Clinical trial NCT06708026: Evaluation of a Home-based AOMI Intervention on Cognitive Function and Depression Among Adults with SCI
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries (SCI)
Depression
Motor Imagery
Cognitive Functions
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Recruitment rate
timeFrame: Pre-intervention
measure: Retention rate
timeFrame: 1-month follow-up
measure: Dropout rate
timeFrame: 1-month follow-up
measure: Number of participants with adverse events
timeFrame: During the intervention
measure: Intervention satisfaction
timeFrame: Immediately after intervention (an average of two months)
measure: Adherence rate
timeFrame: Immediately after intervention (an average of two months)
measure: Global cognitive function
timeFrame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
measure: Depression
timeFrame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
Secondary outcomes:
measure: The Digit Span Test [Forward Span]
timeFrame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
measure: The Digit Span Tests [Backward Span]
timeFrame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
measure: The Stroop Color Word Test
timeFrame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
measure: The oral version of the Symbol Digit Modalities Test
timeFrame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
measure: Change in gray matter cortical thickness
timeFrame: Baseline, immediately after intervention (an average of two months)
measure: Change in white matter integrity
timeFrame: Baseline, immediately after intervention (an average of two months)
measure: Change in white matter hyperintensities
timeFrame: Baseline, immediately after intervention (an average of two months)
measure: Change in Blood-oxygen-level-dependent (BOLD) signal during Action Observation and Motor Imagery task conditions
timeFrame: Baseline, immediately after intervention (an average of two months)
measure: Change in functional connectivity features or neural networks
timeFrame: Baseline, immediately after intervention (an average of two months)
measure: Pain
timeFrame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
measure: Self-efficacy for exercise
timeFrame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
measure: Motor imagery ability
timeFrame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The Hong Kong Polytechnic University
Study officials:
References: