NCT07073144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

February 23, 2026

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

June 5, 2025

Last Update Submit

February 19, 2026

Conditions

Keywords

severe mobility impairmentvirtual realitydepressionquality of life

Outcome Measures

Primary Outcomes (6)

  • Feasibility: Time taken to recruit the sample

    The total time taken to recruit the target sample size.

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

  • Feasibility: Recruitment rate

    The percentage of eligible participants who provide informed consent.

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

  • Feasibility: Drop-out rate

    The percentage of randomised participants who withdrew post-randomization

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

  • Acceptability: Adherence rate

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

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

  • Intervention satisfaction

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

    The outcome will be assessed 1 week post-intervention.

  • Adverse event

    Number of participants experiencing at least one adverse event

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

Secondary Outcomes (7)

  • Chronic pain

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

  • Chronic pain

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

  • Depression

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

  • Sleep quality

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

  • Virtual presence

    Igroup presence questionnaire will be assessed pre-test and 1 week post intervention

  • +2 more secondary outcomes

Study Arms (2)

Virtual walking group

EXPERIMENTAL

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

Passive observing group

ACTIVE COMPARATOR

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

Behavioral: Passive observing walking

Interventions

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

Passive observing group
Virtual walkingBEHAVIORAL

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).

Virtual walking group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (8)

  • 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.

    PMID: 14044222BACKGROUND
  • 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.

    PMID: 35584970BACKGROUND
  • 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.

    PMID: 21479777BACKGROUND
  • 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.

    PMID: 12966256BACKGROUND
  • 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.

    PMID: 2748771BACKGROUND
  • 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.

    PMID: 18590603BACKGROUND
  • 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.

    PMID: 21129743BACKGROUND
  • 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.

    PMID: 32515813BACKGROUND

MeSH Terms

Conditions

Spinal Cord InjuriesPoliomyelitisDepression

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesMyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2025

First Posted

July 18, 2025

Study Start

May 9, 2025

Primary Completion

October 15, 2025

Study Completion

October 30, 2025

Last Updated

February 23, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations