NCT01725659

Brief Summary

PURPOSE. After stroke many patients are unable to engage in normal upper limb functional activities, which may restrict them from participation in meaningful life roles. For many, conventional rehabilitation does not restore upper limb function to a useful level. The purpose of this research is to investigate the benefits of three promising motor learning interventions: focused intensive, motor learning (FIML); 2) robotics and motor learning (ROB-ML); and 3) functional neuromuscular stimulation and motor learning (FNS-ML).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2001

Longer than P75 for not_applicable

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

September 1, 2001

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

Enrollment Period

8.3 years

First QC Date

November 9, 2012

Last Update Submit

November 9, 2012

Conditions

Keywords

Strokeelectric stimulationroboticsmotor learning

Outcome Measures

Primary Outcomes (1)

  • Fugl Meyer

    impairment measure of coordination of the upper limb

    after 12 weeks of intervention

Study Arms (3)

Motor Learning

EXPERIMENTAL

subjects are provided with intensive motor learning training of the upper limb

Other: Motor Learning

Robotics and Motor Learning

EXPERIMENTAL

subject are provided with intensive motor learning and robotics training of the upper limb

Other: Motor LearningOther: Robotics

Motor learning and FES

EXPERIMENTAL

subjects are provided with intensive motor learning and surface FES (Functional Electrical Stimulation) of the upper limb

Other: Motor LearningOther: surface FES

Interventions

training of the hemiplegic upper limb with motor learning

Motor LearningMotor learning and FESRobotics and Motor Learning

subjects perform training of hemiplegic arm using an upper extremity robot

Robotics and Motor Learning

subjects are provided with surface FES to the hemiplegic upper limb

Motor learning and FES

Eligibility Criteria

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

You may qualify if:

  • \>1 year post stroke no acute, uncontrolled medical condition single stroke

You may not qualify if:

  • pacemaker other neurological condition more than one stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Stokes Cleveland Department of Veterans Affairs Medical Center

Cleveland, Ohio, 44118, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Robotics

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AutomationTechnologyTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2012

First Posted

November 14, 2012

Study Start

September 1, 2001

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 14, 2012

Record last verified: 2012-11

Locations