Promoting Recovery Optimization With WALKing Exercise After Stroke

NCT02835313 | Completed Results DMC

• 1 other identifier: NIH 1R01HD086362-01A1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• Steps Per Day

  average change in steps per day between two time points, measured over at least a 3-day period for each time point

  Change from Baseline to 3 months (Post)

• Steps Per Day

  average change in steps per day between two time points, measured over at least a 3-day period for each time point

  Change from 3 months (Post) to 6 months

• Steps Per Day

  average change in steps per day between two time points, measured over at least a 3-day period for each time point

  Change from 3 months (Post) to 12 months

Secondary Outcomes (9)

• Six-minute Walk Test Distance

  Change from Baseline to 3 months (Post)

• Six-minute Walk Test Distance

  Change from 3 months (Post) to 6 months

• Six-minute Walk Test Distance

  Change from 3 months (Post) to 12 months

• Self-selected Gait Speed

  Change from Baseline to 3 months (Post)

• Self-selected Gait Speed

  Change from 3 months (Post) to 6 months

Study Arms (3)

FAST+SAM

EXPERIMENTAL

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

Behavioral: FAST+SAM

FAST alone

ACTIVE COMPARATOR

Subjects participate in fast walking training

Behavioral: FAST alone

SAM alone

ACTIVE COMPARATOR

Subjects participate in a step activity monitoring program

Behavioral: SAM alone

Interventions

FAST alone BEHAVIORAL

Subjects participate in fast walking training 3x/week for 12 weeks.

FAST alone

FAST+SAM BEHAVIORAL

Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks

FAST+SAM

SAM alone BEHAVIORAL

Subjects participate in a step activity monitoring program 3x/week for 12 weeks

SAM alone

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Delaware: lead
• University of Pennsylvania: collaborator
• Christiana Care Health Services: collaborator
• Indiana University: collaborator

Study Sites (1)

University of Delaware

Newark, Delaware, 19712, United States

Location

Related Publications (6)

• Thompson ED, McCartney KM, Pohlig RT, Hornby TG, Kasner SE, Raser-Schramm J, Henderson CE, Wright H, Wright T, Reisman DS. Maintenance of Improvements in Walking Activity in Individuals with Chronic Stroke: Follow-Up From the PROWALKS Randomized Controlled Trial. Neurorehabil Neural Repair. 2025 Oct;39(10):779-788. doi: 10.1177/15459683251352493. Epub 2025 Jul 10.

  PMID: 40637166 DERIVED

• McCartney KM, Pohlig RT, Miller A, Thompson ED, Reisman D. Matching Clinical Profiles with Interventions to Optimize Daily Stepping in People with Stroke. medRxiv [Preprint]. 2024 Nov 15:2024.11.14.24317334. doi: 10.1101/2024.11.14.24317334.

  PMID: 39606374 DERIVED

• Thompson ED, Pohlig RT, McCartney KM, Hornby TG, Kasner SE, Raser-Schramm J, Miller AE, Henderson CE, Wright H, Wright T, Reisman DS. Increasing Activity After Stroke: A Randomized Controlled Trial of High-Intensity Walking and Step Activity Intervention. Stroke. 2024 Jan;55(1):5-13. doi: 10.1161/STROKEAHA.123.044596. Epub 2023 Dec 22.

  PMID: 38134254 DERIVED

• Thompson ED, Pohlig RT, McCartney KM, Hornby TG, Kasner SE, Raser-Schramm J, Miller AE, Henderson CE, Wright H, Wright T, Reisman DS. Increasing activity after stroke: a randomized controlled trial of highintensity walking and step activity intervention. medRxiv [Preprint]. 2023 Aug 9:2023.03.11.23287111. doi: 10.1101/2023.03.11.23287111.

  PMID: 37609269 DERIVED

• 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.

  PMID: 33345115 DERIVED

• 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.

  PMID: 29649992 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Dr. Darcy Reisman, PT, PhD, FAPTA
• Organization: University of Delaware

dreisman@udel.edu

302-831-0508

Study Officials

• Darcy Reisman, PT, PhD

  University of Delaware

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 18, 2016
• Study Start: July 18, 2016
• Primary Completion: January 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 28, 2024
• Results First Posted: October 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)