Trials / Unknown
UnknownNCT04207632
Quantifying Muscle Tone in Patients With Brain Injury - a Feasibility Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 5 (estimated)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- All
- Age
- 5 Years – 99 Years
- Healthy volunteers
- —
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)
Conditions
- Treatment Outcome
- Muscle Dystonia
- Spasticity, Muscle
- Muscle Tightness
- Acquired Brain Injury
- Muscle Tone Abnormalities
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Botulinum toxin type A injection | Ultrasound-guided BoNT-A injection in biceps brachii or brachialis |
Timeline
- Start date
- 2020-04-01
- Primary completion
- 2021-01-15
- Completion
- 2021-04-01
- First posted
- 2019-12-23
- Last updated
- 2020-02-26
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04207632. Inclusion in this directory is not an endorsement.