NCT02507466

Brief Summary

The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jul 2015

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

Study Start

First participant enrolled

July 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

4.3 years

First QC Date

July 21, 2015

Last Update Submit

January 3, 2020

Conditions

Stroke

Keywords

locomotion

Outcome Measures

Primary Outcomes (1)

  • Change in peak walking speed

    fastest comfortable walking speed overground

    At baseline, following 8 weeks of training and a 2 month follow-up

Secondary Outcomes (2)

  • Change in Functional Gait Assessment

    At baseline, following 8 weeks of training and a 2 month follow-up

  • Change in 5X sit-to-stand transfer time

    At baseline, following 8 weeks of training and a 2 month follow-up

Study Arms (3)

Variable high-intensity Training

EXPERIMENTAL

high intensity variable stepping exercise on a treadmill and overground

Behavioral: exercise

Variable low-intensity training

ACTIVE COMPARATOR

low intensity variable stepping exercise on a treadmill and overground

Behavioral: exercise

Constant High Intensity Training

ACTIVE COMPARATOR

high intensity constant (forward) stepping exercise on a treadmill and overground

Behavioral: exercise

Interventions

exerciseBEHAVIORAL

Variable conditions of stepping practice

Constant High Intensity TrainingVariable high-intensity TrainingVariable low-intensity training

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • history unilateral stroke \> 6 months duration
  • walks without physical assistance at speeds \< 1.0 m/s

You may not qualify if:

  • no other cardiopulmonary, metabolic, neurological orthopedic injury that may contribute to walking outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

  • Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.

    PMID: 34695300DERIVED

  • Hornby TG, Henderson CE, Holleran CL, Lovell L, Roth EJ, Jang JH. Stepwise Regression and Latent Profile Analyses of Locomotor Outcomes Poststroke. Stroke. 2020 Oct;51(10):3074-3082. doi: 10.1161/STROKEAHA.120.031065. Epub 2020 Sep 4.

    PMID: 32883192DERIVED

  • Ardestani MM, Henderson CE, Mahtani G, Connolly M, Hornby TG. Locomotor Kinematics and Kinetics Following High-Intensity Stepping Training in Variable Contexts Poststroke. Neurorehabil Neural Repair. 2020 Jul;34(7):652-660. doi: 10.1177/1545968320929675. Epub 2020 Jun 6.

    PMID: 32507027DERIVED

  • Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.

    PMID: 31434543DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Thomas Hornby, PT, PhD

    RIC/NU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3 arm RCT - high intensity variable, high intensity forward, low intensity variable
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 24, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

January 6, 2020

Record last verified: 2020-01

Locations

US(1)