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

T

The Hong Kong Polytechnic University

Status

Not yet enrolling

Conditions

Spinal Cord Injuries (SCI)
Cognitive Functions
Depression
Motor Imagery

Treatments

Behavioral: Watch landscape videos
Behavioral: Basic wheelchair exercises
Behavioral: Action Observation and Motor Imagery (AOMI) training

Study type

Interventional

Funder types

Other

Identifiers

NCT06708026
HSEARS20240716007-01
P0051299 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

46 participants in 2 patient groups

Intervention group
Experimental group
Description:
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.
Treatment:
Behavioral: Action Observation and Motor Imagery (AOMI) training
Behavioral: Basic wheelchair exercises
Control group
Active Comparator group
Description:
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.
Treatment:
Behavioral: Basic wheelchair exercises
Behavioral: Watch landscape videos

Trial contacts and locations

1

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Central trial contact

Yule Hu, PhD candicate; Yan Li, PhD

Data sourced from clinicaltrials.gov

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