BiAs: Arm Motor Control on Bi and Uni ADLs

Sponsor
University of Pennsylvania (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02778529
Collaborator
(none)
30
1
1
96
0.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Bilateral assessment robots (BiAS)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
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 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Interlimb Coordination [up to 1 week]

    Kinematic Variables of Movement Overlap and Phase Difference

  2. Movement Time [up to 1 week]

    time to complete a task

Secondary Outcome Measures

  1. Gross Finger Dexterity [up to 1 week]

    Box and Block assessment

  2. Sensory Nerve Deficits [up to 1 week]

    Pin and Prick assessment

  3. Grip strength [up to 1 week]

    Grip Dynamometer measurement of strength

  4. Movement Smoothness [up to 1 week]

    Jerkiness on a task

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Penn Medicine Rittenhouse Philadelphia Pennsylvania United States 19146

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

  • Principal Investigator: Michelle J Johnson, PhD, Penn Medicine Rittenhouse

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02778529
Other Study ID Numbers:
  • 820251
First Posted:
May 20, 2016
Last Update Posted:
Jun 23, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2021