Ignite Creation Date:
2024-05-06 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05187975
Status:
RECRUITING
Last Update Posted:
2022-06-24
First Post:
2021-12-03
Brief Title:
Integrated Rehabilitation in Treating Post-stroke Depression
Sponsor:
The Third Affiliated hospital of Zhejiang Chinese Medical University
Organization:
The Third Affiliated hospital of Zhejiang Chinese Medical University
Study Overview
Official Title:
Integrated Rehabilitation in Treating Post-stroke Depression Study Protocol for a Multicentre Prospective Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2022-06
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:
IRTPD
Brief Summary:
Post-stroke depression PSD is a common complication of stroke that leads to dysfunction and reduces the quality of life PSD exacerbates cognitive dysfunction delays the recovery process and increases the disability mortality and recurrence rates of stroke Therefore early clinical treatments for PSD are important to improve the prognosis and restore the social functions of stroke patients
Integrated rehabilitation has significant advantages in the treatment of PSD First of all there is a wide range of rehabilitation methods such as acupuncture traditional Chinese medicine and repetitive transcranial magnetic stimulation which have been proved to be effective for PSD However as the application of integrated rehabilitation becomes more and more widespread its shortcomings are gradually emerging For example most of the treatment protocols used in clinical studies are based on personal experience of the investigators a unified protocol has not yet been formed treatment methods are still insufficient in standardization and reproducibility More studies focus solely on the improvement of a certain symptom by a certain rehabilitation therapy but ignore the important theoretical basis of the holistic concept thus showing the uneven clinical efficacy For the above existing problems it is necessary to conduct original and innovative research
Integrated rehabilitation has significant advantages in the treatment of PSD First of all there is a wide range of rehabilitation methods such as acupuncture traditional Chinese medicine and repetitive transcranial magnetic stimulation which have been proved to be effective for PSD However as the application of integrated rehabilitation becomes more and more widespread its shortcomings are gradually emerging For example most of the treatment protocols used in clinical studies are based on personal experience of the investigators a unified protocol has not yet been formed treatment methods are still insufficient in standardization and reproducibility More studies focus solely on the improvement of a certain symptom by a certain rehabilitation therapy but ignore the important theoretical basis of the holistic concept thus showing the uneven clinical efficacy For the above existing problems it is necessary to conduct original and innovative research
Detailed Description:
This randomized controlled trial will enroll 202 PSD patients from the Third Affiliated Hospital of Zhejiang Chinese Medical University Zhejiang General Hospital of Armed Police Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University and Jinhua Second Hospital All patients will be randomly assigned to either the integrated rehabilitation group or the standard care group through a randomization system The primary outcome will be assessed by hamilton depression HAMD scale self-rating depression scale SDS and activity of daily living ADL scale Secondary outcomes will include montreal cognitive assessment MoCA scale the simple fugl-meyer assessment of motor function FMA scale and pittsburgh sleep quality index PSQI
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