StrokeNCT02516176
Sideways Treadmill Training to Improve Paretic Leg Stepping in Persons Post-Stroke
A study testing treadmill training in people with Stroke and Hemiparesis, run by Northwestern University at 1 site in United States.
Trial summary
People who are living in the community following a stroke fall frequently. The ability to take a step in response to a balance disturbance helps to prevent falls but stroke survivors tend not to step with their paretic leg in these circumstances. This leaves them vulnerable to falls towards their paretic side. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- treadmill training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years old
- a stroke survivor for at least 3 months
- able to understand the testing instructions
- able to walk 10 steps independently without an assistive device
- living in the community (at home in an apartment, condo or house).
- may have a history of one or more strokes but must present with one-sided hemiparesis
Who cannot join
- currently participating in physical therapy for balance and gait-training
- other major musculoskeletal or other neurological disorders
- residing in skilled nursing or assisted living facilities.
- other major musculoskeletal or neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility and Efficacy of Induced Lateral Step Treadmill Training to Improve Paretic Limb Stepping Post-Stroke
People who are living in the community following a stroke fall frequently. The ability to take a step in response to a balance disturbance helps to prevent falls but stroke survivors tend not to step with their paretic leg in these circumstances. This leaves them vulnerable to falls towards their paretic side. The purpose of this study is to train paretic limb stepping by having individuals stand sideways on a treadmill and respond to sudden accelerations of the treadmill.
Read the detailed description
Stroke survivors living in the community are at high risk for falling. Falls are considered to be one of the most prevalent post-stroke complications. Fall history in this population has been associated with developing activity limitation, decreased independence and increased fear of falling.
The ability to step in response to an equilibrium disturbance is considered to be critical to prevent a fall. Stroke survivors tend not to step with their paretic limb when their standing equilibrium is perturbed. Training the paretic limb to step in response to perturbations has had limited success in stroke survivors. In response to sagittal plane perturbation training, stroke survivors continued tend to step with their non-paretic leg even when cued or induced to step with paretic leg. This tendency decreases their flexibility to respond to perturbations and also makes it difficult to train the paretic limb.
In contrast, coronal plane perturbations may be a useful way to induce paretic limb stepping. Acceleration and deceleration of a treadmill has been used to train reactive stepping in all directions persons with Parkinson's Disease. Coronal plane perturbations may elicit greater responses from the paretic limb but this has never been investigated in the stroke population.
In this study participants will engage in 6 training sessions over 2-3 weeks. They will stand sideways on the treadmill with their paretic leg towards the front of the treadmill belt, which will be suddenly accelerated for 3 seconds to a predetermined velocity. Participants will perform 80 trials each session under one or more of the following four training conditions.
NON-ENCOURAGED TREADMILL ONLY: These trials are defined as trials when the subject is instructed to respond as necessary to remain on the front half of the treadmill while maintaining their balance without using external supports, but are not given any specific instructions about which limb to use to initiate stepping when the treadmill begins to move.
NON-ENCOURAGED USE TREADMILL PLUS SECONDARY TASK: All the same procedures for non-encouraged use treadmill only trials will be used with the following addition. Just after the subject attains equal weight bearing, the subject will be engaged in a cognitive task to name as many items in a category as they are able. During this time period, the treadmill will be started randomly.
ENCOURAGED USE TREADMILL ONLY TRIALS: These trials are defined as trials where subjects will be instructed to respond as necessary to remain on the front half of the treadmill while maintaining their balance without using external supports AND to initiate stepping with his or her paretic leg when the treadmill begins to move.
ENCOURAGED USE TREADMILL PLUS SECONDARY TASK: All the same procedures for encouraged use treadmill only trials will be used with the following addition. Just after the subject attains equal weight bearing, the subject will be engaged in a cognitive task to name as many items in a category as they are able. During this time period, the treadmill will be started at randomly.
In pilot testing, this protocol has been tolerated by most community dwelling stroke survivors and the encouraged use trials with feedback consistently elicited paretic leg reactive steps.
- Conditions
- Stroke, Hemiparesis
- Being tested
- treadmill training
- Keywords
- stroke, cerebral vascular accident, balance, treadmill, falls, hemiparesis
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treadmill trainingBehavioural
Paretic leg step training while standing on a treadmill sideways and responding to treadmill being turned on suddenly.
| Study group | Role | What they receive |
|---|---|---|
| Treadmill Training | Experimental | Paretic leg step training while standing on a treadmill sideways and responding to treadmill being turned on suddenly. Receives: Behavioral: treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Balance in the Four Square Step Test
The FSST is a timed test that assesses a person's ability to step forwards, sideways, and backwards over canes that are placed on the floor
Measured: change from baseline at 3 weeks - immediately following the training sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lois Deming Hedman, Northwestern University
- Investigators
- Lois D Hedman, DSc PT, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516176
- Sponsor's protocol ID
- STU000200161
- Status last verified
- Mar 2019
- First submitted
- 22 Jul 2015
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Efficacy of Induced Lateral Step Treadmill Training to Improve Paretic Limb Stepping Post-Stroke
- ClinicalTrials.gov ID
- NCT02516176
- Acronym / sponsor ID
- STU000200161
- Conditions
- Stroke, Hemiparesis
- Keywords
- stroke, cerebral vascular accident, balance, treadmill, falls, hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People who are living in the community following a stroke fall frequently. The ability to take a step in response to a balance disturbance helps to prevent falls but stroke survivors tend not to step with their paretic leg in these circumstances. This leaves them vulnerable to falls towards their paretic side. The purpose of this study is to train paretic limb stepping by having individuals stand sideways on a treadmill and respond to sudden accelerations of the treadmill.
Detailed description
Stroke survivors living in the community are at high risk for falling. Falls are considered to be one of the most prevalent post-stroke complications. Fall history in this population has been associated with developing activity limitation, decreased independence and increased fear of falling.
The ability to step in response to an equilibrium disturbance is considered to be critical to prevent a fall. Stroke survivors tend not to step with their paretic limb when their standing equilibrium is perturbed. Training the paretic limb to step in response to perturbations has had limited success in stroke survivors. In response to sagittal plane perturbation training, stroke survivors continued tend to step with their non-paretic leg even when cued or induced to step with paretic leg. This tendency decreases their flexibility to respond to perturbations and also makes it difficult to train the paretic limb.
In contrast, coronal plane perturbations may be a useful way to induce paretic limb stepping. Acceleration and deceleration of a treadmill has been used to train reactive stepping in all directions persons with Parkinson's Disease. Coronal plane perturbations may elicit greater responses from the paretic limb but this has never been investigated in the stroke population.
In this study participants will engage in 6 training sessions over 2-3 weeks. They will stand sideways on the treadmill with their paretic leg towards the front of the treadmill belt, which will be suddenly accelerated for 3 seconds to a predetermined velocity. Participants will perform 80 trials each session under one or more of the following four training conditions.
NON-ENCOURAGED TREADMILL ONLY: These trials are defined as trials when the subject is instructed to respond as necessary to remain on the front half of the treadmill while maintaining their balance without using external supports, but are not given any specific instructions about which limb to use to initiate stepping when the treadmill begins to move.
NON-ENCOURAGED USE TREADMILL PLUS SECONDARY TASK: All the same procedures for non-encouraged use treadmill only trials will be used with the following addition. Just after the subject attains equal weight bearing, the subject will be engaged in a cognitive task to name as many items in a category as they are able. During this time period, the treadmill will be started randomly.
ENCOURAGED USE TREADMILL ONLY TRIALS: These trials are defined as trials where subjects will be instructed to respond as necessary to remain on the front half of the treadmill while maintaining their balance without using external supports AND to initiate stepping with his or her paretic leg when the treadmill begins to move.
ENCOURAGED USE TREADMILL PLUS SECONDARY TASK: All the same procedures for encouraged use treadmill only trials will be used with the following addition. Just after the subject attains equal weight bearing, the subject will be engaged in a cognitive task to name as many items in a category as they are able. During this time period, the treadmill will be started at randomly.
In pilot testing, this protocol has been tolerated by most community dwelling stroke survivors and the encouraged use trials with feedback consistently elicited paretic leg reactive steps.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treadmill Training | Experimental | Behavioral: treadmill trainingParetic leg step training while standing on a treadmill sideways and responding to treadmill being turned on suddenly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- at least 18 years old
- a stroke survivor for at least 3 months
- able to understand the testing instructions
- able to walk 10 steps independently without an assistive device
- living in the community (at home in an apartment, condo or house).
Key exclusion criteria (4 listed)
- currently participating in physical therapy for balance and gait-training
- other major musculoskeletal or other neurological disorders
- residing in skilled nursing or assisted living facilities.
- other major musculoskeletal or neurological disorders
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 |
|---|---|---|
| treadmill trainingParetic leg step training while standing on a treadmill sideways and responding to treadmill being turned on suddenly. | Behavioural | Treadmill Training |
Primary outcome
Dynamic Balance in the Four Square Step Test
Time frame: change from baseline at 3 weeks - immediately following the training sessions
The FSST is a timed test that assesses a person's ability to step forwards, sideways, and backwards over canes that are placed on the floor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Lois D Hedman, DSc PT principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treadmill training in people with Stroke and Hemiparesis, run by Northwestern University 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 6 inclusion and 4 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 13 Mar 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dynamic Balance in the Four Square Step Test (time frame: change from baseline at 3 weeks - immediately following the training sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2019.