NCT00847704

Brief Summary

This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_1 stroke

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
terminated

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, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

January 23, 2017

Completed
Last Updated

January 23, 2017

Status Verified

November 1, 2016

Enrollment Period

1.6 years

First QC Date

February 18, 2009

Results QC Date

December 17, 2014

Last Update Submit

November 23, 2016

Conditions

StrokeCerebrovascular Accident

Keywords

StrokeRehabilitationRobotics

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment of the Lower Extremity

    Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score.

    Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up

Secondary Outcomes (5)

  • Timed 10-Meter Walk

    Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up

  • Stroke Impact Scale

    Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up

  • Spasticity (Modified Ashworth) Scale

    Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up

  • Strength Test

    First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)

  • Active Motion Test

    First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)

Study Arms (1)

Test treatment group

EXPERIMENTAL

Device: Assisted movement and enhanced sensation

Device: Assisted movement and enhanced sensation

Interventions

Assisted movement and enhanced sensationDEVICE

Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.

Test treatment group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 12 months post-stroke
  • Cognitively and behaviorally capable of complying with the regimen
  • Functioning proprioception
  • Less than 50% of normal strength in the affected ankle, but able to stand with or without assistive devices

You may not qualify if:

  • Fractures of treated limb resulting in loss of range of motion
  • Spinal cord injury
  • Deep vein thrombosis
  • Peripheral nerve injury or neuropathy in the limb affected with motor disability
  • Osteoarthritis limiting range of motion
  • Skin condition not tolerant of device
  • Progressive neurodegenerative disorder
  • Uncontrolled seizure disorder
  • Botox treatment within the last 5 months
  • Baclofen pump

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • Cordo P, Lutsep H, Cordo L, Wright WG, Cacciatore T, Skoss R. Assisted movement with enhanced sensation (AMES): coupling motor and sensory to remediate motor deficits in chronic stroke patients. Neurorehabil Neural Repair. 2009 Jan;23(1):67-77. doi: 10.1177/1545968308317437. Epub 2008 Jul 21.

    PMID: 18645190BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Limitations and Caveats

Early termination due to lack of funding lead to only 2 subjects treated and analyzed.

Results Point of Contact

Title
Paul J. Cordo
Organization
Oregon Health & Science University
cordop@ohsu.edu
503-418-2520

Study Officials

  • Paul J. Cordo, PhD

    AMES Technology Inc./Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

April 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

January 23, 2017

Results First Posted

January 23, 2017

Record last verified: 2016-11

Locations

US(1)