ClinicalTrials.gg
CompletedNCT07073144Updated May 19, 2026

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

An interventional study of Virtual walking and Passive observing walking in Severe Mobility Impairment, Spinal Cord Injuries (Complete and Incomplete) and Poliomyelitis, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • severe mobility impairment
  • virtual reality
  • depression
  • quality of life
03

In context

Spinal Cord Injuries

2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.

This study's enrollment of 24 is close to the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Inability to walk 4 meters in less than 10 seconds without walking aids, or self-, proxy-, or medical-record-reported inability to walk independently across a small room (≈ 4 m), or dependence on a walking aid for more than 6 months
  • Minimum 6 months post-injury or disease onset
  • Able to communicate in Cantonese

Exclusion criteria

Exclusion Criteria:

  • Have severe cognitive impairment (a score \< 6 on the Abbreviated Mental Test)
  • Have severe mental illness (i.e., schizophrenia and major depression)
  • Have acute medical illness or exacerbation requiring hospital or intensive treatment; planned major surgery or inpatient rehabilitation during the study period
  • Currently engage in similar interventions
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Virtual walking group

    Participants in the virtual walking group will use arm swing locomotion to experience virtual walking in 10 "Digital Strolling" scenarios, mainly in a variety of natural environments.

    Behavioral: Virtual walking

  • Active comparator
    Passive observing group

    Participants in the passive observing group will look at 10 different walking videos.

    Behavioral: Passive observing walking

Interventions

  • BehavioralVirtual walking

    Participants in the intervention group will wear a head-mounted display and hold a controller to swing their arm and control the virtual avatar walking in the virtual world. The intervention will include 10 scenarios of virtual walking intervention (1 scenario daily, each lasting for 15-20 minutes).

  • BehavioralPassive observing walking

    Participants in the control group will be given 10 different walking videos in total, one for each day, each approximately 15 minutes in length.

06

What researchers measure

Primary outcomes

  1. Feasibility: Time taken to recruit the sample

    The total time taken to recruit the target sample size.

    Time frame: The outcome will be assessed through study completion, which is expected to be an average of 6 months.

  2. Feasibility: Recruitment rate

    The percentage of eligible participants who provide informed consent.

    Time frame: The outcome will be assessed through study completion, which is expected to be an average of 6 months.

  3. Feasibility: Drop-out rate

    The percentage of randomised participants who withdrew post-randomization

    Time frame: The outcome will be assessed through study completion, which is expected to be an average of 6 months.

  4. Acceptability: Adherence rate

    Number of participants who completed the intervention modules as defined by the protocol.

    Time frame: This outcome will be measured at the end of the 10-day intervention period.

  5. Intervention satisfaction

    Participant satisfaction will be explored via semi-structured one-to-one interviews to identify barriers and facilitators.

    Time frame: The outcome will be assessed 1 week post-intervention.

  6. Adverse event

    Number of participants experiencing at least one adverse event

    Time frame: The outcome will be assessed through study completion, which is expected to be an average of 6 months.

Secondary outcomes

  1. Chronic pain

    Chronic pain will be measured using the Numerical Pain Rating Scale (NPRS), with higher score indicate higher pain level, 0 is none pain, 1-3 means mild pain, 4-6 meanes moderate pain, 7-9 means severe pain, 10 is severe and worst pain.

    Time frame: Chronic pain will be assessed at pre-intervention and 1 week post-intervention.

  2. Chronic pain

    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.

    Time frame: Chronic pain will be measured at pre-intervention and 1 week post-intervention.

  3. Depression

    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.

    Time frame: Depression will be measured at pre-intervention and 1 week post-intervention.

  4. Sleep quality

    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.

    Time frame: Sleep quality will be assessed at pre-intervention and 1 week post-intervention.

  5. VR experience

    VR experience 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.

    Time frame: The Igroup presence questionnaire will be assessed pre-test and 1 week post-intervention

  6. Self-efficacy for exercise

    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.

    Time frame: Self-efficacy for exercise scale will be assessed pre-test and 1 week post-intervention

  7. Quality of life (The 5-level EuroQol of Life -5 dimensions)

    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.

    Time frame: Quality of life will be assessed at pre-intervention and 1 week post-intervention.

07

Study locations

1 site
  • School of Nursing, The Hong Kong Polytechnic University
    Hong Kong, Hong Kong
08

References and documents

Publications

  • KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available. PubMed 14044222 ↗
  • Shih YC, Chou CC, Lu YJ, Yu HY. Reliability and validity of the traditional Chinese version of the GAD-7 in Taiwanese patients with epilepsy. J Formos Med Assoc. 2022 Nov;121(11):2324-2330. doi: 10.1016/j.jfma.2022.04.018. Epub 2022 May 16. PubMed 35584970 ↗
  • Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9. PubMed 21479777 ↗
  • Krause SJ, Backonja MM. Development of a neuropathic pain questionnaire. Clin J Pain. 2003 Sep-Oct;19(5):306-14. doi: 10.1097/00002508-200309000-00004. PubMed 12966256 ↗
  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. PubMed 2748771 ↗
  • Leung GT, de Jong Gierveld J, Lam LC. Validation of the Chinese translation of the 6-item De Jong Gierveld Loneliness Scale in elderly Chinese. Int Psychogeriatr. 2008 Dec;20(6):1262-72. doi: 10.1017/S1041610208007552. Epub 2008 Jul 1. PubMed 18590603 ↗
  • Lee LL, Chiu YY, Ho CC, Wu SC, Watson R. The Chinese version of the Outcome Expectations for Exercise scale: validation study. Int J Nurs Stud. 2011 Jun;48(6):672-80. doi: 10.1016/j.ijnurstu.2010.11.001. Epub 2010 Dec 3. PubMed 21129743 ↗
  • Levis B, Sun Y, He C, Wu Y, Krishnan A, Bhandari PM, Neupane D, Imran M, Brehaut E, Negeri Z, Fischer FH, Benedetti A, Thombs BD; Depression Screening Data (DEPRESSD) PHQ Collaboration; Che L, Levis A, Riehm K, Saadat N, Azar M, Rice D, Boruff J, Kloda L, Cuijpers P, Gilbody S, Ioannidis J, McMillan D, Patten S, Shrier I, Ziegelstein R, Moore A, Akena D, Amtmann D, Arroll B, Ayalon L, Baradaran H, Beraldi A, Bernstein C, Bhana A, Bombardier C, Buji RI, Butterworth P, Carter G, Chagas M, Chan J, Chan LF, Chibanda D, Cholera R, Clover K, Conway A, Conwell Y, Daray F, de Man-van Ginkel J, Delgadillo J, Diez-Quevedo C, Fann J, Field S, Fisher J, Fung D, Garman E, Gelaye B, Gholizadeh L, Gibson L, Goodyear-Smith F, Green E, Greeno C, Hall B, Hampel P, Hantsoo L, Haroz E, Harter M, Hegerl U, Hides L, Hobfoll S, Honikman S, Hudson M, Hyphantis T, Inagaki M, Ismail K, Jeon HJ, Jette N, Khamseh M, Kiely K, Kohler S, Kohrt B, Kwan Y, Lamers F, Asuncion Lara M, Levin-Aspenson H, Lino V, Liu SI, Lotrakul M, Loureiro S, Lowe B, Luitel N, Lund C, Marrie RA, Marsh L, Marx B, McGuire A, Mohd Sidik S, Munhoz T, Muramatsu K, Nakku J, Navarrete L, Osorio F, Patel V, Pence B, Persoons P, Petersen I, Picardi A, Pugh S, Quinn T, Rancans E, Rathod S, Reuter K, Roch S, Rooney A, Rowe H, Santos I, Schram M, Shaaban J, Shinn E, Sidebottom A, Simning A, Spangenberg L, Stafford L, Sung S, Suzuki K, Swartz R, Tan PLL, Taylor-Rowan M, Tran T, Turner A, van der Feltz-Cornelis C, van Heyningen T, van Weert H, Wagner L, Li Wang J, White J, Winkley K, Wynter K, Yamada M, Zhi Zeng Q, Zhang Y. Accuracy of the PHQ-2 Alone and in Combination With the PHQ-9 for Screening to Detect Major Depression: Systematic Review and Meta-analysis. JAMA. 2020 Jun 9;323(22):2290-2300. doi: 10.1001/jama.2020.6504. PubMed 32515813 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2025 to primary completion in Oct 2025, 5 months.

Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's 5 months is below that.

Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2025
First posted
Jul 18, 2025
StartActual
May 9, 2025
Primary completionActual
Oct 15, 2025
CompletionActual
Oct 30, 2025
Last update
May 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07073144
Responsible party
Sponsor
First posted
Jul 18, 2025
Start date
May 9, 2025
Primary completion
Oct 15, 2025
Completion
Oct 30, 2025
Last update
May 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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