Study Summary
This trial will test a new method of stroke rehabilitation that involves the care partner, to see if it leads to better outcomes.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 10 Secondary · Reporting Duration: Baseline, 1 week post-intervention, 1 month follow up post-intervention
1 month post intervention
Carepartner satisfaction
Carepartners adherence rate
Recruitment rate
Retention rate
Stroke survivors adherence rate
Month 1
Change in Post-Study System Usability Questionnaire (PSSUQ)
Month 1
Change in Bakas Caregiving Outcomes Scale (BCOS) Score
Change in Caregiver Strain assessed by the Caregiver Strain Index (CSI)
Change in Family Care Climate Questionnaire - Carepartners (FCCQ-CP) Score
Change in Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score
Change in Five Times Sit-To-Stand (5TSTS) score
Change in SS Quality of Life using Stroke Impact Scale (SIS) score
Change in carepartners Family Conflict using Family Caregiver Conflict Scale (FCCS) score
Change in lower extremity Fugl-Meyer (FM) therapist standardized assessment score
Change in stroke survivor endurance
Change in stroke survivor gait speed
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
CARE-CITE GAIT Carepartner
1 of 2
CARE-CITE GAIT Stroke Survivor
1 of 2
Experimental Treatment
32 Total Participants · 2 Treatment Groups
Primary Treatment: CARE-CITE Gait · No Placebo Group · N/A
CARE-CITE GAIT Carepartner
Behavioral
Experimental Group · 1 Intervention: CARE-CITE Gait · Intervention Types: BehavioralCARE-CITE GAIT Stroke Survivor
Behavioral
Experimental Group · 1 Intervention: CARE-CITE Gait · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 week post-intervention, 1 month follow up post-intervention
Who is running the clinical trial?
Foundation for Physical Therapy, Inc.Industry Sponsor
11 Previous Clinical Trials
451 Total Patients Enrolled
Emory UniversityLead Sponsor
1,523 Previous Clinical Trials
2,713,487 Total Patients Enrolled
26 Trials studying Stroke
347,034 Patients Enrolled for Stroke
Sarah Blanton, PT, DPTPrincipal InvestigatorEmory University
1 Previous Clinical Trials
46 Total Patients Enrolled
1 Trials studying Stroke
46 Patients Enrolled for Stroke
Eligibility Criteria
Age Any Age · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Georgia | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Emory Hospital | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |