Pilot Study Exploring the Effects of Rhythmic Auditory Stimulation on Gait in People With Motor Incomplete Spinal Cord Injury

Официальное название

Exploring the Effects of Rhythmic Auditory Stimulation on Gait in Motor Incomplete Spinal Cord Injury: A Pilot Study

Обзор

This pilot study aims to evaluate the feasibility and preliminary efficacy of a wearable rhythmic auditory stimulation system, MedRhythms, for improving gait parameters in patients with motor incomplete SCI. Up to 15 participants aged 18 years or older with non-progressive SCI will be enrolled. Participants will complete supervised gait training using the MedRhythms device twice weekly during regularly scheduled physical therapy sessions over a six-week period. The device uses shoe-mounted sensors and headphones to deliver real-time individualized rhythmic auditory cues based on the user's gait pattern. Primary outcome measures include change in walking speed assessed with the 10-Meter Walk Test. Secondary outcomes include walking endurance measured by the 6-Minute Walk Test, gait parameters obtained through GAITRite analysis, and participant-reported outcomes including the Walking Index for Spinal Cord Injury II (WISCI II) and the SCI Quality of Life Satisfaction with Social Roles and Activities measure. Outcomes will be assessed at baseline, post-intervention (6 weeks), and follow-up (12 weeks). Findings from this study will provide preliminary data on the feasibility and potential clinical impact of rhythmic auditory stimulation as an adjunctive gait rehabilitation strategy for individuals with incomplete SCI.

Вмешательства

• Устройство rhythmic auditory stimulation
  The purpose of this study is to evaluate the feasibility and preliminary efficacy of a rhythmic auditory stimulation device (MedRhythms) in improving gait parameters in individuals with chronic, incomplete spinal cord injury (SCI). Participants will train with the device in a supervised, in-clinic setting at Point West Clinic for 6 weeks, completing 2 sessions per week (12 sessions total)

Первичные конечные точки

• 10-Meter Walk Test (10MWT) [Срок оценки: Baseline, post-intervention at 6 weeks and follow-up at 12 weeks]

Вторичные конечные точки (1)

• 6-Minute Walk Test (6MWT) [Срок оценки: baseline, post-intervention at 6 weeks, and follow-up at 12 weeks]

Критерии участия

Критерии включения

• Age ≥18 years old
• Language: English or Spanish only
• Diagnosis: non-progressive spinal cord lesion; classification as either grade C, D, or E SCI based on American Spinal Injury Association (ASIA) Impairment Scale (AIS)
• Able to ambulate at least a contact guard assist level
• Time post injury: ≥6 months
• Cadence: minimum 40 steps/minute with clear heel strike
• Able to consent

Критерии исключения

• Individuals who use an assistive device and are unable to achieve a 2-point walking pattern (left-right-left-right) with an assistive device
• Walks exclusively with a 3-point walking pattern with an assistive device
• Ambulation requiring a knee-ankle-foot orthosis (KAFO)
• Presence of additional neurological or medical processes that contribute to weakness
• Unable to perceive music through the MedRhythyms device

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• UC Davis Point West — Sacramento

Идентификаторы

NCT: NCT07674927 · 2352022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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