NCT06028529 Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease

Eligibility & Interventions

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This trial targets 30 participants in total. It began in 2024-09-01 with a primary completion date of 2026-08-31.

Brief Summary

Physical therapy approaches for balance and walking deficits in Parkinson's disease (PD) have limited effectiveness, with mostly short-lasting benefits. An exoskeleton is a device that straps to the legs and provides a passive force to assist people to better ambulate. The goal of this study is to establish the feasibility and safety of a lightweight exoskeleton on mobility and fall reduction in people with PD. As most PD patients eventually require assistive mobility devices, the exoskeleton represents a new option for increased, mobility, quality of life, and independence. Qualified subjects will come to the clinic twice weekly for eight weeks (16 total visits) and wear the exoskeleton device while walking under the supervision of a trained kinesiotherapist. Study staff will also interview participants and assess their PD symptoms, quality of life, and overall mobility. This study hopes to establish exoskeletons as modern, standard of care devices, which allow people with PD to maintain more independent and productive lives.

Eligibility Criteria

Inclusion Criteria: * PD confirmed by a PADRECC movement disorder specialist using UK Brain Bank Criteria * Modified H\&Y stage II-V * Veteran * Able to attend visits at the Richmond VA Medical Center Exclusion Criteria: * neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of stance, gait, balance or coordination * severe CHF, COPD, or those requiring nasal canula O2 * history of implantable cardiac device or ablative surgery * moderately-severe to severe cognitive impairment / dementia (Montreal Cognitive Assessment \< 17/30) * symptomatic orthostatic hypotension with exertion * feeding tube or associated port placement (PEG/J-PEG) * body height less than 5'1" or greater than 6'3" * body weight greater than 250 pounds * amputation of any portion of the lower limbs * osteoporosis as defined by DEXA Scan T score \< -2.5 * failure to meet B-Temia-established hip and knee flexion and extension manual muscle test (MMT) prerequisite screening parameters, which assure that individuals can adequately engage and walk against the resistive forces of the Keeogo * inability to complete 20 minutes of walking with the exoskeleton (over a maximum period of one hour) at the initial screening/testing session

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