StrokeNCT04112173
Fall-recovery Training for Those With Chronic Stroke and Low Falls Self-efficacy
A study testing perturbation-based fall-recovery training in people with Stroke, run by University of Delaware at 1 site in United States.
Trial summary
Chronic stroke is the leading cause of long-term disability in the United States. Post-stroke health is negatively impacted by two interrelated factors-a substantial risk of falls and limited walking activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- perturbation-based fall-recovery training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2020to 13 Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be 18 years or older
- Participants must have had a single stroke of non-cerebellar origin, occurring six or more months prior to study enrollment.
- An Activities-Specific Balance Confidence (ABC) score less than 68.
Who cannot join
- More than one stroke
- Acute illness at the time of functional assessment or training
- Body mass greater than 136 kg (300 lbs) to ensure that the treadmill accelerates accurately
- Lower extremity joint replacement or shoulder joint replacement within a year prior to participation
- Dementia
- Parkinson's disease
Show all 20Show fewer
- A history of back surgery
- A history of neck surgery
- More than one occurrence of back or neck pain in the month prior to participation
- Current back or neck pain at the time of participant enrollment
- Bulging vertebral discs
- Spine, hip, or lower extremity fracture within a year prior to participation
- Open lesions on the lower extremity
- Insulin-dependent diabetes
- Use of a pacemaker
- Use of an ostomy pouch
- Pregnancy
- Osteoporosis
- Doctor recommendation to avoid moderate physical activity or exercise
- Any neural, muscular, or skeletal condition or injury that precludes safe participation in the training or introduces a confounding factor on the study, at the discretion of the clinician or study staff
Trial locations and contacts
1 site in 1 country.
About this study
Chronic stroke is the leading cause of long-term disability in the United States. Post-stroke health is negatively impacted by two interrelated factors-a substantial risk of falls and limited walking activity. The risk of falling is a barrier to walking activity, with falls self-efficacy mediating the relationship between impaired physical capacity and limited activity. The ability to recover from a fall (i.e. arrest a fall before impact) is a logical, yet untested rehabilitation target to enable walking activity through sustained benefits to falls self-efficacy. Our aim is to demonstrate that fall-recovery training is feasible in stroke survivors with low falls self-efficacy. Five participants will undergo an adapted version of fall-recovery training. We will gather evidence of the implementation, adaptation, and limited efficacy of this intervention in affecting falls self-efficacy and walking activity.
Read the detailed description
The study aim is to demonstrate that fall-recovery training is feasible in stroke survivors with low falls self-efficacy. We will gather evidence of the adaptation, implementation, and limited efficacy of our intervention. This aim will be addressed with a single-group, interventional study. At baseline, fall-recovery ability will be determined from stepping thresholds in response to treadmill-delivered perturbations. Falls self-efficacy will be determined from questionnaires. Walking activity will be recorded using step counters (StepWatchTM). After three weeks of a non-active control period, we will repeat assessments. Then, participants will attend six training sessions consisting of anterior, posterior, and lateral perturbations. After training, we will repeat all assessments of balance, self-efficacy, and walking activity. We will recruit five participants with chronic stroke (i.e. >6 months after stroke). Falls self-efficacy is recorded upon registry enrollment, allowing us to recruit to our study needs. All participants must have an Activities-Specific Balance Confidence (ABC) score less than 68. Upon enrollment, the Fugl-Meyer Lower Extremity assessment and Stroke Impact Scale will be administered. Fall-recovery ability will be quantified from anterior, posterior, and lateral single-stepping thresholds. Participants will be outfitted with a harness attached to an overhead rail. As they stand on a computer-controlled treadmill (ActiveStep®, Simbex), participants will be instructed to not step in response to rapid belt translations. For each opposing pair of thresholds, a progressively challenging series of perturbations will be delivered. Thresholds are defined as the perturbation magnitudes that consistently elicit one step. Falls self-efficacy will be quantified from the ABC scale and the Falls Efficacy Scale (FES). Walking activity will be quantified as average daily steps, recorded in five-second intervals for one week by a StepWatchTM monitor on the non-paretic ankle.
Our fall-recovery training consists of 6 sessions over 3-4 weeks, each consisting of the following 5-minute series:
- Standing perturbations that induce a forward fall, necessitating multiple steps to regain stability. Separate series will focus on paretic and non-paretic steps. Participants will be instructed to "try not to fall".
- Standing perturbations that induce a backwards fall. Instructions will be to recover in a single step. This constraint is added because, unlike the multiple-step response of trip recoveries, slip recovery is dictated by first-step features. Separate series will focus on initial steps with the paretic or non-paretic limb.
- Standing perturbations that induce a lateral fall, delivered as participants stand facing the side of the treadmill. Participants will be instructed to "try not to fall". We will apply left and right perturbations large enough to elicit a step.
- Also, we will apply anterior and posterior perturbations as the participants walk. Our treadmill is equipped to deliver perturbations timed relative to foot strikes during gait.
The training intensity, as determined by the perturbation size and, if applicable, gait speed, will be small at first, progressing to more challenging levels dependent upon participant performance, safety, and comfort.
As per feasibility-study guidelines, we will gather evidence of adaptation, implementation, and limited efficacy.
- Conditions
- Stroke
- Being tested
- perturbation-based fall-recovery training
- Keywords
- balance, self-efficacy, exercise, postural control
- 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-based fall-recovery trainingBehavioural
Also called balance training
Participants will attempt to recover from treadmill-induced balance perturbations as they walk or stand. The size of the perturbations is progressively challenging and dependent upon participant performance.
| Study group | Role | What they receive |
|---|---|---|
| Perturbation-Based Balance Training | Experimental | perturbation-based balance training Receives: Behavioral: perturbation-based fall-recovery training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events Ending Participation
The number of participants who end participation due to adverse events
Measured: 6 months
Activities Specific Balance Confidence Questionnaire Score.
Balance confidence, as measured by the Activities Specific Balance Confidence questionnaire. Scores range from 0 to 100, and represent the average rating of each question. Higher scores indicate more confidence.
Range 0-100
Higher values represent a better outcome.
Measured: 6 months
Falls Self-Efficacy Scale Score
Falls Self-Efficacy, as measured by the Falls Self-Efficacy Scale. Scores are totaled, ranging from 16-64, with higher scores representing worse self-efficacy.
Measured: 6 months
Walking Activity
Average steps/day, as measured by a step monitor
Measured: 6 months
Secondary outcomes (1)
Stepping Threshold Assessment of Reactive Balance
Stepping thresholds are the treadmill-induced, standing perturbation magnitudes that elicit anterior, posterior, or lateral steps. These thresholds are determined from a series of progressively challenging perturbations, delivered as participants stand on a computer-controlled treadmill. The thresholds are the size of the perturbation (measured as acceleration) that results in a step for four trial. Participants are instructed to try not to step. One progression consists of forward and backward perturbations to determine anterior and posterior thresholds. A second progression is done with participants facing the side of the treadmill, with the progression identifying left and right stepping thresholds. Anterior, posterior, left, and right thresholds are considered independently (i.e. not averaged or summed).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start21 Feb 2020
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Why it stopped: Study activity has initially suspended due to COVID-19 restrictions, but it will not resume due to the confounding influence of the pandemic on the study outcomes. The feasibility of the study protocol is limited with restrictions from the pandemic.
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 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
- Not applicable
- Intervention model
- Single group
- Model description
- single-group, observational study
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Jeremy Crenshaw, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112173
- Sponsor's protocol ID
- 1490979-1
- Other IDs
- U54GM104941
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2019
- Last updated
- 25 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fall-recovery Training for Those With Chronic Stroke and Low Falls Self-efficacy
- ClinicalTrials.gov ID
- NCT04112173
- Acronym / sponsor ID
- 1490979-1
- Conditions
- Stroke
- Keywords
- balance, self-efficacy, exercise, postural control
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study activity has initially suspended due to COVID-19 restrictions, but it will not resume due to the confounding influence of the pandemic on the study outcomes. The feasibility of the study protocol is limited with restrictions from the pandemic.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Posted 1 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic stroke is the leading cause of long-term disability in the United States. Post-stroke health is negatively impacted by two interrelated factors-a substantial risk of falls and limited walking activity. The risk of falling is a barrier to walking activity, with falls self-efficacy mediating the relationship between impaired physical capacity and limited activity. The ability to recover from a fall (i.e. arrest a fall before impact) is a logical, yet untested rehabilitation target to enable walking activity through sustained benefits to falls self-efficacy. Our aim is to demonstrate that fall-recovery training is feasible in stroke survivors with low falls self-efficacy. Five participants will undergo an adapted version of fall-recovery training. We will gather evidence of the implementation, adaptation, and limited efficacy of this intervention in affecting falls self-efficacy and walking activity.
Detailed description
The study aim is to demonstrate that fall-recovery training is feasible in stroke survivors with low falls self-efficacy. We will gather evidence of the adaptation, implementation, and limited efficacy of our intervention. This aim will be addressed with a single-group, interventional study. At baseline, fall-recovery ability will be determined from stepping thresholds in response to treadmill-delivered perturbations. Falls self-efficacy will be determined from questionnaires. Walking activity will be recorded using step counters (StepWatchTM). After three weeks of a non-active control period, we will repeat assessments. Then, participants will attend six training sessions consisting of anterior, posterior, and lateral perturbations. After training, we will repeat all assessments of balance, self-efficacy, and walking activity. We will recruit five participants with chronic stroke (i.e. >6 months after stroke). Falls self-efficacy is recorded upon registry enrollment, allowing us to recruit to our study needs. All participants must have an Activities-Specific Balance Confidence (ABC) score less than 68. Upon enrollment, the Fugl-Meyer Lower Extremity assessment and Stroke Impact Scale will be administered. Fall-recovery ability will be quantified from anterior, posterior, and lateral single-stepping thresholds. Participants will be outfitted with a harness attached to an overhead rail. As they stand on a computer-controlled treadmill (ActiveStep®, Simbex), participants will be instructed to not step in response to rapid belt translations. For each opposing pair of thresholds, a progressively challenging series of perturbations will be delivered. Thresholds are defined as the perturbation magnitudes that consistently elicit one step. Falls self-efficacy will be quantified from the ABC scale and the Falls Efficacy Scale (FES). Walking activity will be quantified as average daily steps, recorded in five-second intervals for one week by a StepWatchTM monitor on the non-paretic ankle.
Our fall-recovery training consists of 6 sessions over 3-4 weeks, each consisting of the following 5-minute series:
- Standing perturbations that induce a forward fall, necessitating multiple steps to regain stability. Separate series will focus on paretic and non-paretic steps. Participants will be instructed to "try not to fall".
- Standing perturbations that induce a backwards fall. Instructions will be to recover in a single step. This constraint is added because, unlike the multiple-step response of trip recoveries, slip recovery is dictated by first-step features. Separate series will focus on initial steps with the paretic or non-paretic limb.
- Standing perturbations that induce a lateral fall, delivered as participants stand facing the side of the treadmill. Participants will be instructed to "try not to fall". We will apply left and right perturbations large enough to elicit a step.
- Also, we will apply anterior and posterior perturbations as the participants walk. Our treadmill is equipped to deliver perturbations timed relative to foot strikes during gait.
The training intensity, as determined by the perturbation size and, if applicable, gait speed, will be small at first, progressing to more challenging levels dependent upon participant performance, safety, and comfort.
As per feasibility-study guidelines, we will gather evidence of adaptation, implementation, and limited efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-group, observational study
| Arm | Type | Receives |
|---|---|---|
| Perturbation-Based Balance Training | Experimental | Behavioral: perturbation-based fall-recovery trainingperturbation-based balance training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be 18 years or older
- Participants must have had a single stroke of non-cerebellar origin, occurring six or more months prior to study enrollment.
- An Activities-Specific Balance Confidence (ABC) score less than 68.
Key exclusion criteria (20 listed)
- More than one stroke
- Acute illness at the time of functional assessment or training
- Body mass greater than 136 kg (300 lbs) to ensure that the treadmill accelerates accurately
- Lower extremity joint replacement or shoulder joint replacement within a year prior to participation
- Dementia
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-based fall-recovery trainingAlso: balance trainingParticipants will attempt to recover from treadmill-induced balance perturbations as they walk or stand. The size of the perturbations is progressively challenging and dependent upon participant performance. | Behavioural | Perturbation-Based Balance Training |
Primary outcome
Adverse Events Ending Participation
Time frame: 6 months
The number of participants who end participation due to adverse events
Activities Specific Balance Confidence Questionnaire Score.
Time frame: 6 months
Balance confidence, as measured by the Activities Specific Balance Confidence questionnaire. Scores range from 0 to 100, and represent the average rating of each question. Higher scores indicate more confidence. Range 0-100 Higher values represent a better outcome.
Falls Self-Efficacy Scale Score
Time frame: 6 months
Falls Self-Efficacy, as measured by the Falls Self-Efficacy Scale. Scores are totaled, ranging from 16-64, with higher scores representing worse self-efficacy.
Walking Activity
Time frame: 6 months
Average steps/day, as measured by a step monitor
1 secondary outcome
Stepping Threshold Assessment of Reactive Balance
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
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-based fall-recovery training 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 3 inclusion and 20 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: stopped early, as of the sponsor's last update on 25 Sep 2023. 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 1 Dec 2022). 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?
Adverse Events Ending Participation (time frame: 6 months). The study lists 4 primary outcomes in all. 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 25 Sep 2023.