StrokeNCT06638476
Lateral Perturbation Induced Step Training Compared to Lateral Voluntary Step Training in People with Chronic Stroke
A study testing Perturbation Induced Step training and Voluntary step training in people with Stroke, run by Vicki Gray at 1 site in United States.
Trial summary
The goal of this clinical trial is to see if perturbation-induced step training improves stepping performance during a reactive and voluntary step. The main questions it aims to answer are: Does perturbation induced step training improve step initation time and first recovery step? Researchers will compare lateral… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Perturbation Induced Step training and Voluntary step training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2014to 30 Mar 2018
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hemiparesis as a result of a stroke greater than 6 months previous to the study
- Able to walk 10 meters with or without a walking aid
- Have the cognitive ability to give informed consent
Who cannot join
- Medical condition precluding participation in regular exercise, such as acute cardiac or respiratory conditions limiting activity and other health conditions significantly impacting the ability to walk beyond the effects of the stroke, such as other neurological conditions or peripheral neuropathies.
- Bilateral stroke or a previous stroke in the contralateral hemisphere.
- Aphasia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Baltimore
Baltimore, MD, Maryland, 21210
About this study
Official title: Step Training in Persons Post-stroke
The goal of this clinical trial is to see if perturbation-induced step training improves stepping performance during a reactive and voluntary step. The main questions it aims to answer are:
Does perturbation induced step training improve step initation time and first recovery step?
Read more
Researchers will compare lateral perturbation induced step training to lateral voluntary step training to see if the first recovery steps improve.
Participants will:
Vist the lab for an initial assessment, post exercise and one month post exercise of voluntary and perturbation induced stepping performance, and clinical tests of balance, motor recovery, sensory and strength tests.
Exercise 3 times a week for 6 weeks in person
Track falls for 6 months after the exercise.
Read the detailed description
Stroke is the leading cause of disability in the United States as the result of an increased survival rate over the last 25 years. A high frequency of falls is commonly reported in this group due to the residual sensorimotor deficits and impairments to balance. Many falls occur when weight is transferred laterally and an equal number of falls happen during voluntary movements as during unexpected disturbances such as a trip, push or pull. Typically, either will involve a protective step to recover balance. Thus, the purpose of this study is to compare the effects of reactive lateral step training to voluntary lateral step training on the performance of the protective step, functional balance and falls in persons post-stroke. Thirty participants with a stroke will be randomized to one of two interventions, reactive step training or voluntary step training. In the voluntary step training group, participants will perform voluntary steps. In the reactive step training group, participants will perform reactive steps generated by the Active Step. The training will be 3 times a week for 6 weeks. The step initiation time, will be compared in both the voluntary and reactive steps at baseline before the intervention, post-intervention and a test of retention will occur one month after the training. Functional balance will be assessed with the Community Balance \& Mobility Scale and falls will be compared in the 6 months preceding the intervention to 6 months post-intervention testing. If reactive step training is effective, then the protective step characteristics, functional balance and the number of falls will be reduced compared to the voluntary step training group.
- Conditions
- Stroke
- Being tested
- Perturbation Induced Step training, Voluntary step training
- Keywords
- balance, exercise, falls, stroke
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perturbation Induced Step trainingOther
A sudden lateral displacement of the treadmill.
Voluntary step trainingOther
Voluntary steps emphasizing speed, movement of center of mass and taking larger steps.
| Study group | Role | What they receive |
|---|---|---|
| Perturbation induced step training | Experimental | Participants will receive 18 sessions over 6 weeks. Receives: Other: Perturbation Induced Step training |
| Voluntary Step training | Active comparator | Participants will receive 18 sessions over 6 weeks. Receives: Other: Voluntary step training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step initiation time
Change in Step initiation time measured from the time of the puller or light cue onset to the first foot off the force platform.
Measured: Baseline, 6 weeks
First step length
Global step length based on the displacement of the ankle marker normalized by the participants height.
Measured: Baseline, 6 weeks
Secondary outcomes (5)
step velocity
The step displacment divided by the time to complete the first step
Measured: Baseline, 6 weeks
Step clearance
The vertical displacment of the ankle marker normalized the the body height.
Measured: Baseline, 6 weeks
Community Balance & Mobility Scale
Balance measure
Measured: Baseline, 6 weeks
Activities Specific Balance Confidence
A self reported measure of balance confidence
Measured: Baseline, 6 weeks
Falls
Number of falls
Measured: 6 months pre-enrollment, 6 months post exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Sep 2014
- Primary completion30 Sep 2017
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vicki Gray
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vicki Gray, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638476
- Sponsor's protocol ID
- 00056550
- Other IDs
- American Heart Association, H133P100014, H133F140027, P30AG028747
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data was collected more than 5 years ago.
Publications
Lanza MB, Fujimoto M, Magder L, McCombe-Waller S, Rogers MW, Gray VL. Is lateral external perturbation training more beneficial for protective stepping responses than voluntary stepping training in stroke? A pilot randomized control study. J Neuroeng Rehabil. 2024 Nov 5;21(1):199. doi: 10.1186/s12984-024-01495-7.
PubMed 39511544
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step Training in Persons Post-stroke
- ClinicalTrials.gov ID
- NCT06638476
- Acronym / sponsor ID
- 00056550
- Conditions
- Stroke
- Keywords
- balance, exercise, falls, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Vicki GrayUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 15 Oct 2024 (actual)
- 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.
The goal of this clinical trial is to see if perturbation-induced step training improves stepping performance during a reactive and voluntary step. The main questions it aims to answer are:
Does perturbation induced step training improve step initation time and first recovery step?
Researchers will compare lateral perturbation induced step training to lateral voluntary step training to see if the first recovery steps improve.
Participants will:
Vist the lab for an initial assessment, post exercise and one month post exercise of voluntary and perturbation induced stepping performance, and clinical tests of balance, motor recovery, sensory and strength tests.
Exercise 3 times a week for 6 weeks in person
Track falls for 6 months after the exercise.
Detailed description
Stroke is the leading cause of disability in the United States as the result of an increased survival rate over the last 25 years. A high frequency of falls is commonly reported in this group due to the residual sensorimotor deficits and impairments to balance. Many falls occur when weight is transferred laterally and an equal number of falls happen during voluntary movements as during unexpected disturbances such as a trip, push or pull. Typically, either will involve a protective step to recover balance. Thus, the purpose of this study is to compare the effects of reactive lateral step training to voluntary lateral step training on the performance of the protective step, functional balance and falls in persons post-stroke. Thirty participants with a stroke will be randomized to one of two interventions, reactive step training or voluntary step training. In the voluntary step training group, participants will perform voluntary steps. In the reactive step training group, participants will perform reactive steps generated by the Active Step. The training will be 3 times a week for 6 weeks. The step initiation time, will be compared in both the voluntary and reactive steps at baseline before the intervention, post-intervention and a test of retention will occur one month after the training. Functional balance will be assessed with the Community Balance \& Mobility Scale and falls will be compared in the 6 months preceding the intervention to 6 months post-intervention testing. If reactive step training is effective, then the protective step characteristics, functional balance and the number of falls will be reduced compared to the voluntary step training group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perturbation induced step training | Experimental | Other: Perturbation Induced Step trainingParticipants will receive 18 sessions over 6 weeks. |
| Voluntary Step training | Active comparator | Other: Voluntary step trainingParticipants will receive 18 sessions over 6 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hemiparesis as a result of a stroke greater than 6 months previous to the study
- Able to walk 10 meters with or without a walking aid
- Have the cognitive ability to give informed consent
Key exclusion criteria (3 listed)
- Medical condition precluding participation in regular exercise, such as acute cardiac or respiratory conditions limiting activity and other health conditions significantly impacting the ability to walk beyond the effects of the stroke, such as other neurological conditions or peripheral neuropathies.
- Bilateral stroke or a previous stroke in the contralateral hemisphere.
- Aphasia
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 |
|---|---|---|
| Perturbation Induced Step trainingA sudden lateral displacement of the treadmill. | Other | Perturbation induced step training |
| Voluntary step trainingVoluntary steps emphasizing speed, movement of center of mass and taking larger steps. | Other | Voluntary Step training |
Primary outcome
Step initiation time
Time frame: Baseline, 6 weeks
Change in Step initiation time measured from the time of the puller or light cue onset to the first foot off the force platform.
First step length
Time frame: Baseline, 6 weeks
Global step length based on the displacement of the ankle marker normalized by the participants height.
5 secondary outcomes
step velocity
Time frame: Baseline, 6 weeks
Step clearance
Time frame: Baseline, 6 weeks
Community Balance & Mobility Scale
Time frame: Baseline, 6 weeks
Activities Specific Balance Confidence
Time frame: Baseline, 6 weeks
Falls
Time frame: 6 months pre-enrollment, 6 months post exercise
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 16 Oct 2024.
- Derived from this study: PubMed 39511544Lanza MB, Fujimoto M, Magder L, McCombe-Waller S, Rogers MW, Gray VL. Is lateral external perturbation training more beneficial for protective stepping responses than voluntary stepping training in stroke? A pilot randomized control study. J Neuroeng Rehabil. 2024 Nov 5;21(1):199. doi: 10.1186/s12984-024-01495-7.
- Individual participant dataSharing planned: No. The data was collected more than 5 years ago.
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perturbation Induced Step training and Voluntary step training in people with Stroke, run by Vicki Gray 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 3 inclusion and 3 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 16 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?
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?
Step initiation time (time frame: Baseline, 6 weeks). The study lists 2 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 NCT06638476, which also lists 1 linked publication.
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 16 Oct 2024.