The General Use of Robots in Stroke Recovery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by North Shore Long Island Jewish Health System
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01726660
First received: October 26, 2012
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Stroke
Device: IMT Robotic Arm therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of the Effects of Protocol-Specific Robotic Arm Therapy in Stroke Recovery

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Kinematic Data [ Time Frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention) ] [ Designated as safety issue: No ]
    Kinematic Data recorded during therapy with IMT robots

  • Change from baseline in Fugl Meyer Sensation Scale [ Time Frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention) ] [ Designated as safety issue: No ]
  • Change from baseline in Fugl Meyer Proprioception Scale [ Time Frame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention) ] [ Designated as safety issue: No ]

Estimated Enrollment: 176
Study Start Date: September 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726660

Contacts
Contact: Bruce T Volpe, MD 516-562-3384 bvolpe1@nshs.edu
Contact: Johanna Chang, MS 516-562-3646 jchang14@nshs.edu

Locations
United States, New York
Feinstein Institute for Medical Research Not yet recruiting
Manhasset, New York, United States, 11030
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Bruce T Volpe, MD Feinstein Institute for Medical Research
  More Information

Publications:
Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01726660     History of Changes
Other Study ID Numbers: 11-121B
Study First Received: October 26, 2012
Last Updated: January 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Stroke
Cerebrovascular Accident
Cerebral stroke
CVA
robotic therapy
upper extremity recovery
kinematic training

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 20, 2014