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Not yet recruiting NCT06708026

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

No phase Interventional Spinal Cord Injuries (SCI) Depression Motor Imagery Cognitive Functions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Action Observation and Motor Imagery (AOMI) training, Basic wheelchair exercises, Watch landscape videos.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries (SCI), Depression, Motor Imagery, Cognitive Functions. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral 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.
  • Behavioral Basic wheelchair exercises
    A set of low-intensity warm-up wheelchair exercises developed specifically for survivors with spinal cord injury
  • Behavioral Watch landscape videos
    A set of landscape videos

Primary outcome measures

  • Recruitment rate [Time frame: Pre-intervention]
  • Retention rate [Time frame: 1-month follow-up]
  • Dropout rate [Time frame: 1-month follow-up]
  • Number of participants with adverse events [Time frame: During the intervention]
  • Intervention satisfaction [Time frame: Immediately after intervention (an average of two months)]
  • Adherence rate [Time frame: Immediately after intervention (an average of two months)]
  • Global cognitive function [Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]
  • Depression [Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]
Secondary outcome measures (12)
  • The Digit Span Test [Forward Span] [Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]
  • The Digit Span Tests [Backward Span] [Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]
  • The Stroop Color Word Test [Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]
  • The oral version of the Symbol Digit Modalities Test [Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]
  • Change in gray matter cortical thickness [Time frame: Baseline, immediately after intervention (an average of two months)]
  • Change in white matter integrity [Time frame: Baseline, immediately after intervention (an average of two months)]
  • Change in white matter hyperintensities [Time frame: 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 [Time frame: Baseline, immediately after intervention (an average of two months)]
  • Change in functional connectivity features or neural networks [Time frame: Baseline, immediately after intervention (an average of two months)]
  • Pain [Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]
  • Self-efficacy for exercise [Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]
  • Motor imagery ability [Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • School of Nursing, The Hong Kong Polytechnic University — Hong Kong

Publications

  • 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

Identifiers

NCT: NCT06708026 · HSEARS20240716007-01 · P0051299

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗