CVA (Cerebrovascular Accident)NCT03561246

Incline Training to Personalize Motor Control Interventions After Stroke

A study testing Incline treadmill walking and Decline treadmill walking in people with CVA (Cerebrovascular Accident), run by VA Office of Research and Development at 2 sites 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

This study will evaluate the use of incline and decline treadmill training to address specific motor control deficits identified within different post-stroke walking patterns. Read more about this study

Who is it for?: Ages 25 to 75 yearsHealthy volunteers can take part
Conditions the study is for: CVA (Cerebrovascular Accident)
What is being tested?: Incline treadmill walking and Decline treadmill walking
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 2 sitesUnited States
Study dates: 1 Jul 2018to 30 Jun 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 25 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

stroke 6 months
residual paresis in the lower extremity (Fugl-Meyer LE motor score <34)
ability to walk without assistance at speeds ranging from 0.2 - 1.0 m/s (with a support harness for biomechanical testing)
Ability to walk on a treadmill without orthotic or assistive device using overhead harness system
provision of informed consent, and 8) written approval from the primary physician (see attached sample of Medical Approval Cover Letter).

Who cannot join

history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADLs
History of COPD or oxygen dependence
Pre-existing neurological disorders or dementia
History of major head trauma
Pp between 0.47 and 0.53
Legal blindness or severe visual impairment

Show all 9Show fewer

Severe arthritis or other problems that limit passive ROM
History of DVT or pulmonary embolism within 6 months
Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799
MUSC Center for Rehabilitation Research in Neurologic Conditions
Charleston, South Carolina, 29425

Other trials in United States

About this study

This study will evaluate the use of incline and decline treadmill training to address specific motor control deficits identified within different post-stroke walking patterns.

Read the detailed description

This study seeks to develop a theory-based clinical decision-making framework for the training of walking recovery after stroke based on how different biomechanical patterns of walking illustrate distinct motor control deficits. Each participant will complete 12 sessions (three times a week for four weeks) of either INCLINE, DECLINE, or CONTROL training. Clinical and biomechanical outcome measures will be collected pre- and post-training and after a one-month follow-up period. In addition, the investigators will collect a battery of clinical outcome measures before and after training. Spatiotemporal variables (including SSWS) will be collected before and after each session. All clinical and biomechanical assessments will be conducted by an evaluator blinded to training group allocation.

Conditions: CVA (Cerebrovascular Accident)
Being tested: Incline treadmill walking, Decline treadmill walking, Level Treadmill (Control)
Keywords: Stroke, Rehabilitation, Walking, Biomechanics
Medical subject headings: Stroke

What participants receive

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

Incline treadmill walkingOther
Those with a Pp <0.47 or >0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
Decline treadmill walkingOther
Those with a Pp <0.47 or >0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
Level Treadmill (Control)Other
Those with a Pp <0.47 or >0.53 will undergo LEVEL training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.

Study groups in NCT03561246
Study group	Role	What they receive
Personalized training effect on SSWS and Pp - Incline	Active comparator	Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Incline treadmill walking: Those with a Pp <0.47 or >0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. Receives: Other: Incline treadmill walking
Personalized training effect on SSWS and Pp - Decline	Active comparator	Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Decline treadmill walking: Those with a Pp <0.47 or >0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. Receives: Other: Decline treadmill walking
Personalized training effect on SSWS and Pp - Level treadmill (Control)	Active comparator	Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Level treadmill walking: Those with a Pp <0.47 or >0.53 will undergo LEVEL training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. Receives: Other: Level Treadmill (Control)

What is being measured

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

Change in Gait Speed
Participants will be asked to complete a 10 Meter Walk Test and a difference will be calculated between pre and post speed.
Measured: Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.

Secondary outcomes (1)

Change in Paretic Propulsion Symmetry
Quantitative measure of the coordinated output of the paretic leg and is defined as the percentage of propulsion performed by the paretic leg.
Measured: Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.

Timeline

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

1 Jul 201830 Jun 2023

First posted19 Jun 2018
Study start1 Jul 2018
Primary completion31 May 2022
Study completion30 Jun 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.
Other trials for CVA (Cerebrovascular Accident)Studies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
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: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03561246
Sponsor's protocol ID: N2665-R
Other IDs: 77797
Status last verified: May 2024
First submitted: 23 May 2018
Last updated: 22 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: As a clinical trial, the details of this project will be entered into ClinicalTrials.gov. Clinical data from assessment sessions will be recorded on hard copies (stored in a locked file cabinet in the Ralph H. Johnson VAMC rehabilitation research space) and entered into a RedCAP electronic database by the project coordinator immediately after each session. These data will be de-identified for further analysis. Only the PI will only have access to de-identified data. Gait data will be analyzed using a custom MATLAB program, automatically populating a LabView Data Viewer from which customized data may be retrieved. The research coordinator will check the data entry, and pool all data into a group-wide de-identified spreadsheet. All data from training sessions will also be analyzed and stored using an automated MATLAB program. All electronic data will be stored on a secure server that is backed-up nightly.

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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Study at a glance

From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Incline Training to Personalize Motor Control Interventions After Stroke
ClinicalTrials.gov ID: NCT03561246
Acronym / sponsor ID: N2665-R
Conditions: CVA (Cerebrovascular Accident)
Keywords: Stroke, Rehabilitation, Walking, Biomechanics
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Jul 2018 (actual)
Primary completion: 31 May 2022 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 19 Jun 2018 (actual)
Results: Posted 22 May 2024

Clinical summary

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

This study will evaluate the use of incline and decline treadmill training to address specific motor control deficits identified within different post-stroke walking patterns.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Personalized training effect on SSWS and Pp - Incline	Active comparator	Other: Incline treadmill walkingDetermine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Incline treadmill walking: Those with a Pp <0.47 or >0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
Personalized training effect on SSWS and Pp - Decline	Active comparator	Other: Decline treadmill walkingDetermine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Decline treadmill walking: Those with a Pp <0.47 or >0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
Personalized training effect on SSWS and Pp - Level treadmill (Control)	Active comparator	Other: Level Treadmill (Control)Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Level treadmill walking: Those with a Pp <0.47 or >0.53 will undergo LEVEL training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.

Who may qualify

Ages: 25 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

stroke 6 months
residual paresis in the lower extremity (Fugl-Meyer LE motor score <34)
ability to walk without assistance at speeds ranging from 0.2 - 1.0 m/s (with a support harness for biomechanical testing)
Ability to walk on a treadmill without orthotic or assistive device using overhead harness system
provision of informed consent, and 8) written approval from the primary physician (see attached sample of Medical Approval Cover Letter).

Key exclusion criteria (9 listed)

history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADLs
History of COPD or oxygen dependence
Pre-existing neurological disorders or dementia
History of major head trauma
Pp between 0.47 and 0.53

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
Incline treadmill walkingThose with a Pp <0.47 or >0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.	Other	Personalized training effect on SSWS and Pp - Incline
Decline treadmill walkingThose with a Pp <0.47 or >0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.	Other	Personalized training effect on SSWS and Pp - Decline
Level Treadmill (Control)Those with a Pp <0.47 or >0.53 will undergo LEVEL training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.	Other	Personalized training effect on SSWS and Pp - Level treadmill (Control)

Primary outcome

Change in Gait Speed
Time frame: Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.
Participants will be asked to complete a 10 Meter Walk Test and a difference will be calculated between pre and post speed.

1 secondary outcome

Change in Paretic Propulsion Symmetry
Time frame: Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.

Results and safety

Results posted to the registry on 22 May 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
Personalized Training Effect on SSWS and Pp - Incline	19	19
Personalized Training Effect on SSWS and Pp - Decline	19	18
Personalized Training Effect on SSWS and Pp - Level Treadmill (Control)	17	17

Primary outcome: Change in Gait Speed

Time frame: Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.. Mean (Standard Deviation). Unit: meters/second

Measure	Personalized Training Effect on SSWS and Pp - Incline n = 19	Personalized Training Effect on SSWS and Pp - Decline n = 18	Personalized Training Effect on SSWS and Pp - Level Treadmill (Control) n = 17
Value	0.15 (0.004)	0.075 (0.053)	0.127 (0.062)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 75 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Personalized Training Effect on SSWS and Pp - Incline	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Personalized Training Effect on SSWS and Pp - Decline	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Personalized Training Effect on SSWS and Pp - Level Treadmill (Control)	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Limitations and caveats (from the sponsor): We did not reach our target number of 60 participants due to the COVID-19 pandemic. The formatting of our study at its conclusion is different than its original presentation. Our 'arms' are updated as the incline, decline, and level treadmill conditions. We present gait speed and Pp outcomes across three conditions in our final report. We caution interpretation due to the potential impact of paretic propulsion baseline characteristic on the response to incline or decline walking conditions.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. As a clinical trial, the details of this project will be entered into ClinicalTrials.gov. Clinical data from assessment sessions will be recorded on hard copies (stored in a locked file cabinet in the Ralph H. Johnson VAMC rehabilitation research space) and entered into a RedCAP electronic database by the project coordinator immediately after each session. These data will be de-identified for further analysis. Only the PI will only have access to de-identified data. Gait data will be analyzed using a custom MATLAB program, automatically populating a LabView Data Viewer from which customized data may be retrieved. The research coordinator will check the data entry, and pool all data into a group-wide de-identified spreadsheet. All data from training sessions will also be analyzed and stored using an automated MATLAB program. All electronic data will be stored on a secure server that is backed-up nightly.

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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.

Brian Cence principal investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

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

Questions about this trial

What is this clinical trial studying?

A study testing Incline treadmill walking and Decline treadmill walking in people with CVA (Cerebrovascular Accident), run by VA Office of Research and Development at 2 sites 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 5 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 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 22 May 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?

Change in Gait Speed (time frame: Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.). 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 NCT03561246.

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 22 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.