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NCT Number: NCT07043101

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnyview Rehabilitation Hospital

Schenectady, New York, 12308, United States

Location status: Recruiting

Location contact

Amy Teale

CONTACT

[email protected]

518-386-3613

Amy Teale

SUB_INVESTIGATOR

Jeremy Varghese

CONTACT

[email protected]

3124204491

Jeremy Varghese

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extended Reality based Gait Rehabilitation

Other

XR headset augmenting traditional Vector based gait rehabilitation.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient Motivation

    Time frame: 2 months

    Track patient motivation over sessions as measured by post session survey response on a 5 point Likert Scale (1-Not motivated, 5 - Very motivated).

  2. Patient Confidence

    Time frame: 2 months

    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)

  3. Patient Satisfaction

    Time frame: 2 months

    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).

Other outcomes

  1. Ease of Use, Enjoyability and Comfort

    Time frame: 2 months

    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).

  2. End of study patient feedback

    Time frame: 2 months

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

  3. Patient perceived effectiveness and challenge level

    Time frame: 2 months

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Teale

CONTACT

[email protected]

518-386-3613

Jeremy Varghese

CONTACT

[email protected]

3124204491

Sponsors and collaborators

Lead sponsor

University at Albany

Other

Collaborators

  • Sunnyview Rehabilitation Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.