Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446596
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-31
Brief Title:
TRAK vs Standard Home-based Exercise in Low Back Pain
Sponsor:
University of Valencia
Organization:
University of Valencia
Study Overview
Official Title:
Effect of the Implementation of the TRAK Application Compared to the Standard Use of Exercise Dossier and Intervention Diary in a Home Therapeutic Exercise Intervention in Patients With Low Back Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the study is to compare the effect of a home therapeutic exercise intervention scheduled through the application of digital physiotherapy and telerehabilitation TRAK versus a home therapeutic exercise program scheduled through a dossier and an exercise diary with respect to disability measured using the OSWESTRY questionnaire and other variables range of motion strength fatigue histological changes pain medication intake psychosocial factors and adherence in patients with low back pain
Detailed Description:
The objective of the study is to compare the effect of a home therapeutic exercise intervention scheduled through the application of digital physiotherapy and telerehabilitation TRAK versus a home therapeutic exercise program scheduled through a dossier and an exercise diary with respect to disability measured using the OSWESTRY questionnaire and other variables range of motion strength fatigue histological changes pain medication intake psychosocial factors and adherence in patients with low back pain
This randomized controlled trial has a parallel design with two groups Both groups will complete an 8-week home exercise program that includes flexibility and strength exercises The program will be carried out with a frequency of 3 weekly sessions preferably on alternate days In the case of the experimental group the program will be carried out with the support of the TRAK computer tool httpswwwtrakphysiocomes which allows the exercises to be carried out in front of a camera that with the help of an artificial intelligence system offers feedback to the participant and allows investigatorsclinicians to keep a record of the sessions In the case of the control group the program will be carried out with the support of an information dossier of the exercises to be performed and a monitoring diary in which everything related to the sessions carried out will be noted In both groups as an addition to the home sessions two face-to-face sessions will be held in the first and fifth weeks respectively
The exercise program includes flexibility and strength exercises each made up of three levels of difficulty easy intermediate and difficult with patients advancing to subsequent levels once each level is successfully overcome
This randomized controlled trial has a parallel design with two groups Both groups will complete an 8-week home exercise program that includes flexibility and strength exercises The program will be carried out with a frequency of 3 weekly sessions preferably on alternate days In the case of the experimental group the program will be carried out with the support of the TRAK computer tool httpswwwtrakphysiocomes which allows the exercises to be carried out in front of a camera that with the help of an artificial intelligence system offers feedback to the participant and allows investigatorsclinicians to keep a record of the sessions In the case of the control group the program will be carried out with the support of an information dossier of the exercises to be performed and a monitoring diary in which everything related to the sessions carried out will be noted In both groups as an addition to the home sessions two face-to-face sessions will be held in the first and fifth weeks respectively
The exercise program includes flexibility and strength exercises each made up of three levels of difficulty easy intermediate and difficult with patients advancing to subsequent levels once each level is successfully overcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None