NCT02778529

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

9.3 years

First QC Date

March 30, 2016

Last Update Submit

September 6, 2023

Conditions

StrokePeripheral NeuropathySpinal Cord InjuriesCerebral Palsy

Keywords

strokeamputeesspinal cord injuriescerebral palsyroboticsrehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Gross Finger Dexterity

    up to 1 week

  • Sensory Nerve Deficits

    up to 1 week

  • Grip strength

    up to 1 week

  • Movement Smoothness

    up to 1 week

Study Arms (1)

Upper Limb Assessment on ADLs

OTHER

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)

Interventions

Bilateral assessment robots (BiAS)DEVICE

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.

Upper Limb Assessment on ADLs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn Medicine Rittenhouse

Philadelphia, Pennsylvania, 19146, United States

Location

Related 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.

    PMID: 26737308BACKGROUND

  • 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.

    PMID: 21881901BACKGROUND

MeSH Terms

Conditions

StrokePeripheral Nervous System DiseasesSpinal Cord InjuriesCerebral Palsy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeuromuscular DiseasesSpinal Cord DiseasesTrauma, Nervous SystemWounds and InjuriesBrain Damage, Chronic

Study Officials

  • Michelle J Johnson, PhD

    Penn Medicine Rittenhouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2016

First Posted

May 20, 2016

Study Start

May 1, 2014

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 8, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)