NCT00037934

Brief Summary

We have established the feasibility and effectiveness of robot-aided rehabilitation in stroke patients using a robot for neurological rehabilitation designed and built by MIT. Results of a pilot study of 20 patients were promising and showed that robot therapy is safe, tolerated by patients and produces a significant, measurable benefit. We propose to test that the robotic upper extremity trainer is an acceptable cost effective adjunct to standard occupational therapy for patients with dysfunction of the shoulder and elbow due to hemiparetic stroke in a VA rehabilitation program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 stroke

Timeline
Completed

Started Apr 2002

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

October 7, 2011

Status Verified

October 1, 2011

Enrollment Period

2.4 years

First QC Date

May 24, 2002

Last Update Submit

October 6, 2011

Conditions

Stroke

Keywords

RobotStrokeUpper Extremity

Outcome Measures

Primary Outcomes (1)

  • Upper limb Motor Status Score, Wolf Motor Function Test, Motor Power Assessment, and Fugl-Meyer Upper Extremity Motor Performance Test

    The Primary Outcome measures were performed at baseline, after completion of 18 sessions of intervention and at 3 months follow-up.

Study Arms (2)

1

EXPERIMENTAL

Robot exercise group

Device: Upper extremity robot

2

ACTIVE COMPARATOR

Traditional exercise group

Device: Upper extremity robotOther: Traditional Supervised Upper Extremity Exercises

Interventions

Upper extremity robotDEVICE

Robotic upper extremity neuro-rehabilitation

12
Traditional Supervised Upper Extremity ExercisesOTHER

Arm ergometer, reaching, and stretching exercises

2

Eligibility Criteria

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

You may qualify if:

  • Chronic Stroke
  • Manual Muscle Score of Grade 3 or lower in at least one muscle of the affected arm

You may not qualify if:

  • Acute Stroke
  • Contracture or orthopedic problems limiting the movement of the affected arm
  • Visual deficit such that the participant cannot see the test pattern on the robot trainer
  • Serious complicating medical illness
  • Botox treatment to the involved arm within three 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

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Christopher Bever, MD

    VA Maryland Health Care System, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2002

First Posted

May 27, 2002

Study Start

April 1, 2002

Primary Completion

September 1, 2004

Study Completion

December 1, 2004

Last Updated

October 7, 2011

Record last verified: 2011-10

Locations

US(1)