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RecruitingNCT07043101Updated Jun 29, 2025

Feasibility and Effectiveness of Goal Driven Extended Reality for Lower Limb Rehabilitation

An interventional study of Extended Reality based Gait Rehabilitation in Gait Rehabilitation, sponsored by University at Albany. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-29.

Sponsored by University at Albany · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Gait Rehabilitation

Keywords

  • Inpatient Rehabilitation
  • Augmented Reality
  • Gait Rehabilitation
  • Lower Extremity Function
  • Extended Reality
  • Mixed Reality
  • Virtual Reality
03

In context

Lead sponsor

University at Albany is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Vector Based Gait Rehabilation paired with Extended Reality

    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.

    Other: Extended Reality based Gait Rehabilitation

Interventions

  • OtherExtended Reality based Gait Rehabilitation

    XR headset augmenting traditional Vector based gait rehabilitation.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 months

Secondary outcomes

  1. 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).

    Time frame: 2 months

  2. 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)

    Time frame: 2 months

  3. 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).

    Time frame: 2 months

Other outcomes

  1. Ease of Use, Enjoyability and Comfort

    How easy, enjoyable and comfortable the overall system was for patients to use. Captured through post session survey questions with a 5 point Likert Scale for each (1- Very difficult/Not enjoyable/ Very uncomfortable, 5 - Very Easy/Very Enjoyable/Very comfortable).

    Time frame: 2 months

  2. End of study patient feedback

    Feedback regarding challenges/difficulties, enjoyability, frustrations, and general suggestions. Collected post rehabilitation via a questionnaire.

    Time frame: 2 months

  3. Patient perceived effectiveness and challenge level

    Effectiveness of XR session for patient rehabilitation, along with challenge posed via each task for the patient. Collected via post session survey questions with a 5 point Likert Scale (1-Not Effective/Much more challenging, 5- Very effective/Not challenging at all)

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
  • Sunnyview Rehabilitation Hospital
    Schenectady, New York 12308, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07043101
Lead sponsor
University at Albany
Collaborators
Sunnyview Rehabilitation Hospital
Responsible party
Sponsor
First posted
Jun 29, 2025
Start date
May 12, 2025
Primary completion
Aug 15, 2025 (estimated)
Completion
Aug 15, 2025 (estimated)
Last update
Jun 29, 2025

Study contacts

Jeremy Varghese
Contact
jvarghese2@albany.edu
3124204491
Amy Teale
Contact
Amy.Teale@sphp.com
518-386-3613

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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