Arm Motor Control on Bi and Uni ADLs (BiAs)
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|ClinicalTrials.gov Identifier: NCT02778529|
Recruitment Status : Recruiting
First Posted : May 20, 2016
Last Update Posted : January 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke Peripheral Neuropathy Spinal Cord Injuries Cerebral Palsy||Device: Bilateral assessment robots (BiAS)||Not Applicable|
Cross-sectional study comparing bilateral ADL activities for stroke survivors, SCI paraplegics, UE amputees, adults with CP, and healthy controls. The study participants will perform 4 ADL tasks with the BiAS passive robots. From these tasks, the BiAS robots will provide information regarding position, velocity, distance, displacement, etc. This, along with video information provided by the 3D Kinect and EEG neuroheadset, will be used as the basis of the investigators data and aid in informing members of the research team on how the respective impairments affected upper limb kinematics on ADL tasks.
Participation in the study will include the following steps:
- Informed Consent: After arrival, subjects will review and sign the consent form with study personnel present.
- Pre-Assessments: A member of the research team will evaluate the subjects' upper extremity and assess their ability to use it. Subjects will be evaluated using a battery of assessments such as, but not limited to, the Box and Block, Pin and Prick, and grip strength using a dynamometer.
- Break: Subjects will be given a 15 minute break.
- BiAS passive robot system: Subjects will be introduced to the device and each wrist will be placed on to the end of each robot. As common therapy tasks are performed by the subject, the BiAS devices will collect the data along with the video from 3D Kinect, ECG gelled electrodes, and the EEG neuroheadset. After each of the 4 ADL activities, subjects will be asked about their level of exercise and discomfort, if any. After subjects finish all exercises with the BiAS, they will be thanked for their participation in the study.
- Video and photos may be collected to determine subject quality of ADL movement.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Insights Into Impaired Arm Motor Control on Bilateral and Unilateral Functional Activities After Injury: A Kinematic Study|
|Actual Study Start Date :||May 2014|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||August 2019|
Upper Limb Assessment on ADLs
Bilateral assessment robots (BiAS) Evaluate upper limb kinematics of Stroke, Amputees, SCI, Cerebral Palsy and Health Subjects will be assessed as they complete unilateral and bilateral activities of daily living. Subjects will complete exercises in 1 session
Device: Bilateral assessment robots (BiAS)
The BiAS are two passive desktop robots that will be used in this study to measure right and left arm kinematics for 4 different groups of patients.
- Interlimb Coordination [ Time Frame: up to 1 week ]Kinematic Variables of Movement Overlap and Phase Difference
- Movement Time [ Time Frame: up to 1 week ]time to complete a task
- Gross Finger Dexterity [ Time Frame: up to 1 week ]Box and Block assessment
- Sensory Nerve Deficits [ Time Frame: up to 1 week ]Pin and Prick assessment
- Grip strength [ Time Frame: up to 1 week ]Grip Dynamometer measurement of strength
- Movement Smoothness [ Time Frame: up to 1 week ]Jerkiness on a task
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778529
|Contact: Megan A Johnson, BS||215-893-2679||Megan.Johnson@uphs.upenn.edu|
|Contact: Roshan Rai, MS||215-893-2689||Roshan.Rai@uphs.upenn.edu|
|United States, Pennsylvania|
|Penn Medicine Rittenhouse||Recruiting|
|Philadelphia, Pennsylvania, United States, 19146|
|Principal Investigator:||Michelle J Johnson, PhD||Penn Medicine Rittenhouse|