'leg amputation' 'lower limb amputation' paraplegia 'spinal cord injury' tetraplegia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Spinal cord injury or lower limb amputation - At least partly wheelchair dependent - Time since clinical rehabilitation * 1 year (chronic phase) - Age * 18 years - Access to a smartphone or tablet with internet connection and able to control it. - Inactivity as defined by a reference score of
Exclusion criteria
Exclusion criteria: - Cognitive impairments that impede use of the mobile lifestyle app. - Physical impairments that impede use of the mobile lifestyle app. - Progressive disease - Psychiatric disorders that impede participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Process factors: usability, ease of use and satisfaction with the app. These factors are measured using semi-structured interviews. The app to be developed will consist of 3 modules that focus on: 1) healthy physical behaviour (physical activity); 2) healthy eating habits; and 3) healthy relaxation and sleep habits. For evaluation of these 3 modules the primary study parameters are as follows: Module 1 - Physical activity will be measured using an activity monitor (acceleromete). The participants will wear this monitor as a watch around the wrist for five consecutive days (24 hours a day). The accelerometer data will be collected before, halfway and after the intervention. In addition, physical activity will be measured with an exercise diary that the participants can complete in the app. Module 2 - Total daily energy intake is measured with a 3-day food diary that will be completed before and after the intervention. - Body composition (bio-impedance analysis), body-mass index and waist circumference are measured before and after the intervention. Module 3 - The sleep-wake rhythm will be measured with the same accelerometer with which physical activity is measured. From the accelerometer data the following parameters will be distilled: total sleep time (time in bed), sleep period (actual minutes of sleep), nocturnal awakening and sleep efficiency (ratio between the total sleep time and the sleep period). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters: - Physical activity will be measured with the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD). - Multidimensional fatigue will be measured with the 20 items of the Individual Strength Checklist (CIS20R) - Self-efficacy will be measured with the Dutch version of the General Self Efficacy Scale (10 items) and the Spinal Cord Injury Exercise Self Efficacy Scale (10 items). - Health-related quality of life will be measured with the SF-36E. In this enabled version of the SF-36 the items of the physical functioning scale are adapted for use in wheelchair users. | — |
Countries
Netherlands