr 2020 (estimated)
- Primary completion15 Jan 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment OutcomeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Elsass Foundation, Hvidovre University Hospital
- Responsible party
- Principal investigator, Derek Curtis, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Derek J Curtis, phd, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207632
- Sponsor's protocol ID
- MMTF123
- Status last verified
- Feb 2020
- First submitted
- 19 Dec 2019
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to European data regulations
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Muscle Tone in Patients With Brain Injury - a Feasibility Study
- ClinicalTrials.gov ID
- NCT04207632
- Acronym / sponsor ID
- MMTF123
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Elsass Foundation, Hvidovre University Hospital
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Drug: Botulinum toxin type A injectionThe Group of patients will receive routine treatment of muscle hypertonia with botulinum toxin type A in their elbow flexors. |
Who may qualify
- Ages
- 5 to 99 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Are unable to cooperate with the measurements due to uncontrolled non-voluntary movements
- Cannot be positioned safely or comfortably for the measurements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type A injectionUltrasound-guided BoNT-A injection in biceps brachii or brachialis | Drug | Intervention |
Primary outcome
Change in resistance to elbow extension measured using the portable spasticity assessment device (PSAD)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Muscle tone measured using modified ashworth scale
Time frame: Baseline and 4 weeks post BoNT-A injection
Passive range of motion
Time frame: Baseline and 4 weeks post BoNT-A injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Individual participant dataSharing planned: No. IPD will not be shared due to European data regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid Poulsen, phd contact
Derek J Curtis, phd principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Outcome and Muscle Dystonia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Derek J Curtis, phd (004538626683, derek.john.curtis@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resistance to elbow extension measured using the portable spasticity assessment device (PSAD) (time frame: Twice at baseline and 4 weeks post BoNT-A injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.