None listed
Conditions
Brief summary
Spasticity is a common sequelae following stroke with prevalence rates of 30-80%. Patients experiencing upper limb spasticity report reduced quality of life secondary to difficulties using their arm for daily tasks and pain. Valid and reliable assessments for spasticity are critical for the selection and evaluation of treatments. Clinical scales are the most common method for assessing upper limb spasticity following a stroke, and include the Modified Ashworth Scale (MAS) and the Modified Tardieu Scale (MTS). More recently, robotic devices and information technology have been found to be safe and effective in increasing the efficiency of care, including objectively measuring impairments. We hypothesise that a robotic device will provide a more accurate and reliable measure of spasticity than existing clinical scales. This study aims to compare reliability between the robotic device and the two clinical measures, the MAS and MTS, in assessing spasticity in the elbow flexors of stroke survivors. Participants’ affected upper limb will be passively moved from flexion to extension using different speeds. This study will take place at the Royal Melbourne Hospital, in Australia.
Interventions
This study aims to evaluate the test-retest reliability of a robotic device to accurately identify at what velocity spasticity is triggered, and to determine the concurrent validity of the robotic device with the most commonly used clinical assessments for spasticity, the modified Tardieu Scale and the Modified Ashworth Scale.
Patients will undertake two trials with the robotic device (described below) and clinical measures of spasticity. Each trial will last 20 minutes and the patient will have
This study aims to evaluate the test-retest reliability of a robotic device to accurately identify at what velocity spasticity is triggered, and to determine the concurrent validity of the robotic device with the most commonly used clinical assessments for spasticity, the modified Tardieu Scale and the Modified Ashworth Scale. Patients will undertake two trials with the robotic device (described below) and clinical measures of spasticity. Each trial will last 20 minutes and the patient will have a 10 minute break between trials. A maximum time of 60 minutes will be allocated to the trial. a) Robotic device description - this study uses the M2 (Fourier Intelligence), a robotic device that is commercially available and registered with TGA. The device is a planar manipulandum which attaches to the hand of the patient with forearm support. As such it is able to passively move the participant's hand / arm in the transverse plane. The device comes up with a user interface on a computer screen which includes a number of options such as rehabilitation activities and assessment options. b) Administration - an AHPRA registered occupational therapist with significant expertise in neurological rehabilitation will be responsible for conducting the clinical scales and setting the patient up on the M2 for the robotic measures. An engineer will be present during the robotic measure phase. c) Mode of delivery - individual d) Velocity - the robotic device will passively flex and extend the patient's elbow through a maximum range of 80 degrees. Patients commence with elbow flexed to 90 degrees (shortened flexors) and the robot passively extends at a velocity of 10 cm per second. This procedure is completed at increasing velocities of 10 cm per second up to a maximum of 80 cm per second i.e. velocities will be 10 cm/s, 20 cm/s, 30 cm/s, 40 cm/s, 50 cm/s, 60 cm/s, 70 cm/s and 80 cm/s. The trial ceases when the patient exhibits a resistance force at higher than 80 Newton.
Sponsors
Melbourne Health
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Hemiparesis due to a unilateral single clinical stroke Spasticity in the elbow flexors Able to give informed consent
Exclusion criteria
Co-morbid neurological conditions Recent <6 months pharmacological treatment for spasticity including botulinum toxin and baclofen Painful shoulder Significant upper limb pathology e.g. osteoarthritis Inability to follow a single-stage command Presence of contractures in the affected upper limb
Outcome results
None listed