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

Feasibility and Effectiveness of Goal Driven Extended Reality for Lower Limb Rehabilitation: A Pilot Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07043101
Enrollment
24
Registered
2025-06-29
Start date
2025-05-12
Completion date
2025-08-15
Last updated
2025-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait Rehabilitation

Keywords

Inpatient Rehabilitation, Augmented Reality, Gait Rehabilitation, Lower Extremity Function, Extended Reality, Mixed Reality, Virtual Reality

Brief 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.

Interventions

OTHERExtended Reality based Gait Rehabilitation

XR headset augmenting traditional Vector based gait rehabilitation.

Sponsors

Sunnyview Rehabilitation Hospital
CollaboratorOTHER
University at Albany
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gait Speed2 monthsEstablish the efficacy of integrating Extended Reality (XR) with Vector treatment sessions during inpatient rehabilitation by monitoring the change in gait speed over sessions.

Secondary

MeasureTime frameDescription
Patient Motivation2 monthsTrack patient motivation over sessions as measured by post session survey response on a 5 point Likert Scale (1-Not motivated, 5 - Very motivated).
Patient Confidence2 monthsPatient 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)
Patient Satisfaction2 monthsMeasure 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).

Other

MeasureTime frameDescription
End of study patient feedback2 monthsFeedback regarding challenges/difficulties, enjoyability, frustrations, and general suggestions. Collected post rehabilitation via a questionnaire.
Patient perceived effectiveness and challenge level2 monthsEffectiveness 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)
Ease of Use, Enjoyability and Comfort2 monthsHow 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).

Countries

United States

Contacts

Primary ContactJeremy Varghese
jvarghese2@albany.edu3124204491
Backup ContactAmy Teale
Amy.Teale@sphp.com518-386-3613

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026