Ignite Creation Date:
2024-07-17 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498453
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
Effectiveness of Telerehabilitation With Trak in Knee and Shoulder Pathology A Randomized Clinical Trial
Sponsor:
Trak Health Solutions SL
Organization:
Trak Health Solutions SL
Study Overview
Official Title:
A Randomized Clinical Trial to Evaluate the Effectiveness of Telerehabilitation With Trak in Patients With Knee or Shoulder Pathology
Status:
COMPLETED
Status Verified Date:
2024-07
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:
TRAK-TEST
Brief Summary:
The main objective of this clinical trial is to compare the effectiveness of digital physiotherapy treatment using the Trak telerehabilitation platform and the application of conventional means on two different health conditions mild or moderate knee osteoarthritis and shoulder tendinopathy
Participants will undergo telerehabilitation treatment through the TRAK platform for six weeks treatment group or follow the instructions and guidelines collected by health personnel for the same time in face-to-face rehabilitation sessions control group
Participants will undergo telerehabilitation treatment through the TRAK platform for six weeks treatment group or follow the instructions and guidelines collected by health personnel for the same time in face-to-face rehabilitation sessions control group
Detailed Description:
The recruitment process for this study is aimed at adults who suffer from musculoskeletal pathologies of the knee mild or moderate osteoarthritis or shoulder tendinopathy
After the initial screening individuals who meet the studys predefined inclusion criteria will be invited to participate Before enrollment written informed consent will be obtained from all participants ensuring ethical compliance and respect for individual autonomy
The study cohort will consist of patients randomly assigned to the experimental group EG and the control group CG on both knee and shoulder groups This randomised controlled trial has a parallel design with two groups Regardless of group assignment all patients will undergo baseline health assessments ensuring that their individual needs are met The satisfaction questionnaire will be deferred until post-intervention for both groups
Patients will undergo 6 weeks of treatment with 18 telerehabilitation sessions through the TRAK tool httpswwwtrakphysiocomes in the shoulder group and 12 sessions for the knee group Patients from the EG will carry out the treatment through the platform at home and those from the CG will follow an exercise protocol based on the usual in-person clinical practice methodology Both groups will perform exercises in these rehabilitation sessions to improve mobility and strength and reduce pain
In phase 1 3 weeks all groups will undergo two weeks of in-person treatment based on established drainage technique and TENS application ensuring the treatments safety and efficacy In addition the patients will begin with in-person CG or remote treatment EG depending on the case In the second phase or phase 2 3 more weeks patients will perform the exercises at home EG or at the medical center CG
The results will be evaluated using different scales such as the DASH scale and the KOOS-PS scale as well as other secondary scales assessing strength mobility pain and patient satisfaction These measurements will be collected at the beginning and end of the proposed treatment These scales will be completed on paper at the beginning and end of the study for both groups although the daily scales pain mobility and strength will be completed through the platform in the case of the treatment group
After the initial screening individuals who meet the studys predefined inclusion criteria will be invited to participate Before enrollment written informed consent will be obtained from all participants ensuring ethical compliance and respect for individual autonomy
The study cohort will consist of patients randomly assigned to the experimental group EG and the control group CG on both knee and shoulder groups This randomised controlled trial has a parallel design with two groups Regardless of group assignment all patients will undergo baseline health assessments ensuring that their individual needs are met The satisfaction questionnaire will be deferred until post-intervention for both groups
Patients will undergo 6 weeks of treatment with 18 telerehabilitation sessions through the TRAK tool httpswwwtrakphysiocomes in the shoulder group and 12 sessions for the knee group Patients from the EG will carry out the treatment through the platform at home and those from the CG will follow an exercise protocol based on the usual in-person clinical practice methodology Both groups will perform exercises in these rehabilitation sessions to improve mobility and strength and reduce pain
In phase 1 3 weeks all groups will undergo two weeks of in-person treatment based on established drainage technique and TENS application ensuring the treatments safety and efficacy In addition the patients will begin with in-person CG or remote treatment EG depending on the case In the second phase or phase 2 3 more weeks patients will perform the exercises at home EG or at the medical center CG
The results will be evaluated using different scales such as the DASH scale and the KOOS-PS scale as well as other secondary scales assessing strength mobility pain and patient satisfaction These measurements will be collected at the beginning and end of the proposed treatment These scales will be completed on paper at the beginning and end of the study for both groups although the daily scales pain mobility and strength will be completed through the platform in the case of the treatment group
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