The General Use of Robots in Stroke Recovery

February 2, 2018 updated by: Bruce Volpe, Northwell Health

Pilot Study of the Effects of Protocol-Specific Robotic Arm Therapy in Stroke Recovery

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Manhasset, New York, United States, 11030
        • Feinstein Institute for Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 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)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMT Robotic Arm Therapy: Aim training
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for aim training, 3x/week for 12 weeks.
Device: IMT Robotic Arm therapy
Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy
Experimental: IMT Robotic Arm Therapy: Smoothness Training
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for smoothness training, 3x/week for 12 weeks.
Device: IMT Robotic Arm therapy
Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy
Experimental: IMT Robotic Arm Therapy: Impairment training
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
Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy
Experimental: IMT Robotic Arm Therapy: Functional training
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
Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Upper Extremity Fugl Meyer Motor Assessment
Time Frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Kinematic Data
Time Frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Kinematic Data recorded during therapy with IMT robots
12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Change from baseline in Fugl Meyer Sensation Scale
Time Frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Change from baseline in Fugl Meyer Proprioception Scale
Time Frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Bruce T Volpe, MD, Feinstein Institute for Medical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 26, 2012

First Submitted That Met QC Criteria

November 9, 2012

First Posted (Estimate)

November 15, 2012

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 2, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-121B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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