Arm Motor Control on Bi and Uni ADLs (BiAs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02778529
Recruitment Status : Recruiting
First Posted : May 20, 2016
Last Update Posted : January 11, 2019
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Stroke Peripheral Neuropathy Spinal Cord Injuries Cerebral Palsy Device: Bilateral assessment robots (BiAS) Not Applicable

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  (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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cerebral Palsy

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Interlimb Coordination [ Time Frame: up to 1 week ]
    Kinematic Variables of Movement Overlap and Phase Difference

  2. Movement Time [ Time Frame: up to 1 week ]
    time to complete a task

Secondary Outcome Measures :
  1. Gross Finger Dexterity [ Time Frame: up to 1 week ]
    Box and Block assessment

  2. Sensory Nerve Deficits [ Time Frame: up to 1 week ]
    Pin and Prick assessment

  3. Grip strength [ Time Frame: up to 1 week ]
    Grip Dynamometer measurement of strength

  4. Movement Smoothness [ Time Frame: up to 1 week ]
    Jerkiness on a task

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02778529

Contact: Megan A Johnson, BS 215-893-2679
Contact: Roshan Rai, MS 215-893-2689

United States, Pennsylvania
Penn Medicine Rittenhouse Recruiting
Philadelphia, Pennsylvania, United States, 19146
Sponsors and Collaborators
University of Pennsylvania
Principal Investigator: Michelle J Johnson, PhD Penn Medicine Rittenhouse

Responsible Party: University of Pennsylvania Identifier: NCT02778529     History of Changes
Other Study ID Numbers: 820251
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Pennsylvania:
spinal cord injuries
cerebral palsy

Additional relevant MeSH terms:
Spinal Cord Injuries
Cerebral Palsy
Peripheral Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic
Brain Diseases
Neuromuscular Diseases