Evaluation of the Gigstride wearable device for pain reduction and functional outcomes in patients with lower extremity mobility deficits: a single-arm pilot feasibility study.

Abstract

Background: Mobility deficits are the most common form of disability in the United States and can significantly impair function and activities of daily living. Assistive devices have the potential to reduce physical limitations and support functional independence. This pilot study evaluated the Gigstride wearable device for its effects on pain reduction and gait-related outcomes.

Methods: This prospective, single-arm feasibility study was conducted at a tertiary academic center and included adults ≥18 years with lower extremity deficits. The primary outcome was pain, measured by the Numeric Rating Scale (NRS) during level ambulation and stair climbing. Secondary outcomes included performance on the modified 10-meter walk test with return and the Timed Up and Go (TUG) test. Patient-reported experience and the practicality of implementing the device in a larger-scale study were also assessed.

Results: A total of forty-four patients were enrolled (mean age 66 years; 57% female). Gigstride use significantly reduced pain during level ambulation and stair climbing, with no significant changes in secondary outcomes. Median walking pain decreased by 1 NRS point (p = 0.00032), and stair-related pain decreased by 0.5 NRS points (p = 0.00025).

Conclusion: Gigstride wearable device use appears feasible and may provide modest reductions in mobility-related pain. However, the limited magnitude of pain reduction and absence of functional improvement in this study highlights the need for larger, controlled studies.

Clinical trial registration: The www.ClinicalTrials.gov identifier is NCT06548087.