Poliomyelitis, Severe Mobility Impairment, Spinal Cord Injuries (Complete and Incomplete)
Conditions
Keywords
severe mobility impairment, virtual reality, depression, quality of life
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.
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.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Time taken to recruit the sample | The outcome will be assessed through study completion, which is expected to be an average of 6 months. | The total time taken to recruit the target sample size. |
| Feasibility: Recruitment rate | The outcome will be assessed through study completion, which is expected to be an average of 6 months. | The percentage of eligible participants who provide informed consent. |
| Feasibility: Drop-out rate | The outcome will be assessed through study completion, which is expected to be an average of 6 months. | The percentage of randomised participants who withdrew post-randomization |
| Acceptability: Adherence rate | This outcome will be measured at the end of the 10-day intervention period. | Number of participants who completed the intervention modules as defined by the protocol. |
| Intervention satisfaction | The outcome will be assessed 1 week post-intervention. | Participant satisfaction will be explored via semi-structured one-to-one interviews to identify barriers and facilitators. |
| Adverse event | The outcome will be assessed through study completion, which is expected to be an average of 6 months. | Number of participants experiencing at least one adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic pain | Chronic pain will be assessed at pre-intervention and 1 week post-intervention. | 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. |
| 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. |
| 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. |
| VR experience | The Igroup presence questionnaire will be assessed pre-test and 1 week post-intervention | 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. |
| 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. |
| 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. |
Countries
Hong Kong
Outcome results
None listed