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Table 1 Schedule of assessments and overall measurements

From: Electrical stimulation to prevent recurring pressure ulcers in individuals with a spinal cord injury compared to usual care: the Spinal Cord Injury PREssure VOLTage (SCI PREVOLT) study protocol

Time (months)

0

1

2

3

4

5

6

7

8

9

10

11

12

Time points

T0

 

T1

 

T2

 

T3

Primary outcomes

 New PU*

 

X

X

X

X

X

X

X

X

X

X

X

X

 Picture

X

X

X

X

X

X

X

X

X

X

X

X

Secondary outcomes: PU risk factors

 Blood flow

X

 

X

 

X

 

X

 Muscle thickness

X

X

X

X

 Interface pressure distribution

X

X

X

X

Secondary outcomes: Questionnaires

 PASPID

X

 

X

 

X

 

X

 WHO-QoL-5

X

X

X

X

 USER-participation

X

X

X

X

 SIP-68

X

X

X

X

 HADS

X

X

X

X

 PSQI

X

X

X

X

 FSS

X

X

X

X

 Self-care capacity

X

X

X

X

Usability and user-friendliness of the ES system

 Self-administrated questionnaire

  

X

 

X

 

X

 

X

 Diary

X

X

X

X

X

X

X

X

X

X

X

X

Cost analysis

 EQ-5D-5L

X

 

X

 

X

 

X

 

X

 Online cost questionnaire

X

X

X

X

X

Process evaluation

 Questions of the RE-AIM model

 

X

 

X

 Interviews

X

X

 Focus group

 

X

  1. *Every 2 weeks (if the answer is yes, also data are collected about the number of days bedrest AND absence of work)
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Trials

ISSN: 1745-6215