NCT01288040

Brief Summary

The purpose of this study is to determine whether split belt training can be used to treat walking pattern deficits from stroke and to determine whether different schedules and types of long term training on a custom split belt treadmill are likely to change/improve walking symmetry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P75+ for phase_1 stroke

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_1 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

4 years

First QC Date

January 25, 2011

Last Update Submit

March 31, 2015

Conditions

StrokeHemiparesis

Keywords

stroketreadmillwalkinghemiparesistraining

Outcome Measures

Primary Outcomes (1)

  • Whether different schedules and types of long term training on a custom split belt treadmill are likely to change/improve walking symmetry

    To determine which schedule is showing more improvement different walking parameters will be investigated such as change in step length. Subjects will have markers placed at different joints on their body to allow our cameras to watch how their walking pattern changes during the duration of the study, to see if any improvements develop.

    Participants will be assessed at the beginning and end of either a 2 week or 4 week training schedule. All participants will be tested 1 month following the end of training.

Study Arms (1)

Treadmill exercise

EXPERIMENTAL

Split-belt treadmill training

Behavioral: Split Belt treadmill

Interventions

Split Belt treadmillBEHAVIORAL

A split belt treadmill is like a typical treadmill that is seen in the gym, except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds can be set to get at the same speed, making this treadmill similar to any regular treadmill, but, belt speeds can also be set so that one belt moves a little faster than the other. The belts are never set at a running or jogging speed, only a self-paced walking speed regardless of whether the belts are both going the same speed or both going slightly different speeds.

Also known as: Woodway Split Belt Treadmill, Company: Woodway USA, Inc
Treadmill exercise

Eligibility Criteria

Age2 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • stroke or hemiparesis
  • able to walk but has residual gait deficit (including those who walk with a cane or walker
  • This is their first and only stroke
  • Able to walk for 5 minutes at their self-paced speed
  • Children age 2-17; Adults age 18-80

You may not qualify if:

  • Cerebellar signs (e.g.ataxic hemiparesis)
  • Congestive heart failure
  • Peripheral artery disease with claudication
  • Pulmonary or renal failure
  • Unstable angina
  • Uncontrolled hypertension (\>190/110 mmHg)
  • Dementia
  • Severe aphasia
  • Orthopedic or pain conditions
  • Foster children
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Motion Analysis Lab in the Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Related Links

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amy J Bastian, PhD, PT

    Kennedy Krieger Institute and Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 25, 2011

First Posted

February 2, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

US(1)