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

NCT07043101 | Recruiting

• 1 other identifier: 25-0312-3
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gait Rehabilitation

Keywords

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

Outcome Measures

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.

  2 months

Secondary Outcomes (3)

• Patient Motivation

  2 months

• Patient Confidence

  2 months

• Patient Satisfaction

  2 months

Other Outcomes (3)

• Ease of Use, Enjoyability and Comfort

  2 months

• End of study patient feedback

  2 months

• Patient perceived effectiveness and challenge level

  2 months

Study Arms (1)

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.

Other: Extended Reality based Gait Rehabilitation

Interventions

Extended Reality based Gait Rehabilitation OTHER

XR headset augmenting traditional Vector based gait rehabilitation.

Vector Based Gait Rehabilation paired with Extended Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatient at Sunnyview Rehabilitation Hospital
• Receiving or scheduled to receive Vector-based gait training therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• University at Albany: lead
• Sunnyview Rehabilitation Hospital: collaborator

Study Sites (1)

Sunnyview Rehabilitation Hospital

Schenectady, New York, 12308, United States

RECRUITING

Central Study Contacts

Jeremy Varghese

CONTACT

3124204491; jvarghese2@albany.edu

Amy Teale

CONTACT

518-386-3613; Amy.Teale@sphp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: June 29, 2025
• Study Start: May 12, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)