The Impact of 'Digital Strolling' on Depression and Quality of Life of People With Severe Mobility Impairment

Not Applicable

Recruiting

• Conditions: Severe Mobility Impairment; Spinal Cord Injuries (Complete and Incomplete); Poliomyelitis

• Registration Number: NCT07073144
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

This intervention aims to develop and test the feasibility, acceptability, and preliminary effects of a "Digital Strolling" intervention among people with SMI. The intervention group will receive a "Digital Strolling" intervention, which consists of 20 minutes "Digital strolling" for 10 days, with lessons occurring once a day. The control group will receive passive observation of virtual walking videos only.

Detailed Description

This study is a two-arm, pilot randomized controlled trial, which will be used to evaluate and compare the effects of the "Digital strolling" intervention and the passive observing control group.

Twenty-four participants will be recruited from the Hong Kong Polytechnic University. Participants will be assigned to the "Digital Strolling" or control group. Participants in the "Digital Strolling" group will receive an arm swing virtual walking intervention, which consists of 20 minutes of virtual walking for 10 days and is conducted at home. Qualitative interviews with the "Digital Strolling" group will be conducted to understand their acceptability, usability, perceived strengths, and limitations of the intervention. While the one in the control group will receive 10 passive observing walking videos for 10 days.

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-09
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Primary Completion: 2025-09
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Have SMI (people who are inability to walk or climb stairs, stand, or use a wheelchair or scooter by self-report (inability to perform walking or climbing stairs or standing, or use of a wheelchair or scooter) over 6 months
• Have mild to moderate levels of depression
• Able to communicate in Cantonese
• Provide informed consent.

Exclusion Criteria

• Have severe cognitive impairment
• Have an episode of severe mental illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression	Depression will be measured at pre-intervention and 1 week post-intervention.	Depression will be measured by the 2-item Patient Health Questionnaire and the 9-item Patient Health Questionnaire. The PHQ-2 has two items (depressed mood and anhedonia), with range from 0-6. Highest score represents higher level of depression symptom severity. The PHQ-9 has 9 items (range, 0-27), higher score also means higher level of depression, the severity score ranges are as follows: 0-4 no depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression.

Secondary Outcome Measures

Name	Time	Method
Chronic pain	Chronic pain will be measured at pre-intervention and 1 week post-intervention.	The chronic pain will also be measured using Brief Pain Inventory (BPI). This scale has two domains: pain severity and pain interference. Mean scores of item 3-6 and 9A-9G reflecting pain severity and pain interference respectively, higher scores indicating higher pain severity or pain interference.
Activity of Daily Living	Activity of Daily Living will be assessed at pre-test and 1 week post-intervention	Activity of daily living will be measured using the Barthel index, which measures the performance of ten basic activities of daily life (ADL) such as dressing, mobility, and grooming. The total score of this scale ranges from 0-100, 0-20 indicate complete dependence; 21-60 points means severe dependence, 61-90 indicate moderate dependence; 91-99 means mild dependence, 100 points mean complete independence.
Sleep quality	Sleep quality will be assessed at pre-intervention and 1 week post-intervention.	Sleep quality will be measured using the Pittsburgh Sleep Quality Index. The total score of the scale ranges from 0 to 21; a higher score indicates lower sleep quality.
Quality of life (The 5-level EuroQol of Life -5 dimensions)	Quality of life will be assessed at pre-intervention and 1 week post-intervention.	Quality of life will be measured using the 5-level EuroQol of Life -5 dimensions. This scale scores ranged from -0.59 to 1, where 1 is the best possible health state.
Anxiety	Anxiety will be assessed pre-intervention and 1 week post intervention	Anxiety will be measured using the Generalized Anxiety Disorder-7. This scale has 7 items, with a total score ranging from 0-21. 1-4 indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates moderate to severe anxiety.
Virtual presence	Igroup presence questionnaire will be assessed pre-test and 1 week post intervention	Classifying virtual presence will be assessed using the Igroup presence questionnaire. The questionnaire has three subscales (Spatial presence, involvement, and experienced realism). The questionnaire needs to calculate the average scores across the subscales, then compute an overall sense of presence by averaging these subscale means. Higher subscale means higher spatial presence, involvement, and experienced realism. The higher total scores mean a higher overall sense of presence.
Self-efficacy for exercise	Self-efficacy for exercise scale will be assessed pre-test and 1 week post-intervention	Self-efficacy for exercise scale will be measured using the Chinese self-efficacy for exercise scale. The total score of this scale ranges from 0 to 90; a higher score represents strong exercise self-efficacy.
Loneliness	Loneliness will be assessed pre-test and 1 week post-intervention	Loneliness will be measured using the Chinese version of the 6-item De Jong Gierveld Loneliness Scale. This scale has two subscales (emotional loneliness and social loneliness). The scores range from 0 to 6, where 0 means no loneliness and 6 indicates severe loneliness.

Trial Locations

Locations (1)

School of Nursing, The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong