StrokePROWALKSNCT02835313

Promoting Recovery Optimization With WALKing Exercise After Stroke

A study testing FAST alone, FAST+SAM and SAM alone in people with Stroke, run by University of Delaware at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 21 to 85 years
Conditions the study is for: Stroke
What is being tested?: FAST alone, FAST+SAM and SAM alone
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 250 participants
Where: 1 siteUnited States
Study dates: 18 Jul 2016to Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Delaware
Newark, Delaware, 19712

Other trials in United States

About this study

Read the 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.

Conditions: Stroke
Being tested: FAST alone, FAST+SAM, SAM alone
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FAST aloneBehavioural
Subjects participate in fast walking training 3x/week for 12 weeks.
FAST+SAMBehavioural
Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks
SAM aloneBehavioural
Subjects participate in a step activity monitoring program 3x/week for 12 weeks

Study groups in NCT02835313
Study group	Role	What they receive
FAST+SAM	Experimental	Subjects participate in fast walking training in combination with a step activity monitoring program Receives: Behavioral: FAST+SAM
FAST alone	Active comparator	Subjects participate in fast walking training Receives: Behavioral: FAST alone
SAM alone	Active comparator	Subjects participate in a step activity monitoring program Receives: Behavioral: SAM alone

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: Change from 3 months (Post) to 12 months

Secondary outcomes (9)

Six-minute Walk Test Distance
change between two time points in endurance (measured by distance attained on the 6 minute walk test)
Measured: Change from Baseline to 3 months (Post)
Six-minute Walk Test Distance
change between two time points in endurance (measured by distance attained on the 6 minute walk test)
Measured: Change from 3 months (Post) to 6 months
Six-minute Walk Test Distance
change between two time points in endurance (measured by distance attained on the 6 minute walk test)
Measured: Change from 3 months (Post) to 12 months
Self-selected Gait Speed
change between two time points in average self-selected speed on the 10m walk test
Measured: Change from Baseline to 3 months (Post)
Self-selected Gait Speed
change between two time points in average self-selected speed on the 10m walk test
Measured: Change from 3 months (Post) to 6 months
Self-selected Gait Speed
change between two time points in average self-selected speed on the 10m walk test
Measured: Change from 3 months (Post) to 12 months
Oxygen Consumption
change between two time points in average oxygen consumption at ventilatory threshold
Measured: Change from Baseline to 3 months (Post)
Oxygen Consumption
change between two time points in average oxygen consumption at ventilatory threshold
Measured: Change from 3 months (Post) to 6 months
Oxygen Consumption
change between two time points in average oxygen consumption at ventilatory threshold
Measured: Change from 3 months (Post) to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jul 2016Dec 2023

First posted18 Jul 2016 (estimated)
Study start18 Jul 2016
Primary completionJan 2023
Study completionDec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02835313
Sponsor's protocol ID: NIH 1R01HD086362-01A1
Acronym: PROWALKS
Status last verified: Mar 2024
First submitted: 11 Jul 2016
Last updated: 28 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified data will be deposited in the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) repository.

Publications

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.
PubMed 40637166
McCartney KM, Pohlig RT, Tulimieri DT, Boyne P, Morton SM, Reisman DS. Impact of Individual Factors on Exercise Dose During a Walking Intervention in People With Stroke. J Neurol Phys Ther. 2025 Jul 1;49(3):153-161. doi: 10.1097/NPT.0000000000000517. Epub 2025 May 5.
PubMed 40323627
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.
PubMed 39606374
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.
PubMed 38134254
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.
PubMed 37609269
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.
PubMed 33345115
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.
PubMed 29649992

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Promoting Recovery Optimization With WALKing Exercise After Stroke
ClinicalTrials.gov ID: NCT02835313
Acronym / sponsor ID: PROWALKS / NIH 1R01HD086362-01A1
Conditions: Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: University of DelawareUniversity, hospital or other
Collaborators: University of Pennsylvania, Christiana Care Health Services, Indiana University
Study start: 18 Jul 2016
Primary completion: Jan 2023 (actual)
Study completion: Dec 2023 (actual)
First posted: 18 Jul 2016 (estimated)
Results: Posted 28 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
FAST+SAM	Experimental	Behavioral: FAST+SAMSubjects participate in fast walking training in combination with a step activity monitoring program
FAST alone	Active comparator	Behavioral: FAST aloneSubjects participate in fast walking training
SAM alone	Active comparator	Behavioral: SAM aloneSubjects participate in a step activity monitoring program

Who may qualify

Ages: 21 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FAST aloneSubjects participate in fast walking training 3x/week for 12 weeks.	Behavioural	FAST alone
FAST+SAMSubjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	Behavioural	FAST+SAM
SAM aloneSubjects participate in a step activity monitoring program 3x/week for 12 weeks	Behavioural	SAM alone

Primary outcome

Steps Per Day
Time frame: Change from Baseline to 3 months (Post)
average change in steps per day between two time points, measured over at least a 3-day period for each time point
Steps Per Day
Time frame: Change from 3 months (Post) to 6 months
average change in steps per day between two time points, measured over at least a 3-day period for each time point
Steps Per Day
Time frame: Change from 3 months (Post) to 12 months
average change in steps per day between two time points, measured over at least a 3-day period for each time point

9 secondary outcomes

Six-minute Walk Test Distance
Time frame: Change from Baseline to 3 months (Post)
Six-minute Walk Test Distance
Time frame: Change from 3 months (Post) to 6 months
Six-minute Walk Test Distance
Time frame: Change from 3 months (Post) to 12 months
Self-selected Gait Speed
Time frame: Change from Baseline to 3 months (Post)
Self-selected Gait Speed
Time frame: Change from 3 months (Post) to 6 months
Self-selected Gait Speed
Time frame: Change from 3 months (Post) to 12 months
Oxygen Consumption
Time frame: Change from Baseline to 3 months (Post)
Oxygen Consumption
Time frame: Change from 3 months (Post) to 6 months
Oxygen Consumption
Time frame: Change from 3 months (Post) to 12 months

Results and safety

Results posted to the registry on 28 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FAST+SAM	80	48
FAST Alone	89	64
SAM Alone	81	49

Primary outcome: Steps Per Day

Time frame: Change from Baseline to 3 months (Post). Mean (95% Confidence Interval). Unit: steps per day

Measure	FAST+SAM n = 80	FAST Alone n = 89	SAM Alone n = 81
Value	1307 (752 to 1861)	406 (-63 to 876)	1542 (1014 to 2069)

Primary outcome: Steps Per Day

Time frame: Change from 3 months (Post) to 6 months. Mean (95% Confidence Interval). Unit: steps per day

Measure	FAST+SAM n = 63	FAST Alone n = 69	SAM Alone n = 68
Value	-400 (-990 to 190)	-160 (-697 to 376)	-1016 (-1546 to -485)

Primary outcome: Steps Per Day

Time frame: Change from 3 months (Post) to 12 months. Mean (95% Confidence Interval). Unit: steps per day

Measure	FAST+SAM n = 63	FAST Alone n = 69	SAM Alone n = 68
Value	-568 (-1185 to 48)	-610 (-1162 to -59)	-1072 (-1675 to -469)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FAST+SAM	14 of 80 (17.5%)	25 of 80 (31.3%)	0 of 80
FAST Alone	9 of 89 (10.1%)	38 of 89 (42.7%)	1 of 89
SAM Alone	3 of 81 (3.7%)	19 of 81 (23.5%)	0 of 81

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40637166Thompson 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.
Derived from this study: PubMed 40323627McCartney KM, Pohlig RT, Tulimieri DT, Boyne P, Morton SM, Reisman DS. Impact of Individual Factors on Exercise Dose During a Walking Intervention in People With Stroke. J Neurol Phys Ther. 2025 Jul 1;49(3):153-161. doi: 10.1097/NPT.0000000000000517. Epub 2025 May 5.
Derived from this study: PubMed 39606374McCartney 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.
Derived from this study: PubMed 38134254Thompson 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.
Derived from this study: PubMed 37609269Thompson 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.
Derived from this study: PubMed 33345115Andreasen 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.
Derived from this study: PubMed 29649992Wright 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.
Individual participant dataSharing planned: Yes. De-identified data will be deposited in the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) repository.

Related trials for Stroke

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Darcy Reisman, PT, PhD principal investigator

University of Delaware

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FAST alone, FAST+SAM and SAM alone in people with Stroke, run by University of Delaware at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Steps Per Day (time frame: Change from Baseline to 3 months (Post)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02835313, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.