Safety and Feasibility of an ExoNET for Supination Assistance for Stroke Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorShirley Ryan AbilityLab
About this trial
The purpose of this study is to evaluate the safety, feasibility, and efficacy of an exoskeletal network of passive, multi-joint springs for forearm supination. Also known as the forearm ExoNET, the device is a passive, robotic device that will properly assist forearm supination in the post-stroke adult population.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Between the ages of 40-70 (to reduce confounding effects of aging on muscle, movement accuracy and proprioception)
Have sustained a single, unilateral stroke at least 8 months prior to enrollment
Severe to moderate upper extremity impairment (ARAT score 0-30)
Ability to move their elbow and wrist when supported against gravity
Disqualifiers
Bilateral paresis
Diffuse/multiple lesion sites or multiple stroke events
Hemispatial neglect or visual field cut that prevent visual feedback
Shoulder pain and/or articular rigidity on the upper limb joint
Trial design
Design model
Crossover
Treatments tested in this trial
Device tuned to Assistance
DeviceThe device spring components will be tuned to produce an assistive supination torque on the forearm.
Device tuned to Sham (Slack Springs)
DeviceThe device spring components will be tuned to slack springs to serve as a placebo. The user will think they are receiving forces but in reality the device will not be providing any forces.
Device tuned to Anti-Assistance
DeviceThe device spring components will be tuned to produce a resistive supination torque on the forearm.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Group 1 - Assistance, Sham, Anti-AssistanceExperimental treatment 3 interventions
Group B: Group 2 - Sham, Assistance, Anti-AssistanceExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Action Research Arm Test (ARAT)
Observational measure used to assess change in upper extremity performance in individuals with a damaged nervous system
Time frame
Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)Secondary outcomes
1
Upper extremity portion of the Fugl-Meyer (FMUE)
Observational measure used to measure change in upper extremity impairment in individuals with a damaged nervous system
Time frame
Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)2
Box and Blocks
Measures change in unilateral gross motor dexterity
Time frame
Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)Other outcomes
1
Electromyography using Delsys
Delsys sensors will be used to measure change in biceps activity
Time frame
Treatment phases (week 1, week 2 and week 3)2
Joint Kinematics using Microsoft Kinect
Markerless joint tracking system will be used to collect changes in the joint kinematics to identify changes in limb movement compensatory strategies
Time frame
Treatment phases (week 1, week 2 and week 3)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov