NCT00878085

Brief Summary

The investigators will study motor recovery after robot-assisted therapy after stroke. A small clinical trial will be conducted to quantify the central nervous system changes associated with robotic or standard training, and identify trends across high and low responders in terms of patterns of change in cortical activity and type of white matter connectivity.The investigators hypothesize that robot training will lead to larger improvements as compared to standard occupational therapy. The investigators hypothesize that high responders to the robot training will have reduced compensatory activation in the bilateral area and will connectivity in the motor tracts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

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

November 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2009

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

4.6 years

First QC Date

March 23, 2009

Last Update Submit

February 3, 2014

Conditions

HemiparesisIschemic StrokeChronic

Keywords

Robot TherapyUpper LimbStrokeRehabilitationfMRIDTI

Outcome Measures

Primary Outcomes (3)

  • Clinical Measures: Fugl-Meyer (Motor control), Functional Hand Evaluation (ADL), Jebsen Taylor

    Pre (2x) , Post, Follow-Up

  • Biomechanical:Movement Time, Grasp Aperture, Movement Smoothness

    Pre (2x), Post, Follow-up

  • Imaging Measures: BOLD response (activation), Laterality Index, Fractional Anisotropy, Fiber Density Index

    Pre (1x), Post, Follow-up

Secondary Outcomes (2)

  • Clinical Measures: Joint ROM, MMT, Spasticity

    Pre(2x), Post, Follow-up

  • Clinical Measures: Pain, Exertion

    During Therapy

Study Arms (2)

1

EXPERIMENTAL

Robot Therapy with activities of daily living (ADLs)

Device: Robot Therapy Device

2

ACTIVE COMPARATOR

Standard Occupational Therapy

Behavioral: Occupational Therapy

Interventions

Robot Therapy DeviceDEVICE

3x a week for 4 weeks

1
Occupational TherapyBEHAVIORAL

3x a week for 4 weeks

2

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke:
  • to 85 years
  • Right-handed (evaluated with handedness survey)
  • suffered a unilateral ischemic stroke in the motor control area, which resulted in hemiparesis of the arm (confirmed by medical data),
  • at least 6-months post-stroke
  • residual movement at least (a) 15 degree shoulder flexion or adduction, (b) 15 degree active elbow flexion and extension
  • not claustrophobic
  • not depressed (as measured depression survey)
  • able to use the scanner, i.e., passes the fMRI screening survey
  • able to understand the instructions and complete the tracking tasks Control
  • older than 20 years
  • Right-handed (evaluated with survey)
  • not claustrophobic
  • able to use the scanner, i.e., passes the fMRI screening survey
  • able to understand the instructions and complete the tracking tasks
  • +1 more criteria

You may not qualify if:

  • Stroke:
  • brain stem, stroke
  • pre-existing neurological or psychiatric disorders
  • Spasticity \>3 at elbow or fingers on Ashworth
  • demonstrated visuospatial, language or attention deficits of a severity that prevents understanding the task
  • shoulder pain or joint pain during movements
  • synkinetic movements or mirror movements
  • decline to participate
  • will not comply with full protocol
  • pregnant
  • allergic to goretex and conductivity gel
  • Control
  • decline to participate
  • will not comply with full protocol
  • pregnant
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Clement J Zablocki VA

Milwaukee, Wisconsin, 53295, United States

Location

MeSH Terms

Conditions

ParesisIschemic StrokeBronchiolitis Obliterans SyndromeStroke

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Michel Torbey, MD

    Medical College of Wisconsin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Associate Professor

Study Record Dates

First Submitted

March 23, 2009

First Posted

April 8, 2009

Study Start

November 1, 2008

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations

US(2)