StrokeNCT06522477
High Vs Low Intensity Virtual Reality Gait Training in Individuals with Chronic Stroke
A study testing Virtual reality gait training in people with Stroke and Gait Disorders, Neurologic, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this pilot study is to investigate the feasibility of 1) providing virtual reality walking training using a custom developed setup able to be replicated in routine clinical practice and 2) combining the virtual reality training with high-intensity gait training. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Gait Disorders, Neurologic
- What is being tested?
- Virtual reality gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 30 Jun 2026
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral deficits following stroke > 6 months prior; however individuals > 4 months post-stroke are eligible for consenting, but final eligibility and potential enrollment will not occur until > 6 months
- Age 18-85 years
- Weight < 350 pounds
- Able to follow a 3-step command
- Able to ambulate with self-selected gait speeds between 0.01-1.0 m/s without physical assistance, but with below knee bracing and/or assistive device as needed
- Lower extremity Fugl-Meyer < 34
- Medical clearance to participate
Who cannot join
- Evidence of cerebellar ataxia
- Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities
- Currently participating in other physical therapy
- > 50 units of Botox in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis (AFO) within the past three months. Note that participants may be consented prior to 3 months post-injection; however, eligibility will be determined post 3 months.
- Unable to read > 50% of the letters on the 20/70 line of the Snellen Chart with customary eye wear at a distance of 20 feet
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254
About this study
Official title: Feasibility of High and Low Intensity Virtual Reality Gait Training in Individuals with Chronic Stroke: a Pilot Study
The purpose of this pilot study is to investigate the feasibility of 1) providing virtual reality walking training using a custom developed setup able to be replicated in routine clinical practice and 2) combining the virtual reality training with high-intensity gait training.
Read the detailed description
This study will utilize a randomized-crossover design. Following confirmation of eligibility and completion of Baseline 1 testing, individuals will be randomized to receive up to 15 visits over approximately 5 weeks of either high or low intensity virtual reality gait training. Following which, individuals will undergo Post 1 testing to capture potential change in outcomes following the intervention. Participants will then take at least a 4-week break before returning to complete Baseline 2 testing and up 15 visits over 5 weeks of the alternative intervention before finally completing Post 2 testing.
- Conditions
- Stroke, Gait Disorders, Neurologic
- Being tested
- Virtual reality gait training
- Keywords
- stroke, gait, rehabilitation, high-intensity, virtual reality
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality gait trainingOther
Individuals will walk on a treadmill with overhead harness system in place while viewing 1st-person perspective walking videos on a television placed immediately in front of the treadmill.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity followed by low-intensity virtual reality gait training | Experimental | Individuals randomized to this group will first perform high-intensity virtual reality gait training and following a 4-week washout period will complete low-intensity virtual reality gait training. Receives: Other: Virtual reality gait training |
| Low-intensity followed by high-intensity virtual reality gait training | Experimental | Individuals randomized to this group will first perform low-intensity virtual reality gait training and following a 4-week washout period will complete high-intensity virtual reality gait training. Receives: Other: Virtual reality gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
This is an assessment of overground walking speed measured across a distance of ~20 feet and will be conducted at both self-selected (instructions: "walk at your usual, comfortable pace") and fastest (instructions: "walk as fast as you safely can") walking speeds.
Measured: After 5 weeks of training
6 minute walk test
Individuals will be asked to "cover as much ground as possible" over a six minute period.
Measured: After 5 weeks of training
Peak treadmill speed
Individuals will participate in a walking-based graded exercise test. While harnessed for safety on a treadmill, the treadmill will be initially set to 0.1 m/s and increased by 0.1 m/s each minute until the test is terminated due to one of the following: 1) the participant requests to stop, 2) the participant is unable to keep up with the speed of the treadmill and/or loses their balance, 3) any of the absolute exercise test termination criteria provided by American College of Sports Medicine are present. The highest speed that the individual can walk for a minute at is the peak treadmill speed.
Measured: After 5 weeks of training
Secondary outcomes (6)
Mini Balance Evaluation Systems Test
14 item assessment of static and dynamic balance. Example tasks include sit to stand, stand on one leg, standing stepping reactions, and walking with head turns.
Measured: After 5 weeks of training
Steps per Day
Participants will wear a research-grade pedometer (StepWatch; Modus Health) during waking hours for ~1-2 weeks before beginning each training protocol and after completing training protocol to quantify home and community mobility.
Measured: After 5 weeks of training
30 second Sit to Stand Test
Participants will be asked to rise from a chair without using their arms and then return to sitting as many times as possible in 30 seconds.
Measured: After 5 weeks of training
Activity-Specific Balance Confidence (ABC) Scale
This questionnaire asks individuals to rate their balance-confidence from 0 (no confidence) to 100 (completely confident) during a variety of 16 commonly performed tasks such as walking around a house or getting into a car.
Measured: After 5 weeks of training
Medical Outcomes Survey Short-Form 36 (SF-36)
This 36-question survey asks individuals about how their current health may limit their ability to perform typical physical and social activities. Scores range from 0 (negative health) to 100 (positive health).
Measured: After 5 weeks of training
Oxygen Consumption
Oxygen consumption will be measured via a portable metabolic cart (K5; COSMED) during the previously described graded exercise test. Participant will wear a snug fitting mask that covers their mouth and nose, but does not affect the amount or quality of air that they breathe. The mask will be connected to a small backpack that collects information on the rate of breathing and oxygen consumed.
Measured: After 5 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Why it stopped: Did not receive funding
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 Indiana 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
- Randomised
- Intervention model
- Crossover
- Model description
- Individuals will be randomly assigned to receive up to 15 visits/5 weeks of high- or low-intensity virtual reality gait training. Following a 4 week washout, they will complete the alternative intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Henderson, Indiana University
- Investigators
- Christopher Henderson, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522477
- Sponsor's protocol ID
- 23656
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of High and Low Intensity Virtual Reality Gait Training in Individuals with Chronic Stroke: a Pilot Study
- ClinicalTrials.gov ID
- NCT06522477
- Acronym / sponsor ID
- 23656
- Conditions
- Stroke, Gait Disorders, Neurologic
- Keywords
- stroke, gait, rehabilitation, high-intensity, virtual reality
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not receive funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Jul 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 purpose of this pilot study is to investigate the feasibility of 1) providing virtual reality walking training using a custom developed setup able to be replicated in routine clinical practice and 2) combining the virtual reality training with high-intensity gait training.
Detailed description
This study will utilize a randomized-crossover design. Following confirmation of eligibility and completion of Baseline 1 testing, individuals will be randomized to receive up to 15 visits over approximately 5 weeks of either high or low intensity virtual reality gait training. Following which, individuals will undergo Post 1 testing to capture potential change in outcomes following the intervention. Participants will then take at least a 4-week break before returning to complete Baseline 2 testing and up 15 visits over 5 weeks of the alternative intervention before finally completing Post 2 testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Individuals will be randomly assigned to receive up to 15 visits/5 weeks of high- or low-intensity virtual reality gait training. Following a 4 week washout, they will complete the alternative intervention.
| Arm | Type | Receives |
|---|---|---|
| High-intensity followed by low-intensity virtual reality gait training | Experimental | Other: Virtual reality gait trainingIndividuals randomized to this group will first perform high-intensity virtual reality gait training and following a 4-week washout period will complete low-intensity virtual reality gait training. |
| Low-intensity followed by high-intensity virtual reality gait training | Experimental | Other: Virtual reality gait trainingIndividuals randomized to this group will first perform low-intensity virtual reality gait training and following a 4-week washout period will complete high-intensity virtual reality gait training. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Unilateral deficits following stroke > 6 months prior; however individuals > 4 months post-stroke are eligible for consenting, but final eligibility and potential enrollment will not occur until > 6 months
- Age 18-85 years
- Weight < 350 pounds
- Able to follow a 3-step command
- Able to ambulate with self-selected gait speeds between 0.01-1.0 m/s without physical assistance, but with below knee bracing and/or assistive device as needed
Key exclusion criteria (5 listed)
- Evidence of cerebellar ataxia
- Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities
- Currently participating in other physical therapy
- > 50 units of Botox in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis (AFO) within the past three months. Note that participants may be consented prior to 3 months post-injection; however, eligibility will be determined post 3 months.
- Unable to read > 50% of the letters on the 20/70 line of the Snellen Chart with customary eye wear at a distance of 20 feet
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 |
|---|---|---|
| Virtual reality gait trainingIndividuals will walk on a treadmill with overhead harness system in place while viewing 1st-person perspective walking videos on a television placed immediately in front of the treadmill. | Other | High-intensity followed by low-intensity virtual reality gait training, Low-intensity followed by high-intensity virtual reality gait training |
Primary outcome
Gait speed
Time frame: After 5 weeks of training
This is an assessment of overground walking speed measured across a distance of ~20 feet and will be conducted at both self-selected (instructions: "walk at your usual, comfortable pace") and fastest (instructions: "walk as fast as you safely can") walking speeds.
6 minute walk test
Time frame: After 5 weeks of training
Individuals will be asked to "cover as much ground as possible" over a six minute period.
Peak treadmill speed
Time frame: After 5 weeks of training
Individuals will participate in a walking-based graded exercise test. While harnessed for safety on a treadmill, the treadmill will be initially set to 0.1 m/s and increased by 0.1 m/s each minute until the test is terminated due to one of the following: 1) the participant requests to stop, 2) the participant is unable to keep up with the speed of the treadmill and/or loses their balance, 3) any of the absolute exercise test termination criteria provided by American College of Sports Medicine are present. The highest speed that the individual can walk for a minute at is the peak treadmill speed.
6 secondary outcomes
Mini Balance Evaluation Systems Test
Time frame: After 5 weeks of training
Steps per Day
Time frame: After 5 weeks of training
30 second Sit to Stand Test
Time frame: After 5 weeks of training
Activity-Specific Balance Confidence (ABC) Scale
Time frame: After 5 weeks of training
Medical Outcomes Survey Short-Form 36 (SF-36)
Time frame: After 5 weeks of training
Oxygen Consumption
Time frame: After 5 weeks of training
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: Yes. De-identified data available upon reasonable request
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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.
Christopher Henderson, PhD principal investigator
Indiana 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 Virtual reality gait training in people with Stroke and Gait Disorders, Neurologic, run by Indiana 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 7 inclusion and 5 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: withdrawn, as of the sponsor's last update on 18 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 was withdrawn before enrolling participants, so there are no results.
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?
Gait speed (time frame: After 5 weeks of training). 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?
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 18 Oct 2024.