NCT01726660

Brief Summary

The purpose of this study is to determine if tailoring multiple sessions of upper extremity robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming; active range of motion vs. functional practice)can optimize therapeutic results and lead to greater functional returns in arm mobility after stroke.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

3.8 years

First QC Date

October 26, 2012

Last Update Submit

February 2, 2018

Conditions

Stroke

Keywords

StrokeCerebrovascular AccidentCerebral strokeCVArobotic therapyupper extremity recoverykinematic training

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Upper Extremity Fugl Meyer Motor Assessment

    12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)

Secondary Outcomes (3)

  • Change from baseline in Kinematic Data

    12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)

  • Change from baseline in Fugl Meyer Sensation Scale

    12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)

  • Change from baseline in Fugl Meyer Proprioception Scale

    12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)

Study Arms (4)

IMT Robotic Arm Therapy: Aim training

EXPERIMENTAL

Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for aim training, 3x/week for 12 weeks.

Device: IMT Robotic Arm therapy

IMT Robotic Arm Therapy: Smoothness Training

EXPERIMENTAL

Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for smoothness training, 3x/week for 12 weeks.

Device: IMT Robotic Arm therapy

IMT Robotic Arm Therapy: Impairment training

EXPERIMENTAL

Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole-arm, impairment training, 3x/week for 12 weeks.

Device: IMT Robotic Arm therapy

IMT Robotic Arm Therapy: Functional training

EXPERIMENTAL

Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole arm, functional training, 3x/week for 12 weeks.

Device: IMT Robotic Arm therapy

Interventions

IMT Robotic Arm therapyDEVICE

Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy

IMT Robotic Arm Therapy: Aim trainingIMT Robotic Arm Therapy: Functional trainingIMT Robotic Arm Therapy: Impairment trainingIMT Robotic Arm Therapy: Smoothness Training

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
  • Cognitive function sufficient enough to understand experiments and follow instructions
  • Fugl Meyer assessment at admission of 7 to 38 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)

You may not qualify if:

  • Prior experience with robotic arm therapy
  • Fixed contraction of the affected limb
  • Complete flaccid paralysis of the affected limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Related Publications (1)

  • Stein J, Krebs HI, Frontera WR, Fasoli SE, Hughes R, Hogan N. Comparison of two techniques of robot-aided upper limb exercise training after stroke. Am J Phys Med Rehabil. 2004 Sep;83(9):720-8. doi: 10.1097/01.phm.0000137313.14480.ce.

    PMID: 15314537BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bruce T Volpe, MD

    Feinstein Institute for Medical Research

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2012

First Posted

November 15, 2012

Study Start

February 1, 2012

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

US(1)