NCT02132650

Brief Summary

The VHA estimates that over 15,000 Veterans incur a stroke each year. As the population of older Veterans grows, stroke will become an increasingly important problem to the VHA. Recovery of walking function is the most common goal of stroke survivors. The proposed study will test whether training with accurate walking tasks to engage the damaged supraspinal motor pathways is more effective than training with steady state walking. The investigators expect that training accurate tasks will be more effective, thereby improving walking function of Veteran stroke survivors and reducing the burden of care placed on families and on the VHA. Furthermore, this rehabilitation approach can be accomplished at comparable cost to existing rehabilitation approaches, which is important given that the VHA invests $88 million per year toward outpatient care, including physical rehabilitation, in the first six months after stroke. This research also has implications for rehabilitation of other neurologically injured populations, including traumatic brain injury and incomplete spinal cord injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

2 active sites

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

April 23, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

June 2, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 9, 2020

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

5 years

First QC Date

April 23, 2014

Results QC Date

May 11, 2020

Last Update Submit

April 7, 2022

Conditions

Stroke

Keywords

RehabilitationWalkingMotor skills disordersElectromyography

Outcome Measures

Primary Outcomes (2)

  • Change in Walk Speed From Pre-Intervention (0 Months) to Post-Intervention (3 Months)

    self selected (preferred) steady state walking speed

    assessed pre-intervention (0 months) and post-intervention (3 months)

  • Change in Walk Speed From Pre-Intervention (0 Months) to Follow-Up (6 Months)

    self selected (preferred) steady state walking speed

    assessed pre-intervention (0 months) and follow-up (6 months)

Study Arms (2)

ACC

EXPERIMENTAL

Rehabilitation of walking using accurate (ACC) walking tasks

Behavioral: ACC training

SS

ACTIVE COMPARATOR

Rehabilitation of walking using typical steady state (SS) walking

Behavioral: SS training

Interventions

ACC trainingBEHAVIORAL

Rehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc.

ACC
SS trainingBEHAVIORAL

Rehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour.

SS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • occurrence of a single unilateral stroke within the previous 6-18 months (verified by MRI or CT from medical record)
  • living in the community and able to travel to training and assessment sites
  • approval of participation by primary care physician
  • age 18 - 80 years
  • lower extremity paresis indicated by Fugl-Meyer Assessment Score \< 30
  • deficit in at least one "synergy" subcategory (II - IV) of the Fugl-Meyer Assessment
  • self-selected 10m gait speed of 0.4 - 0.8 m/s (with or without an ankle/foot orthosis or cane)
  • able to provide informed consent
  • willingness to be randomized to either intervention group
  • written approval by primary care physician

You may not qualify if:

  • neurological disorder or injury (other than stroke) such as Parkinson' s disease or spinal cord injury
  • severe arthritis, such as awaiting joint replacement, that would interfere with study participation
  • cardiovascular disease (congestive heart failure, significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator, uncontrolled angina)
  • myocardial infarction or major heart surgery in the previous year
  • cancer requiring treatment in the past three years, except for nonmelanoma skin cancers and other cancers having an excellent prognosis (e.g., early stage breast or prostate cancer)
  • lung disease requiring use of corticosteroids or supplemental oxygen
  • renal disease requiring dialysis
  • current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
  • Mini-Mental State Examination (MMSE) score \<23
  • major depression (Patient Health Questionnaire score \> 10)
  • severe obesity (body mass index \> 35)
  • uncontrolled hypertension (systolic \> 200 mmHg and/or diastolic \> 110 mmHg)
  • uncontrolled diabetes with recent diabetic coma or frequent hypoglycemia
  • bone fracture or joint replacement in the previous six months
  • diagnosis of a terminal illness
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

Brooks Rehabilitation Hospital

Jacksonville, Florida, 32216, United States

Location

Related Publications (2)

  • Clark DJ, Rose DK, Butera KA, Hoisington B, DeMark L, Chatterjee SA, Hawkins KA, Otzel DM, Skinner JW, Christou EA, Wu SS, Fox EJ. Rehabilitation with accurate adaptability walking tasks or steady state walking: A randomized clinical trial in adults post-stroke. Clin Rehabil. 2021 Aug;35(8):1196-1206. doi: 10.1177/02692155211001682. Epub 2021 Mar 16.

    PMID: 33722075RESULT

  • Chatterjee SA, Daly JJ, Porges EC, Fox EJ, Rose DK, McGuirk TE, Otzel DM, Butera KA, Clark DJ. Mobility Function and Recovery After Stroke: Preliminary Insights From Sympathetic Nervous System Activity. J Neurol Phys Ther. 2018 Oct;42(4):224-232. doi: 10.1097/NPT.0000000000000238.

    PMID: 30138228DERIVED

MeSH Terms

Conditions

StrokeMotor Skills Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Dr. David Clark
Organization
Malcom Randall VA Medical Center
davidclark@ufl.edu
352-376-1611

Study Officials

  • David J. Clark, DSc

    North Florida/South Georgia Veterans Health System, Gainesville, FL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2014

First Posted

May 7, 2014

Study Start

June 2, 2014

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

May 5, 2022

Results First Posted

June 9, 2020

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)