NCT00343304

Brief Summary

We will test whether robot driven, goal directed, trajectory corrected exercise enhances motor outcome in the upper limb of stroke patients better than matched motor activity on an upper body ergometer (monark).

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 not_applicable stroke

Timeline
Completed

Started Apr 2005

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

April 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2006

Completed
Last Updated

June 22, 2006

Status Verified

April 1, 2005

First QC Date

June 20, 2006

Last Update Submit

June 20, 2006

Conditions

Stroke

Keywords

Stroke.Robot.Ergometer.Group OT

Outcome Measures

Primary Outcomes (1)

  • Functional Independence Measure (FIM™)

Secondary Outcomes (5)

  • The Fugl-Meyer Assessment (FMA) scale

  • Motor Status Scale (MSS)

  • Medical Research Council (MRC)

  • Motor Power Scale (MPS) Action Research Arm Test (ARAT)

  • Modified Ashworth scale (MAS)

Interventions

RobotDEVICE
ErgometerDEVICE

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a recent acute stroke in the last 4 weeks
  • Patients with an upper extremity plegia (Medical Research Council \[MRC\] grade 2 or less at the shoulder joint),
  • Patients or their next of kin (in the absence of their being able to) provide with a written informed consent.
  • Aphasic alert patients provided they could follow simple directions given by verbal or gestural cues.

You may not qualify if:

  • Patients with anterior or severe inferior shoulder subluxation (3 cms) of the plegic arm
  • Patients without shoulder pain on passive range of 75 degrees forward flexion and 75 degrees abduction of the plegic arm
  • Patients with trophic skin changes and significant edema (shoulder-hand syndrome)
  • Patients with prior rotator cuff surgery, patients with bursitis and/or biceps tendonitis
  • Patients who have suffered recent cardiac events (myocardial infarction, congestive cardiac failure, recent coronary artery bypass surgery)
  • Patients who refuse to sign a written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Meheroz H Rabadi, MD, MRCPI

    Burke Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 20, 2006

First Posted

June 22, 2006

Study Start

April 1, 2005

Study Completion

May 1, 2006

Last Updated

June 22, 2006

Record last verified: 2005-04

Locations

US(1)