Evaluation of a Home-based AOMI Intervention on Cognitive Function and Depression Among Adults with SCI

Официальное название

Evaluation of a Home-based Action Observation and Motor Imagery Intervention on Cognitive Function and Depression Among Adults with Spinal Cord Injury: a Pilot Randomized Controlled Trial

Обзор

The investigators propose a pilot randomized clinical trial to determine if adults with spinal cord injury (SCI) show improved cognitive function and depression following home-based Action Observation and Motor Imagery (AOMI) training. It is hypothesized that the home-based AOMI intervention will show satisfactory feasibility and acceptability. They also hypothesize that AOMI training can be used as a rehabilitative tool for improving cognitive function and depression in adults with SCI, because it engages and strengthens similar neural systems as actual exercise.

Подробное описание

This study is an assessor-blinded, two-arm pilot randomized controlled trial with repeated measures (pre-, post-intervention, and 1-month follow-up). This study aims to evaluate the preliminary effects of a home-based AOMI intervention on SCI adults' cognitive function and depression. Forty-six SCI adults will be randomized into the intervention group, receiving an 8-week AOMI intervention combined with basic wheelchair exercises, or the control group, receiving basic wheelchair exercises with the same duration, number of sessions, and frequency as the intervention group. One-on-one qualitative interviews will be implemented post-intervention to evaluate participants' feelings about the effectiveness of their cognitive function and emotional status, their views about opinions of the study's acceptability, strengths, limits, and recommendations for further improvement of the program. The primary outcomes of intervention effectiveness include cognitive function and depression; secondary outcomes include multi-model magnetic resonance imaging (MRI) acquisition, chronic pain, motor imagery ability, and self-efficacy for exercise.

Вмешательства

• Поведенческое Action Observation and Motor Imagery (AOMI) training
  Participants will watch home-based exercise videos and simultaneously imagine themselves performing these exercises in their minds by following verbal instructions in the videos, without actual execution.
• Поведенческое Basic wheelchair exercises
  A set of low-intensity warm-up wheelchair exercises developed specifically for survivors with spinal cord injury
• Поведенческое Watch landscape videos
  A set of landscape videos

Первичные конечные точки

• Recruitment rate [Срок оценки: Pre-intervention]
• Retention rate [Срок оценки: 1-month follow-up]
• Dropout rate [Срок оценки: 1-month follow-up]
• Number of participants with adverse events [Срок оценки: During the intervention]
• Intervention satisfaction [Срок оценки: Immediately after intervention (an average of two months)]
• Adherence rate [Срок оценки: Immediately after intervention (an average of two months)]
• Global cognitive function [Срок оценки: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]
• Depression [Срок оценки: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]

Вторичные конечные точки (12)

• The Digit Span Test [Forward Span] [Срок оценки: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]
• The Digit Span Tests [Backward Span] [Срок оценки: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]
• The Stroop Color Word Test [Срок оценки: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]
• The oral version of the Symbol Digit Modalities Test [Срок оценки: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]
• Change in gray matter cortical thickness [Срок оценки: Baseline, immediately after intervention (an average of two months)]
• Change in white matter integrity [Срок оценки: Baseline, immediately after intervention (an average of two months)]
• Change in white matter hyperintensities [Срок оценки: Baseline, immediately after intervention (an average of two months)]
• Change in Blood-oxygen-level-dependent (BOLD) signal during Action Observation and Motor Imagery task conditions [Срок оценки: Baseline, immediately after intervention (an average of two months)]
• Change in functional connectivity features or neural networks [Срок оценки: Baseline, immediately after intervention (an average of two months)]
• Pain [Срок оценки: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]
• Self-efficacy for exercise [Срок оценки: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]
• Motor imagery ability [Срок оценки: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]

Критерии участия

Критерии включения

• Diagnosis of SCI according to the International Standards for the Neurological Classification of SCI with confirmation by computed tomography/magnetic resonance imaging;
• At least 18 years old;
• With stable spinal systems and good vital signs, and currently living in the community and having SCI for more than 6 months;
• No contraindications to undergoing MRI examination (e.g., no metal or electronic devices in the body, not pregnant, and absence of claustrophobia);
• Having a mobile Internet terminal (usually a smartphone) and proficient independent or caregiver-assisted usage;
• Able to communicate in Cantonese and to provide informed consent.

Критерии исключения

• Having severe problems in hearing, verbal communication, or vision;
• Engaged in ongoing psychotherapy or any other physiotherapy/ exercise/ relaxation interventions;
• Physically active for more than 150 minutes moderate-intensity exercise per week;
• Diagnosis of mental disorders or substance misuse;
• With severe cognitive impairment (Hong Kong Montreal Cognitive Assessment (HK-MoCA) score ≤ 18.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• School of Nursing, The Hong Kong Polytechnic University — Гонконг

Публикации

• Hu Y, Li Y, Tao R, Hsu CL, Craig A, Lam CY, Kahraman T, Leung AYM. Effects and mechanisms of a home-based action observation and motor imagery intervention on cognitive function and depression in spinal cord injury: a pilot randomized controlled trial protocol. Front Neurol. 2025 May 16;16:1578323. doi: 10.3389/fneur.2025.1578323. eCollection 2025. PMID 40452762

Идентификаторы

NCT: NCT06708026 · HSEARS20240716007-01 · P0051299

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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