Arm Motor Control on Bi and Uni ADLs (BiAs)

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

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.

Study Overview

• Status: Terminated
• Conditions: Stroke; Cerebral Palsy; Spinal Cord Injuries; Peripheral Neuropathy
• Intervention / Treatment: Device: Bilateral assessment robots (BiAS)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146
      • Penn Medicine Rittenhouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interlimb Coordination	Kinematic Variables of Movement Overlap and Phase Difference	up to 1 week
Movement Time	time to complete a task	up to 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross Finger Dexterity	Box and Block assessment	up to 1 week
Sensory Nerve Deficits	Pin and Prick assessment	up to 1 week
Grip strength	Grip Dynamometer measurement of strength	up to 1 week
Movement Smoothness	Jerkiness on a task	up to 1 week

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Michelle J Johnson, PhD, Penn Medicine Rittenhouse

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: March 30, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimated): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; spinal cord injuries; cerebral palsy; robotics; amputees
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Brain Damage, Chronic; Neuromuscular Diseases; Trauma, Nervous System; Spinal Cord Diseases; Cerebral Palsy; Peripheral Nervous System Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 820251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO