Arm Motor Control on Bi and Uni ADLs

Stroke Clinical Trial

— BiAs  

Official title:

Insights Into Impaired Arm Motor Control on Bilateral and Unilateral Functional Activities After Injury: A Kinematic Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02778529
• Other study ID #: 820251
• Status: Terminated
• Phase: N/A
• Start date: May 2014
• Est. completion date: September 2023

Study information

• Verified date: September 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being performed to assess how certain chronic disabilities - stroke, upper extremity (UE) amputation, spinal cord injuries (SCI), cerebral palsy (CP) - differ from healthy subjects in their ability to perform ADLs. By studying the kinematics of the respective cohort of study participants as they are assessed performing common activities of daily living (ADLS), the investigators research team aims to better understand how impaired neural pathways, and pathways that have been impaired at various points along the pathway, deleteriously affect ADLs in patients with differing long-term disabilities.

Description:

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:

1. Informed Consent: After arrival, subjects will review and sign the consent form with study personnel present.

2. 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.

3. Break: Subjects will be given a 15 minute break.

4. 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.

5. Video and photos may be collected to determine subject quality of ADL movement.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Study will include subjects 18 years of age or older from any of the below groups:

• Stroke survivors, 3 months post event

• Upper extremity amputees, 3 months post event

• Cervical SCI (C-5 to C-7), 3 months post event

• Cerebral palsy participants

• Healthy participants

Exclusion Criteria:

• The inability to perform at least some aspects of ADL tasks such as drinking, pouring, pinching, and grasping.

• Severe spasticity

Related Conditions & MeSH terms

• Cerebral Palsy
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Spinal Cord Injuries
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Penn Medicine Rittenhouse	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (2)

Dimwamwa E, Johnson MJ. Kinematic analysis of unilateral and bilateral drinking task after brain and periphery injuries. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:4558-61. doi: 10.1109/EMBC.2015.7319408. — View Citation

Johnson MJ, Wang S, Bai P, Strachota E, Tchekanov G, Melbye J, McGuire J. Bilateral assessment of functional tasks for robot-assisted therapy applications. Med Biol Eng Comput. 2011 Oct;49(10):1157-71. doi: 10.1007/s11517-011-0817-0. Epub 2011 Sep 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interlimb Coordination	Kinematic Variables of Movement Overlap and Phase Difference	up to 1 week
Primary	Movement Time	time to complete a task	up to 1 week
Secondary	Gross Finger Dexterity	Box and Block assessment	up to 1 week
Secondary	Sensory Nerve Deficits	Pin and Prick assessment	up to 1 week
Secondary	Grip strength	Grip Dynamometer measurement of strength	up to 1 week
Secondary	Movement Smoothness	Jerkiness on a task	up to 1 week