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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 46
- Locations
- 2
- Primary Endpoint
- Recruitment rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Action Observation and Motor Imagery (AOMI) training (Behavioral)
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.
Intervention: Basic wheelchair exercises (Behavioral)
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.
Intervention: Basic wheelchair exercises (Behavioral)
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.
Intervention: Watch landscape videos (Behavioral)
Outcomes
Primary Outcomes
Recruitment rate
Time Frame: Pre-intervention
The recruitment rate refers to the percentage of participants who give consent after determining their eligibility.
Retention rate
Time Frame: 1-month follow-up
The retention rate will be determined by dividing the number of individuals who finish the research by the total number of participants who consent.
Dropout rate
Time Frame: 1-month follow-up
The dropout rate will be determined by the number of individuals who withdraw post-randomization divided by the total number of participants who consented.
Number of participants with adverse events
Time Frame: During the intervention
The count of participants who reported at least one adverse event related to the intervention, including severe dizziness, fatigue, and pain.
Intervention satisfaction
Time Frame: Immediately after intervention (an average of two months)
The intervention satisfaction will be assessed using an 8-item Client Satisfaction Questionnaire employing a four-point Likert scale, alongside one-on-one qualitative interviews. The total possible score on the 8-item Client Satisfaction Questionnaire ranges from 8 to 32, with higher scores indicating greater levels of satisfaction.
Adherence rate
Time Frame: Immediately after intervention (an average of two months)
The adherence rate refers to the percentage of participants completing a minimum of 60% of interventions, equivalent to at least 15 sessions.
Global cognitive function
Time Frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
The Chinese version of Neuropsychiatry Unit Cognitive Assessment Tool (NUCOG) will be used. This tool comprises 21 items in 5 cognitive domains: attention, visuoconstructional, memory, executive, and language. Scores for each of the domains range between 0 and 20, adding up to a total NUCOG score out of 100. Higher scores indicate higher levels of cognitive function.
Depression
Time Frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
The level of depression will be assessed by version 2 of the Beck Depression Inventory (BDI-II), which consists of 21 items assessing 2 factors (cognitive and affective, and somatic symptoms). The total possible score of BDI-II is 0 to 63; higher scores reflect higher levels of depression.
Secondary Outcomes
- The Digit Span Tests [Backward Span](Baseline, immediately after intervention (an average of two months), and 1-month follow-up)
- The Stroop Color Word Test(Baseline, immediately after intervention (an average of two months), and 1-month follow-up)
- The oral version of the Symbol Digit Modalities Test(Baseline, immediately after intervention (an average of two months), and 1-month follow-up)
- Change in gray matter cortical thickness(Baseline, immediately after intervention (an average of two months))
- Change in white matter integrity(Baseline, immediately after intervention (an average of two months))
- Change in white matter hyperintensities(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(Baseline, immediately after intervention (an average of two months))
- Change in functional connectivity features or neural networks(Baseline, immediately after intervention (an average of two months))
- Pain(Baseline, immediately after intervention (an average of two months), and 1-month follow-up)
- Self-efficacy for exercise(Baseline, immediately after intervention (an average of two months), and 1-month follow-up)
- Motor imagery ability(Baseline, immediately after intervention (an average of two months), and 1-month follow-up)
- The Digit Span Test [Forward Span](Baseline, immediately after intervention (an average of two months), and 1-month follow-up)
- Pain severity and interference(Baseline, immediately after intervention (an average of two months), and 1-month follow-up)