Assessment of Upper Limb Motor Performance Using an Interface With Haptic Feedback
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Movement smoothness
Study Overview
Brief Summary
The purpose of the study is to test an evaluation environment based on a device that has the ability to provide the user with tactile (haptic) sensations. This environment will be used to investigate how the arm movements of a healthy person are performed, and then - at a later stage - to find out whether it is possible to measure changes during musculoskeletal pain. Electrical signals produced by the brain (called electroencephalogram or EEG) will be recorded by means of electrodes on the surface of the scalp (non-invasive). In addition, the angle of the elbow joint during movement will be measured, with the intention of using objective measures to aid future evidence-based clinical decision making.
It is expected that the developed environment can be used -in the near future-, to evaluate the progression of pathologies associated with muscle pain, or to quantify the effectiveness of rehabilitation therapies.
Detailed Description
Experimental setup Volunteers will be received at the Center of Rehabilitation Engineering and Neuromuscular and Sensory Research (CIRINS). They will be informed, in simple terms, of the purpose of the project and the measurements that will be done during the session. The Informed Consent Form will be read to each volunteer and, if they decide to participate, they will be asked to sign a copy that will be filed in the Laboratory together with their contact information, which will be stored confidentially.
At the beginning of the session, the volunteer will be asked to sit comfortably. The EEG electrodes will then be attached using a 16-electrode cap in the standard 10-20 location, together with the exoskeleton in the position determined by the investigator. The position of the camera that will be used to follow the movements of the upper limb will also be adjusted to ensure that the movements will be within the camera's field of view.
Subsequently, the subject will be placed in its initial position: seated, with approximately 45° of shoulder abduction, 10° of shoulder flexion and 90° of elbow flexion.
Once the subject is in the proper position, they will be asked, using the implemented test interface, to perform the virtual nine-hole peg test (NHPT) in Cue Based and Self Paced variants. The volunteer will be asked to complete these tests with both hands, in order to assess whether there are differences in performance associated with the side with which the test is performed, and whether using the system is sensitive enough to detect these changes. The researcher conducting the experiment should record which test was performed with the dominant hand and which was not.
To evaluate whether the results obtained are satisfactory, they will be compared with those reported for healthy individuals.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •No history of neurological disease, chronic pain, or musculoskeletal disorders.
- •Willingness and ability to fully understand the content and scope of the experiment and to comply with the instructions.
- •Signature of the informed consent document.
Exclusion Criteria
- •Pregnancy.
- •History of chronic pain or neuromuscular disorders.
- •History of addictive behavior, defined as abuse of alcohol, cannabis, opioids or other drugs.
- •History of heat sensitivity disorders.
- •Presence of fever, tuberculosis, malignant tumors, infectious processes, acute inflammatory processes.
- •Implantation of pacemakers or metallic prostheses.
- •Use of analgesics within 24 hours prior to participation in the experiment.
- •Lack of cooperation.
- •Trauma of the segment to be evaluated in the last 4 weeks.
- •Surgical history of the upper quadrant.
- •Metabolic diseases.
- •Ingestion of pain medication in the last 24 hs.
Outcomes
Primary Outcomes
Movement smoothness
Time Frame: Average of 36 trials during a single experimental session with a duration of 30 minutes
Smoothness of the participant movement calculated through the fourth derivative of the trajectory (jerk).
Secondary Outcomes
- Path length ratio transport(Average of 36 trials during a single experimental session with a duration of 30 minutes)
- Velocity max. return(Average of 36 trials during a single experimental session with a duration of 30 minutes)
- Jerk peg approach(Average of 36 trials during a single experimental session with a duration of 30 minutes)
- Log jerk return(Average of 36 trials during a single experimental session with a duration of 30 minutes)
- Path length ratio return(Average of 36 trials during a single experimental session with a duration of 30 minutes)
- Log jerk transport(Average of 36 trials during a single experimental session with a duration of 30 minutes)
- SPARC return(Average of 36 trials during a single experimental session with a duration of 30 minutes)
Investigators
Rosa María Weisz
Principal Investigator
Universidad Nacional de Entre Rios