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Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke (Robot3)

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status and phase

Completed
Phase 2

Conditions

Stroke

Treatments

Device: Hand & Wrist Assisting Robotic Device

Study type

Interventional

Funder types

Other

Identifiers

NCT01244243
HS#2004-3852

Details and patient eligibility

About

The purpose of this study is to develop and assess the effectiveness of robot-assisted movement therapy in enhancing hand motor function in subjects with chronic hemiparetic stroke, and to identify predictors of treatment response.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. At least 18 years old
  2. Had stroke between 11-26 weeks ago
  3. Have some weakness in one of your wrists or hands due to stroke
  4. Did not have too much disability prior to stroke
  5. Do not have major depression

Exclusion criteria

  1. Non-English speaking
  2. If you have trouble keeping good attention
  3. Pregnant, advanced liver, kidney, heart, or lung disease
  4. Terminal medical diagnosis or major neurological or psychiatric disease apart from stroke
  5. Cannot undergo MRI scanning
  6. Have history of brain surgery or seizures

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

41 participants in 1 patient group

Active therapy
Experimental group
Description:
All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
Treatment:
Device: Hand & Wrist Assisting Robotic Device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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