NCT00333983

Brief Summary

The purpose of this study is to compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

March 20, 2014

Completed
Last Updated

March 20, 2014

Status Verified

February 1, 2014

Enrollment Period

3.8 years

First QC Date

June 2, 2006

Results QC Date

August 30, 2013

Last Update Submit

February 3, 2014

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, \& Steglind, 1975; Gladstone, Danells, \& Black, 2002). Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome.

    Baseline to Final Training (6 weeks)

Study Arms (2)

Arm 1

EXPERIMENTAL

Robot Exercise Group

Device: Robotic Upper Extremity Neurorehabilitation

Arm 2

ACTIVE COMPARATOR

Traditional Upper Extremity Exercise Group

Other: Traditional Upper Extremity Exercise Group

Interventions

Robotic Upper Extremity NeurorehabilitationDEVICE

Upper extremity exercise using a planar robot Upper extremity exercise using a planar and vertical robot

Arm 1
Traditional Upper Extremity Exercise GroupOTHER

Upper extremity stretching, skateboard reaching activities, and arm ergometer

Arm 2

Eligibility Criteria

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

You may qualify if:

  • Stroke onset greater than six months before randomization for ischemic stroke patients and one year before randomization for hemorrhagic stroke patients
  • A grade 3 or lower in Manual Muscle Test in the hemiparetic elbow flexion and shoulder abduction

You may not qualify if:

  • Subjects unable to give informed consent
  • Serious complicating medical illness
  • Contracture or orthopedic problems limiting the range of joint movement in the study arm
  • Visual loss
  • Stroke occurred within 6 months for ischemic stroke patients, one year for hemorrhagic patients
  • Botox treatment within 3 months of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

  • Conroy SS, Whitall J, Dipietro L, Jones-Lush LM, Zhan M, Finley MA, Wittenberg GF, Krebs HI, Bever CT. Effect of gravity on robot-assisted motor training after chronic stroke: a randomized trial. Arch Phys Med Rehabil. 2011 Nov;92(11):1754-61. doi: 10.1016/j.apmr.2011.06.016. Epub 2011 Aug 17.

    PMID: 21849168RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Limitations and Caveats

This study was terminated early with the current number of subjects analyzed. A midstudy futility analysis showed a need for 99 participants per group to determine signifcance between the robotic training over the intensive conventional exercise.

Results Point of Contact

Title
Dr. Susan S. Conroy
Organization
VA Maryland Health Care System, Baltimore
susan.conroy@va.gov
(410) 605-7000

Study Officials

  • Christopher Bever, MD

    VA Maryland Health Care System, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

June 1, 2006

Primary Completion

April 1, 2010

Study Completion

February 1, 2011

Last Updated

March 20, 2014

Results First Posted

March 20, 2014

Record last verified: 2014-02

Locations

US(1)