Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-21
Brief Title:
Home Tele Rehabilitation Therapy for Vascular Dementia
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Home Tele Rehabilitation Therapy for Vascular Dementia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
To determine whether the home telerehabilitation therapy is feasible and lessens caregiver burden in chronic stroke patients with and without vascular dementia VaD
Detailed Description:
This is a controlled evaluator masked parallel study of chronic 6mo from stroke onset ischemic or hemorrhagic stroke patients diagnosed with and without vascular dementia to test the feasibility and effect of remote rehabilitation therapy targeting the weaker arm compared to usual care All patients will undergo baseline evaluation then usual care for 1 month followed by a remote telerehabilitation treatment for one month followed by an evaluation 1 month after the completion of treatment
Research procedures
Subject RecruitmentScreening Participants will be recruited from the PIs stroke recovery specialty clinic and the Houston Methodist Hospital system by flyers and educating clinicians about the proposed study and the patient requirements Prospective participants may also be identified through mining electronic medical records for ICD-9 and ICD-10 codes for stroke and hemiparesis for potentially eligible participants Participants that appear to meet eligibility criteria based on the phone screening and medical record review will be invited to participate in an in-person screening session to ensure that they met the full inclusion criteria prior to being enrolled in the study
Throughout all study visits subjects will be monitored for safety comfort and any adverse events by trained study staff
Initial EvaluationDependent Measures The subjects initial evaluation will include questionnaires and impairment and functional scales We will record demographic information brain imaging stroke history and medical history and medications from electronic medical records We will store the deidentified brain imaging in XNAT under a study identifier on the secure server available at HMH
Intervention
All subjects will perform first their conventional home rehabilitation for 4 weeks followed by telerehabilitation therapy
Occupational therapist prescribed handarm exercises will continue for 90 minutes per day with adequate rest periods
Self-report measures will not be blinded The investigator who determines the primary outcome measure will not be aware of treatment phase completed or prior performance single-blind study design Each treatment session will be expected to take approximately 1 hour 45 minute with prior setup and stretching Treatment times can be broken up into multiple treatment periods to accommodate patient and caregiver preferences
Research procedures
Subject RecruitmentScreening Participants will be recruited from the PIs stroke recovery specialty clinic and the Houston Methodist Hospital system by flyers and educating clinicians about the proposed study and the patient requirements Prospective participants may also be identified through mining electronic medical records for ICD-9 and ICD-10 codes for stroke and hemiparesis for potentially eligible participants Participants that appear to meet eligibility criteria based on the phone screening and medical record review will be invited to participate in an in-person screening session to ensure that they met the full inclusion criteria prior to being enrolled in the study
Throughout all study visits subjects will be monitored for safety comfort and any adverse events by trained study staff
Initial EvaluationDependent Measures The subjects initial evaluation will include questionnaires and impairment and functional scales We will record demographic information brain imaging stroke history and medical history and medications from electronic medical records We will store the deidentified brain imaging in XNAT under a study identifier on the secure server available at HMH
Intervention
All subjects will perform first their conventional home rehabilitation for 4 weeks followed by telerehabilitation therapy
Occupational therapist prescribed handarm exercises will continue for 90 minutes per day with adequate rest periods
Self-report measures will not be blinded The investigator who determines the primary outcome measure will not be aware of treatment phase completed or prior performance single-blind study design Each treatment session will be expected to take approximately 1 hour 45 minute with prior setup and stretching Treatment times can be broken up into multiple treatment periods to accommodate patient and caregiver preferences
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