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

NCT06708026 | Not Yet Recruiting

• 2 other identifiers: HSEARS20240716007-01P0051299
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries (SCI); Depression; Motor Imagery; Cognitive Functions

Outcome Measures

Primary Outcomes (8)

• 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

• 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)

• 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)

• 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

Secondary Outcomes (12)

• The Digit Span Test [Forward Span]

  Baseline, immediately after intervention (an average of two months), and 1-month follow-up

• 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)

Study Arms (2)

Intervention group

EXPERIMENTAL

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; Behavioral: Basic wheelchair exercises

Control group

ACTIVE COMPARATOR

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; Behavioral: Watch landscape videos

Interventions

Action Observation and Motor Imagery (AOMI) training 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.

Intervention group

Basic wheelchair exercises BEHAVIORAL

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

Control group; Intervention group

Watch landscape videos BEHAVIORAL

A set of landscape videos

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 40452762 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Depression

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior

Central Study Contacts

Yule Hu, PhD candicate

CONTACT

852-3400-2575; huyulele.hu@connect.polyu.hk

Yan Li, PhD

CONTACT

(852) 2766 6388; yan-nursing.li@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 27, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)