Spinal Cord Injuries (SCI)NCT06708026
Evaluation of a Home-based AOMI Intervention on Cognitive Function and Depression Among Adults With SCI
A study testing Action Observation and Motor Imagery (AOMI) training, Basic wheelchair exercises and Watch landscape videos in people with Spinal Cord Injuries (SCI) and Depression, run by The Hong Kong Polytechnic University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries (SCI), Depression, Motor Imagery
- What is being tested?
- Action Observation and Motor Imagery (AOMI) training, Basic wheelchair exercises and Watch landscape videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
School of Nursing, The Hong Kong Polytechnic University
Hong Kong, 999077
About this study
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
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.
Read the 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.
- Being tested
- Action Observation and Motor Imagery (AOMI) training, Basic wheelchair exercises, Watch landscape videos
- Medical subject headings
- Spinal Cord Injuries, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation and Motor Imagery (AOMI) trainingBehavioural
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.
Basic wheelchair exercisesBehavioural
A set of low-intensity warm-up wheelchair exercises developed specifically for survivors with spinal cord injury
Watch landscape videosBehavioural
A set of landscape videos
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Basic wheelchair exercises; Behavioral: Watch landscape videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The recruitment rate refers to the percentage of participants who give consent after determining their eligibility.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, immediately after intervention (an average of two months)
Pain severity and interference
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.
Measured: 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.
Measured: 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.
Measured: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Jan 2025
- Primary completion30 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708026
- Sponsor's protocol ID
- HSEARS20240716007-01
- Other IDs
- P0051299
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40452762
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06708026
- Acronym / sponsor ID
- HSEARS20240716007-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Action Observation and Motor Imagery (AOMI) training, Behavioral: Basic wheelchair exercisesFor 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. |
| Control group | Active comparator | Behavioral: Basic wheelchair exercises, Behavioral: Watch landscape videosFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Observation and Motor Imagery (AOMI) trainingParticipants 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. | Behavioural | Intervention group |
| Basic wheelchair exercisesA set of low-intensity warm-up wheelchair exercises developed specifically for survivors with spinal cord injury | Behavioural | Control group, Intervention group |
| Watch landscape videosA set of landscape videos | Behavioural | Control group |
Primary outcome
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.
12 secondary outcomes
The Digit Span Test [Forward Span]
Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
The Digit Span Tests [Backward Span]
Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
The Stroop Color Word Test
Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
The oral version of the Symbol Digit Modalities Test
Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
Change in gray matter cortical thickness
Time frame: Baseline, immediately after intervention (an average of two months)
Change in white matter integrity
Time frame: Baseline, immediately after intervention (an average of two months)
Change in white matter hyperintensities
Time frame: 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
Time frame: Baseline, immediately after intervention (an average of two months)
Change in functional connectivity features or neural networks
Time frame: Baseline, immediately after intervention (an average of two months)
Pain severity and interference
Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
Self-efficacy for exercise
Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
Motor imagery ability
Time frame: Baseline, immediately after intervention (an average of two months), and 1-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 40452762Hu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation and Motor Imagery (AOMI) training, Basic wheelchair exercises and Watch landscape videos in people with Spinal Cord Injuries (SCI) and Depression, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Pre-intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06708026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.