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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Basic wheelchair exercises

    Behavioral

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

  • Watch landscape videos

    Behavioral

    A set of landscape videos

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Recruitment rate

The recruitment rate refers to the percentage of participants who give consent after determining their eligibility.

Time frame
Pre-intervention
2

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.

Time frame
1-month follow-up
3

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.

Time frame
1-month follow-up
4

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.

Time frame
During the intervention

Secondary outcomes

1

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.

Time frame
Baseline, immediately after intervention (an average of two months), and 1-month follow-up
2

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.

Time frame
Baseline, immediately after intervention (an average of two months), and 1-month follow-up
3

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.

Time frame
Baseline, immediately after intervention (an average of two months), and 1-month follow-up
4

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.

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

Other outcomes

Sponsors and contacts

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