Gait RehabilitationNCT07043101
Feasibility and Effectiveness of Goal Driven Extended Reality for Lower Limb Rehabilitation
A study testing Extended Reality based Gait Rehabilitation in people with Gait Rehabilitation, run by University at Albany at 1 site in United States.
Trial summary
This pilot study will evaluate the feasibility and preliminary effectiveness of incorporating Extended Reality (XR) into the treatment of patients undergoing Lower Limb Rehabilitation (LLR) using the Vector Gait and Safety System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gait Rehabilitation
- What is being tested?
- Extended Reality based Gait Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2025to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Inpatient at Sunnyview Rehabilitation Hospital
- Receiving or scheduled to receive Vector-based gait training therapy
- At least 18 years of age at the time of enrollment Exclusion Criteria
- Unable to use the Vector due to contraindications for Vector use (>500 lb or <30 lb), external halo neck support, severe osteoporosis, uncontrolled diabetes, uncontrolled hypertension, unstable fractures)
- Unable to follow 2 step commands
- Vertigo or vision abnormalities contraindicated for MR use
- Unable to ambulate prior to current injury
- In the judgment of the clinician, is not a good fit for the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sunnyview Rehabilitation Hospital
Schenectady, New York, 12308
Amy Teale, 518-386-3613, Amy.Teale@sphp.com
Jeremy Varghese, 3124204491, jvarghese2@albany.edu
About this study
Official title: Feasibility and Effectiveness of Goal Driven Extended Reality for Lower Limb Rehabilitation: A Pilot Study
This pilot study will evaluate the feasibility and preliminary effectiveness of incorporating Extended Reality (XR) into the treatment of patients undergoing Lower Limb Rehabilitation (LLR) using the Vector Gait and Safety System. LLR requires repetitive motions over the span of weeks or months with the aim of restoring mobility. This duration of time poses challenges with motivation and increases the burden on the physical therapists. The use of XR in conjunction with conventional physical therapy could significantly increase motivation, along with providing therapists with new ways of tracking the patient's recovery. Pilot study results will be used to propose new and innovative approaches to physical recovery during inpatient rehabilitation, potentially increasing motivation, enhancing therapy participation, and reducing the overall time taken for recovery.
- Conditions
- Gait Rehabilitation
- Being tested
- Extended Reality based Gait Rehabilitation
- Keywords
- Inpatient Rehabilitation, Augmented Reality, Gait Rehabilitation, Lower Extremity Function, Extended Reality, Mixed Reality, Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Reality based Gait RehabilitationOther
XR headset augmenting traditional Vector based gait rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Vector Based Gait Rehabilation paired with Extended Reality | Experimental | Individuals receiving Vector-based therapy will also receive Extended Reality (XR) during Vector sessions. The Extended Reality consists of mobility based tasks spaced along the Vector track that are executed through the XR headset. Receives: Other: Extended Reality based Gait Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed
Establish the efficacy of integrating Extended Reality (XR) with Vector treatment sessions during inpatient rehabilitation by monitoring the change in gait speed over sessions.
Measured: 2 months
Secondary outcomes (3)
Patient Motivation
Track patient motivation over sessions as measured by post session survey response on a 5 point Likert Scale (1-Not motivated, 5 - Very motivated).
Measured: 2 months
Patient Confidence
Patient confidence in their rehabilitation while using the XR system. Measured by collecting patient feedback on post session survey using a 5 point Likert Scale (1- Not confident, 5- Very confident)
Measured: 2 months
Patient Satisfaction
Measure how satisfied patient is with their recovery using the XR system. Captured using post session survey question with a 5 point Likert Scale (1-Very dissatisfied, 5- Very satisfied).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start12 May 2025
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait RehabilitationStudies 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
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University at Albany
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnyview Rehabilitation Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043101
- Sponsor's protocol ID
- 25-0312-3
- Status last verified
- Jun 2025
- First submitted
- 9 May 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- 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 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of Goal Driven Extended Reality for Lower Limb Rehabilitation: A Pilot Study
- ClinicalTrials.gov ID
- NCT07043101
- Acronym / sponsor ID
- 25-0312-3
- Conditions
- Gait Rehabilitation
- Keywords
- Inpatient Rehabilitation, Augmented Reality, Gait Rehabilitation, Lower Extremity Function, Extended Reality, Mixed Reality, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University at AlbanyUniversity, hospital or other
- Collaborators
- Sunnyview Rehabilitation Hospital
- Study start
- 12 May 2025 (actual)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 29 Jun 2025 (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.
This pilot study will evaluate the feasibility and preliminary effectiveness of incorporating Extended Reality (XR) into the treatment of patients undergoing Lower Limb Rehabilitation (LLR) using the Vector Gait and Safety System. LLR requires repetitive motions over the span of weeks or months with the aim of restoring mobility. This duration of time poses challenges with motivation and increases the burden on the physical therapists. The use of XR in conjunction with conventional physical therapy could significantly increase motivation, along with providing therapists with new ways of tracking the patient's recovery. Pilot study results will be used to propose new and innovative approaches to physical recovery during inpatient rehabilitation, potentially increasing motivation, enhancing therapy participation, and reducing the overall time taken for recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vector Based Gait Rehabilation paired with Extended Reality | Experimental | Other: Extended Reality based Gait RehabilitationIndividuals receiving Vector-based therapy will also receive Extended Reality (XR) during Vector sessions. The Extended Reality consists of mobility based tasks spaced along the Vector track that are executed through the XR headset. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Inpatient at Sunnyview Rehabilitation Hospital
- Receiving or scheduled to receive Vector-based gait training therapy
- At least 18 years of age at the time of enrollment Exclusion Criteria
- Unable to use the Vector due to contraindications for Vector use (>500 lb or <30 lb), external halo neck support, severe osteoporosis, uncontrolled diabetes, uncontrolled hypertension, unstable fractures)
- Unable to follow 2 step commands
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Extended Reality based Gait RehabilitationXR headset augmenting traditional Vector based gait rehabilitation. | Other | Vector Based Gait Rehabilation paired with Extended Reality |
Primary outcome
Gait Speed
Time frame: 2 months
Establish the efficacy of integrating Extended Reality (XR) with Vector treatment sessions during inpatient rehabilitation by monitoring the change in gait speed over sessions.
3 secondary outcomes
Patient Motivation
Time frame: 2 months
Patient Confidence
Time frame: 2 months
Patient Satisfaction
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended Reality based Gait Rehabilitation in people with Gait Rehabilitation, run by University at Albany 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 8 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 29 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeremy Varghese (3124204491, jvarghese2@albany.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Speed (time frame: 2 months). 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 29 Jun 2025.