Evaluation of a Home-based AOMI Intervention on Cognitive Function and Depression Among Adults With SCI
NCT06708026, Not applicable, Completed, The Hong Kong Polytechnic University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evaluation of a Home-based AOMI Intervention on Cognitive Function and Depression Among Adults With SCI | ClinicalTrials.gov |
| NCT number | NCT06708026 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 46 participants, actual | ClinicalTrials.gov |
| Lead sponsor | The Hong Kong Polytechnic University | ClinicalTrials.gov |
| Conditions | Spinal Cord Injuries (SCI), Depression, Motor Imagery, Cognitive Functions | ClinicalTrials.gov |
| Interventions | Action Observation and Motor Imagery (AOMI) training, Basic wheelchair exercises, Watch landscape videos | ClinicalTrials.gov |
| First posted | 2024-11-27 | ClinicalTrials.gov |
| Last updated | 2026-09-17 | ClinicalTrials.gov |
Registered outcomes 20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Recruitment rate | Pre-intervention | The recruitment rate refers to the percentage of participants who give consent after determining their eligibility. | ClinicalTrials.gov |
| Primary | Retention rate | 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. | ClinicalTrials.gov |
| Primary | Dropout rate | 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. | ClinicalTrials.gov |
| Primary | Number of participants with adverse events | During the intervention | The count of participants who reported at least one adverse event related to the intervention, including severe dizziness, fatigue, and pain. | ClinicalTrials.gov |
| Primary | Intervention satisfaction | 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. | ClinicalTrials.gov |
| Primary | Adherence rate | 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. | ClinicalTrials.gov |
| Primary | Global cognitive function | 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. | ClinicalTrials.gov |
| Primary | Depression | 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. | ClinicalTrials.gov |
| Secondary | The Digit Span Test [Forward Span] | Baseline, immediately after intervention (an average of two months), and 1-month follow-up | 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. | ClinicalTrials.gov |
| Secondary | The Digit Span Tests [Backward Span] | Baseline, immediately after intervention (an average of two months), and 1-month follow-up | 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. | ClinicalTrials.gov |
| Secondary | The Stroop Color Word Test | Baseline, immediately after intervention (an average of two months), and 1-month follow-up | 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. | ClinicalTrials.gov |
| Secondary | The oral version of the Symbol Digit Modalities Test | Baseline, immediately after intervention (an average of two months), and 1-month follow-up | 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. | ClinicalTrials.gov |
| Secondary | Change in gray matter cortical thickness | Baseline, immediately after intervention (an average of two months) | 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. | ClinicalTrials.gov |
| Secondary | Change in white matter integrity | Baseline, immediately after intervention (an average of two months) | 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. | ClinicalTrials.gov |
| Secondary | Change in white matter hyperintensities | Baseline, immediately after intervention (an average of two months) | Change in white matter hyperintensities obtained from Fluid-Attenuated Inversion Recovery imaging. Increased white matter hyperintensities may be indicative of unfavorable outcomes. | ClinicalTrials.gov |
| Secondary | 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 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. | ClinicalTrials.gov |
| Secondary | Change in functional connectivity features or neural networks | Baseline, immediately after intervention (an average of two months) | Change in functional connectivity features or neural networks will be measured using resting-stated fMRI. | ClinicalTrials.gov |
| Secondary | Pain severity and interference | Baseline, immediately after intervention (an average of two months), and 1-month follow-up | 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. | ClinicalTrials.gov |
| Secondary | Self-efficacy for exercise | Baseline, immediately after intervention (an average of two months), and 1-month follow-up | 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. | ClinicalTrials.gov |
| Secondary | Motor imagery ability | Baseline, immediately after intervention (an average of two months), and 1-month follow-up | The short version of the Kinesthetic and Visual Imagery Questionnaire (the KVIQ-10) will be used to evaluate the participants' motor imagery ability. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 40452762 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)