The General Use of Robots in Stroke Recovery

NCT ID: NCT01726660

Last Updated: 2018-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

IMT Robotic Arm therapy

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

IMT Robotic Arm therapy

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

IMT Robotic Arm therapy

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

IMT Robotic Arm therapy

Intervention Type DEVICE

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

Interventions

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IMT Robotic Arm therapy

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Bruce Volpe

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce T Volpe, MD

Role: PRINCIPAL_INVESTIGATOR

Feinstein Institute for Medical Research

Locations

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Feinstein Institute for Medical Research

Manhasset, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15314537 (View on PubMed)

Other Identifiers

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11-121B

Identifier Type: -

Identifier Source: org_study_id

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