Acquired Brain Injury Clinical Trial
Official title:
Quantifying Muscle Tone in Patients With Brain Injury - a Feasibility 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).
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)
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03911752 -
Approach to Sexuality From Occupational Therapy in People With Acquired Brain Injury in Subacute Stage
|
||
Completed |
NCT05265377 -
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
|
N/A | |
Not yet recruiting |
NCT05863897 -
e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury
|
N/A | |
Completed |
NCT02215590 -
Re-Step: Dynamic Balance Treatment of Gait for Acquired Brain Injury (ABI) Victims
|
N/A | |
Recruiting |
NCT05443542 -
VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI
|
N/A | |
Recruiting |
NCT05309005 -
Virtual Reality and Social Cognition After Acquired Brain Injury
|
||
Recruiting |
NCT04586842 -
Community-based Occupational Therapy Intervention on Mental Health for People With Acquired Brain Injury
|
N/A | |
Completed |
NCT03328221 -
Physical Activity on Heart Rate Variability in Patients With Severe Acquired Brain Injury
|
||
Active, not recruiting |
NCT05734183 -
Multisensorial IMmersive Experiences (MIME) in Disorders of Consciousness
|
N/A | |
Active, not recruiting |
NCT05729165 -
Local Vibration in Patients With Severe Acquired Brain Injury
|
N/A | |
Recruiting |
NCT05440682 -
Connectivity in Cranioplasty
|
N/A | |
Completed |
NCT04206475 -
Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School Aged Children With Acquired br.Inj.
|
N/A | |
Recruiting |
NCT02495558 -
Cough Assessment in Patients With Severe Acquired Brain Injury
|
N/A | |
Completed |
NCT03989388 -
Occupational Self-Analysis Programme
|
N/A | |
Terminated |
NCT01974635 -
Proprioception Testing in Persons With Sensorimotor Impairment
|
N/A | |
Not yet recruiting |
NCT01451242 -
The Reliability of Heart Rate Variability Among Patients With Brain Injury as Measured by POLAR RC810XE Compared to HOLTER
|
N/A | |
Completed |
NCT05052905 -
VR-based Remote Rehabilitation for Pediatric ABI
|
N/A | |
Recruiting |
NCT06130735 -
Impact of Intensive Computerized Cognitive Training
|
N/A | |
Recruiting |
NCT04328857 -
Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing
|
N/A | |
Completed |
NCT04499092 -
COgnitive REhabilitation in Pediatric Patients With sABI From Vegetative State to Functional Recovery
|
N/A |