NCT00011583

Brief Summary

Our long term objectives are to understand the mechanisms of motor impairment following neurologic injury and to develop interventions to improve motor recovery. A series of complementary, overlapping clinical trials and development activities will validate and optimize the use of robot-assisted upper limb therapy for neuro rehabilitation. We have developed a robotic system that assists or resists elbow and shoulder movements in three dimensional space. In addition to unilateral exercise modes, a novel bimanual mode enables hemiparetic subjects to practice mirror image upper limb exercises.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2000

Typical duration for phase_2

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

January 1, 2000

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2001

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2001

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
Last Updated

March 11, 2008

Status Verified

March 1, 2008

Enrollment Period

3.9 years

First QC Date

February 22, 2001

Last Update Submit

March 10, 2008

Conditions

Acute Stroke

Keywords

CerebrovascularHemiplegiaRobotics

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer score

    end of training, 6-month follow-up

Study Arms (2)

1

EXPERIMENTAL

1 hour/day of mechanically-assisted upper limb therapy

Device: Robot-assisted therapy

2

ACTIVE COMPARATOR

1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot

Device: Traditional therapy

Interventions

Robot-assisted therapyDEVICE

1 hour/day of mechanically-assisted upper limb therapy

1
Traditional therapyDEVICE

1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot

2

Eligibility Criteria

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

You may qualify if:

  • Stroke patients

You may not qualify if:

  • Unable to follow instructions; medically unstable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Texas Veterans Health Care System

Temple, Texas, 76504, United States

Location

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Charles Burgar, MD

    Central Texas Veterans Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

February 22, 2001

First Posted

February 26, 2001

Study Start

January 1, 2000

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

March 11, 2008

Record last verified: 2008-03

Locations

US(1)