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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Passive observing group | Active Comparator | Participants in the passive observing group will look at 10 different walking videos. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual walking | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Chronic pain will be assessed at pre-intervention and 1 week post-intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Nursing, The Hong Kong Polytechnic University | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14044222 | Background | 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. | |
| 35584970 | Background | 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. |
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| Passive observing walking | Behavioral | Participants in the control group will be given 10 different walking videos in total, one for each day, each approximately 15 minutes in length. |
|
| 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. |
| Chronic pain will be measured at pre-intervention and 1 week post-intervention. |
| 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. | Depression will be measured at pre-intervention and 1 week post-intervention. |
| 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. | Sleep quality will be assessed at pre-intervention and 1 week post-intervention. |
| 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. | The Igroup presence questionnaire will be assessed pre-test and 1 week post-intervention |
| 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. | Self-efficacy for exercise scale will be assessed pre-test and 1 week post-intervention |
| 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. | Quality of life will be assessed at pre-intervention and 1 week post-intervention. |
| 21479777 | Background | 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. |
| 12966256 | Background | 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. |
| 2748771 | Background | 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. |
| 18590603 | Background | 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. |
| 21129743 | Background | 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. |
| 32515813 | Background | 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. |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D011051 | Poliomyelitis |
| D003863 | Depression |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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