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

NCT ID: NCT06708026

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injuries (SCI) Depression Motor Imagery Cognitive Functions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

We aim to have two study groups. Forty-six participants will be randomly assigned to either the intervention group, which will receive an 8-week AOMI intervention combined with basic wheelchair exercises, or the control group, which will watch landscape videos and perform basic wheelchair exercises. The intervention duration, number of sessions, and frequency of the control group are the same as the intervention group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Participants and the researcher who will enroll in the intervention process and conduct the qualitative interview will not be blinded. The data analyst and the baseline and outcome assessor will be blinded from the group assignment.

Study Groups

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Intervention group

For each session, participants will be required to conduct a ten-minute basic wheelchair exercise followed by a twenty-minute AOMI training at home. The whole intervention will last for eight weeks, three times a week.

Group Type EXPERIMENTAL

Action Observation and Motor Imagery (AOMI) training

Intervention Type BEHAVIORAL

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.

Basic wheelchair exercises

Intervention Type BEHAVIORAL

A set of low-intensity warm-up wheelchair exercises developed specifically for survivors with spinal cord injury

Control group

For each session, participants will be required to conduct a ten-minute basic wheelchair exercise, followed by 20 minutes of watching landscape videos in their homes. The whole intervention will last for eight weeks, three times a week.

Group Type ACTIVE_COMPARATOR

Basic wheelchair exercises

Intervention Type BEHAVIORAL

A set of low-intensity warm-up wheelchair exercises developed specifically for survivors with spinal cord injury

Watch landscape videos

Intervention Type BEHAVIORAL

A set of landscape videos

Interventions

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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.

Intervention Type BEHAVIORAL

Basic wheelchair exercises

A set of low-intensity warm-up wheelchair exercises developed specifically for survivors with spinal cord injury

Intervention Type BEHAVIORAL

Watch landscape videos

A set of landscape videos

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong, Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Yule Hu, PhD candicate

Role: CONTACT

852-3400-2575

Yan Li, PhD

Role: CONTACT

(852) 2766 6388

References

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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.

Reference Type DERIVED
PMID: 40452762 (View on PubMed)

Other Identifiers

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P0051299

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSEARS20240716007-01

Identifier Type: -

Identifier Source: org_study_id

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