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Promoting Recovery Optimization With WALKing Exercise After Stroke (PROWALKS)

Primary Purpose

Stroke

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FAST
FAST+SAM
SAM
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 21-85
  2. Chronic stroke (>6 months post stroke)
  3. Able to walk at self-selected speed without assistance from another person (assistive devices are allowed)
  4. Self-selected walking speed >0.3 m/s and <1.0 m/s
  5. Average steps/day <8,000
  6. Resting heart rate between 40-100 beats per minute
  7. Resting blood pressure between 90/60 to 170/90.

Exclusion Criteria:

  1. Evidence of cerebellar stroke
  2. Other potentially disabling neurologic conditions in addition to stroke
  3. Lower limb Botulinum toxin injection <4 months earlier
  4. Current participation in physical therapy
  5. Inability to walk outside the home prior to the stroke
  6. Coronary artery bypass graft, stent placement or myocardial infarction within past 3 months
  7. Musculoskeletal pain that limits activity
  8. Inability to communicate with investigators
  9. score >1 on question 1b and >0 on question 1c on the NIH Stroke Scale.

Sites / Locations

  • University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

FAST+SAM

FAST

SAM

Arm Description

Subjects participate in fast walking training in combination with a step activity monitoring program

Subjects participate in fast walking training

Subjects participate in a step activity monitoring program

Outcomes

Primary Outcome Measures

Steps per day

Secondary Outcome Measures

walking speed as measured by the 10 meter walk test
endurance as measured by the 6 minute walk test
oxygen consumption

Full Information

First Posted
July 11, 2016
Last Updated
September 25, 2023
Sponsor
University of Delaware
Collaborators
University of Pennsylvania, Christiana Care Health Services, Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT02835313
Brief Title
Promoting Recovery Optimization With WALKing Exercise After Stroke
Acronym
PROWALKS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 18, 2016 (undefined)
Primary Completion Date
January 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Delaware
Collaborators
University of Pennsylvania, Christiana Care Health Services, Indiana University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Stroke survivors, as a group, are extremely inactive and this has serious consequences for them, including an increased risk of a second stroke and developing other diseases. This study investigates a novel intervention designed to improve everyday activity after stroke by combining walking training to improve walking capacity with a program to encourage more daily walking.
Detailed Description
As a group, stroke survivors are more physically inactive than even the most sedentary older adults. Lack of physical activity has serious consequences in persons with stroke, including an increased risk of recurrent stroke, developing other diseases and mortality. Current rehabilitation interventions do little to improve real-world walking activity after stroke, suggesting that simply improving walking capacity is not sufficient for improving daily physical activity after stroke. Rather, the investigator's hypothesize that the combination of a fast walking intervention that improves walking capacity, with a step activity monitoring program that facilitates translation of gains from the clinic to the "real-world", would generate greater improvements in real world walking activity than with either intervention alone. Data from the investigator's lab provides support for this hypothesis; however, it suggests that the greater efficacy of combining the 2 interventions depends on a participant's initial walking activity. Thus, the investigator's do not expect that one intervention will be superior to the others for all participants, but rather that the combined intervention will be superior for those with low levels of baseline walking activity, speed and endurance. The specific objective of this study is to test whether and for whom combining fast walking training with a step activity monitoring program (FAST+SAM) is superior in improving real-world walking activity compared to fast walking training alone (FAST) or a step activity monitoring and feedback program alone (SAM) in those with chronic stroke. Using a randomized controlled experimental design, 225 chronic (> 6 months) stroke survivors, will complete 12 weeks of fast walking training (FAST), a step activity monitoring program (SAM) or a fast walking training + step activity monitoring program (FAST+SAM). Moderation of specific intervention outcomes by baseline characteristics will be evaluated to determine for whom the interventions are effective.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FAST+SAM
Arm Type
Experimental
Arm Description
Subjects participate in fast walking training in combination with a step activity monitoring program
Arm Title
FAST
Arm Type
Active Comparator
Arm Description
Subjects participate in fast walking training
Arm Title
SAM
Arm Type
Active Comparator
Arm Description
Subjects participate in a step activity monitoring program
Intervention Type
Behavioral
Intervention Name(s)
FAST
Intervention Description
Subjects participate in fast walking training 3x/week for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
FAST+SAM
Intervention Description
Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
SAM
Intervention Description
Subjects participate in a step activity monitoring program 3x/week for 12 weeks
Primary Outcome Measure Information:
Title
Steps per day
Time Frame
Change in steps per day from pre-intervention to 12 months later
Secondary Outcome Measure Information:
Title
walking speed as measured by the 10 meter walk test
Time Frame
Change in walking speed from pre-intervention to 12 months later
Title
endurance as measured by the 6 minute walk test
Time Frame
Change in endurance from pre-intervention to 12 months later
Title
oxygen consumption
Time Frame
Change in oxygen consumption from pre-intervention to 12 months later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 21-85 Chronic stroke (>6 months post stroke) Able to walk at self-selected speed without assistance from another person (assistive devices are allowed) Self-selected walking speed >0.3 m/s and <1.0 m/s Average steps/day <8,000 Resting heart rate between 40-100 beats per minute Resting blood pressure between 90/60 to 170/90. Exclusion Criteria: Evidence of cerebellar stroke Other potentially disabling neurologic conditions in addition to stroke Lower limb Botulinum toxin injection <4 months earlier Current participation in physical therapy Inability to walk outside the home prior to the stroke Coronary artery bypass graft, stent placement or myocardial infarction within past 3 months Musculoskeletal pain that limits activity Inability to communicate with investigators score >1 on question 1b and >0 on question 1c on the NIH Stroke Scale.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darcy Reisman, PT, PhD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be deposited in the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) repository.
Citations:
PubMed Identifier
33345115
Citation
Andreasen SC, Wright TR, Crenshaw JR, Reisman DS, Knarr BA. Relationships of Linear and Non-linear Measurements of Post-stroke Walking Activity and Their Relationship to Weather. Front Sports Act Living. 2020 Nov 3;2:551542. doi: 10.3389/fspor.2020.551542. eCollection 2020.
Results Reference
derived
PubMed Identifier
29649992
Citation
Wright H, Wright T, Pohlig RT, Kasner SE, Raser-Schramm J, Reisman D. Protocol for promoting recovery optimization of walking activity in stroke (PROWALKS): a randomized controlled trial. BMC Neurol. 2018 Apr 12;18(1):39. doi: 10.1186/s12883-018-1044-1.
Results Reference
derived

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Promoting Recovery Optimization With WALKing Exercise After Stroke

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