NCT00125619

Brief Summary

The overriding goal of this proposal is to identify the critical physiological and biomechanical effects of BWSTT for promoting improved locomotor function in persons with post-stroke hemiparesis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable 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

First Submitted

Initial submission to the registry

July 28, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
4.3 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
7.2 years until next milestone

Results Posted

Study results publicly available

February 17, 2017

Completed
Last Updated

February 17, 2017

Status Verified

December 1, 2016

Enrollment Period

4.3 years

First QC Date

July 28, 2005

Results QC Date

April 17, 2015

Last Update Submit

December 23, 2016

Conditions

Stroke

Keywords

biomechanicsstrokeelectromyographyGait disability strokelocomotor therapymuscular weaknessreflex variability stroke

Outcome Measures

Primary Outcomes (1)

  • Self-selected Overground Walking Speed

    Overground walking speed determined as rate of walking over a 10 meter distance.

    4 weeks (s/p 12 sessions of locomotor training)

Secondary Outcomes (6)

  • Fast Walking Speed

    4 weeks (s/p 12 training sessions)

  • Six Minute Walk

    4 weeks

  • Step Length Ratio (Abs)

    4 weeks

  • Lower Extremity Fugl-Meyer Motor Assessment

    4 weeks

  • Short Physical Performance Battery

    4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Arm 1: Therapist assisted

ACTIVE COMPARATOR

Therapist assisted locomotor training (partial body-weight supported)

Behavioral: Locomotor training

Arm 2: Robot-assisted

EXPERIMENTAL

Robot-assisted locomotor training (partial body-weight supported)

Behavioral: Locomotor training

Interventions

Locomotor trainingBEHAVIORAL

This study compares two forms of Iocomotor training: 1) standard or manual - in which an individual is provided partial body weight support while walking on a treadmill with assistance of 1-3 therapists to move the legs and stabilize the trunk/pelvis and 2) robotic-guided - in which an exoskeleton robot (Lokomat) guides movement of the walking pattern. Partial body-weight support, treadmill walking and treadmill speed are consistent between the study arms.

Also known as: partial body-weight supported treadmill training, body-weight supported treadmill training
Arm 1: Therapist assistedArm 2: Robot-assisted

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of cerebrovascular accident
  • Single event
  • Unilateral hemiplegia
  • Locomotor disability
  • Ability to walk independently 25' on level ground (may use an assistive device \[cane or walker\]; may NOT use a brace)
  • Cognitive ability to follow 3-step commands

You may not qualify if:

  • Unstable or uncontrolled blood pressure
  • Uncontrolled seizures
  • Severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

Related Publications (2)

  • Westlake KP, Patten C. Pilot study of Lokomat versus manual-assisted treadmill training for locomotor recovery post-stroke. J Neuroeng Rehabil. 2009 Jun 12;6:18. doi: 10.1186/1743-0003-6-18.

    PMID: 19523207RESULT

  • Spiess MR, Jaramillo JP, Behrman AL, Teraoka JK, Patten C. Unexpected recovery after robotic locomotor training at physiologic stepping speed: a single-case design. Arch Phys Med Rehabil. 2012 Aug;93(8):1476-84. doi: 10.1016/j.apmr.2012.02.030. Epub 2012 Mar 23.

    PMID: 22446153RESULT

MeSH Terms

Conditions

StrokeMuscle Weakness

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Limitations and Caveats

Small sample size, but consistent with intent of pilot study Inclusion criterion was \>6 months post-event, allowing for large heterogeneity in chronicity Intervention was limited (12 sessions distributed over 4 weeks)

Results Point of Contact

Title
Dr. Carolynn Patten
Organization
VA Brain Rehabilitation Research Center
patten@phhp.ufl.edu
352.376.1611

Study Officials

  • Carolynn Patten, PhD

    North Florida/South Georgia Veterans Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2005

First Posted

August 1, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 17, 2017

Results First Posted

February 17, 2017

Record last verified: 2016-12

Locations

US(1)