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Arm Motor Control on Bi and Uni ADLs (BiAs)

Primary Purpose

Stroke, Peripheral Neuropathy, Spinal Cord Injuries

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bilateral assessment robots (BiAS)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring stroke, amputees, spinal cord injuries, cerebral palsy, robotics, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Penn Medicine Rittenhouse

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Upper Limb Assessment on ADLs

Arm Description

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

Outcomes

Primary Outcome Measures

Interlimb Coordination
Kinematic Variables of Movement Overlap and Phase Difference
Movement Time
time to complete a task

Secondary Outcome Measures

Gross Finger Dexterity
Box and Block assessment
Sensory Nerve Deficits
Pin and Prick assessment
Grip strength
Grip Dynamometer measurement of strength
Movement Smoothness
Jerkiness on a task

Full Information

First Posted
March 30, 2016
Last Updated
September 6, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02778529
Brief Title
Arm Motor Control on Bi and Uni ADLs
Acronym
BiAs
Official Title
Insights Into Impaired Arm Motor Control on Bilateral and Unilateral Functional Activities After Injury: A Kinematic Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Equipment Failure
Study Start Date
May 2014 (Actual)
Primary Completion Date
September 2023 (Actual)
Study Completion Date
September 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Peripheral Neuropathy, Spinal Cord Injuries, Cerebral Palsy
Keywords
stroke, amputees, spinal cord injuries, cerebral palsy, robotics, rehabilitation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Upper Limb Assessment on ADLs
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Bilateral assessment robots (BiAS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Interlimb Coordination
Description
Kinematic Variables of Movement Overlap and Phase Difference
Time Frame
up to 1 week
Title
Movement Time
Description
time to complete a task
Time Frame
up to 1 week
Secondary Outcome Measure Information:
Title
Gross Finger Dexterity
Description
Box and Block assessment
Time Frame
up to 1 week
Title
Sensory Nerve Deficits
Description
Pin and Prick assessment
Time Frame
up to 1 week
Title
Grip strength
Description
Grip Dynamometer measurement of strength
Time Frame
up to 1 week
Title
Movement Smoothness
Description
Jerkiness on a task
Time Frame
up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle J Johnson, PhD
Organizational Affiliation
Penn Medicine Rittenhouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Medicine Rittenhouse
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26737308
Citation
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.
Results Reference
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PubMed Identifier
21881901
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.
Results Reference
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Arm Motor Control on Bi and Uni ADLs

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