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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Motor Imagery; Spinal Cord Injuries (SCI); Cognitive Functions
• Intervention / Treatment: Behavioral: Action Observation and Motor Imagery (AOMI) training; Behavioral: Basic wheelchair exercises; Behavioral: Watch landscape videos

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 Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yule Hu, PhD candicate; Phone Number: 852-3400-2575; Email: huyulele.hu@connect.polyu.hk
• Study Contact Backup: Name: Yan Li, PhD; Phone Number: (852) 2766 6388; Email: yan-nursing.li@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • School of Nursing, The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global cognitive function	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.	Baseline, immediately after intervention (an average of two months), and 1-month follow-up
Depression	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.	Baseline, immediately after intervention (an average of two months), and 1-month follow-up
Recruitment rate	The recruitment rate refers to the percentage of participants who give consent after determining their eligibility.	Pre-intervention
Retention rate	The retention rate will be determined by dividing the number of individuals who finish the research by the total number of participants who consent.	1-month follow-up
Dropout rate	The dropout rate will be determined by the number of individuals who withdraw post-randomization divided by the total number of participants who consented.	1-month follow-up
Adherence rate	The adherence rate refers to the percentage of participants completing a minimum of 60% of interventions, equivalent to at least 15 sessions.	Immediately after intervention (an average of two months)
Number of participants with adverse events	The count of participants who reported at least one adverse event related to the intervention, including severe dizziness, fatigue, and pain.	During the intervention
Intervention satisfaction	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.	Immediately after intervention (an average of two months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Digit Span Test [Forward Span]	The Digit Span Test [Forward Span] will be used to assess attention, concentration, and short-term memory. The examiner will pronounce a list of digits at a rate of approximately one digit per second, and subjects are required to immediately repeat the list in the same order. The Digit Span Test scores range from 0 to 9. The higher scores mean a better outcome.	Baseline, immediately after intervention (an average of two months), and 1-month follow-up
The Stroop Color Word Test	The Stroop Color Word Test will be used to measure executive function and attention. It will be determined by subtracting the Color (congruent trials) from the Color-Word (incongruent trials) scores. It is a measure of response competition and interference. Scoring is based on the time it takes to read (complete) incongruent trials relative to congruent trials. A negative mean value reflects an improvement in performance after the intervention. A positive mean value reflects a decrease in performance after the intervention.	Baseline, immediately after intervention (an average of two months), and 1-month follow-up
The oral version of the Symbol Digit Modalities Test	This test will be used to assess cognitive processing speed. The participant will be given 90 seconds to verbally match symbols with digits as quickly as possible. The correct verbal responses will be recorded. A larger number of correct answers given within the time limit represents better switching attention and information-processing speeds in an individual.	Baseline, immediately after intervention (an average of two months), and 1-month follow-up
The Digit Span Tests [Backward Span]	The backward digit span task measures visuospatial integration and working memory; hence, the backward digit span task is a more appropriate measure for executive function. The backward digit span task uses the same procedure as the Digit span forward task, except that in this case, subjects have to reproduce the sequence of digits in reverse order, and the longest list consists of nine items. The Digit Span Test scores range from 0 to 9.	Baseline, immediately after intervention (an average of two months), and 1-month follow-up
Change in gray matter cortical thickness	Change in mean cortical thickness obtained from T1-weighted structural images. A positive mean value reflects an increase in cortical thickness post-intervention, and a negative mean value reflects a decrease in cortical thickness post-intervention.	Baseline, immediately after intervention (an average of two months)
Change in white matter integrity	Change in white matter integrity obtained from diffusion-weighted imaging. Increased white matter integrity is associated with improved cognitive performance, whereas decreased white matter integrity is associated with decreased cognitive performance.	Baseline, immediately after intervention (an average of two months)
Change in white matter hyperintensities	Change in white matter hyperintensities obtained from Fluid-Attenuated Inversion Recovery imaging. Increased white matter hyperintensities may be indicative of unfavorable outcomes.	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	Change in blood-oxygen-level-dependent (BOLD) signal (neuroplasticity) during performing mental imagination of the action while watching the video will be measured using task-based functional magnetic resonance imaging (fMRI). The mean values reported are changes in factor scores that reflect the overall change in the BOLD signal pre- to post-intervention. Positive values reflect an increase in BOLD signal post-intervention, whereas negative mean values reflect a decrease in BOLD signal post-intervention. There are no minimum or maximum values, ranges, or thresholds associated with the BOLD measure.	Baseline, immediately after intervention (an average of two months)
Change in functional connectivity features or neural networks	Change in functional connectivity features or neural networks will be measured using resting-stated fMRI.	Baseline, immediately after intervention (an average of two months)
Pain	The Chinese version of the Brief Pain Inventory (BPI-C) will be used to assess the pain severity and interference. The total scores for pain severity (4 items) and interference (7 items) are measured with a 11-point scale (from 0 = no pain/interference to 10 = worst pain/interference imaginable), where higher scores represent more violent pain.	Baseline, immediately after intervention (an average of two months), and 1-month follow-up
Self-efficacy for exercise	The 9-item Chinese version of the self-efficacy for exercise will be used to evaluate participants' confidence level (from 0 not confident to 10 very confident) regarding engaging in regular exercise.	Baseline, immediately after intervention (an average of two months), and 1-month follow-up
Motor imagery ability	The short version of the Kinesthetic and Visual Imagery Questionnaire (the KVIQ-10) will be used to evaluate the participants' motor imagery ability.	Baseline, immediately after intervention (an average of two months), and 1-month follow-up

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 24, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Wounds and Injuries; Behavioral Symptoms; Mood Disorders; Trauma, Nervous System; Spinal Cord Diseases; Depression; Depressive Disorder; Spinal Cord Injuries
• Other Study ID Numbers: HSEARS20240716007-01; P0051299 (Other Grant/Funding Number: The Hong Kong Polytechnic University Fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No