NCT00011596

Brief Summary

To date, conventional rehabilitation is not able to restore normal, safe, gait for many individuals with stroke. We have identified nine gait component deficits which respond to the FNS-IM intervention. This study will test a refined treatment protocol of 3 months duration to restore volitional gait by restoring those nine gait components simultaneously. In addition, we will incorporate into the treatment protocol a promising non-invasive technique of partial body weight-supported (BWS) gait training on a treadmill. BWS and FNS-IM have the potential to provide additive effects for the patient and restore volitional gait more quickly and more completely than would otherwise be possible with one technique alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2 stroke

Timeline
Completed

Started Aug 2000

Typical duration for phase_2 stroke

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

August 1, 2000

Completed
7 months 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
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2001

First QC Date

February 22, 2001

Last Update Submit

January 20, 2009

Conditions

Stroke

Keywords

Hemiplegia, gait, electric stimulation

Interventions

Gait TrainingPROCEDURE

Eligibility Criteria

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

VAMC, Cleveland

Cleveland, Ohio, 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

  • John Fryer, Ph.D. Asst. Director

    Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development service

  • Nancy Rocheleau, Program Analyst

    Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development service

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

August 1, 2000

Study Completion

August 1, 2003

Last Updated

January 21, 2009

Record last verified: 2001-01

Locations

US(1)