NCT05257928

Carepartner Collaborative Integrated Therapy Gait (CARE-CITE-Gait) Program

Completed NA Last updated 22 September 2023

What this trial tests

NA trial testing CARE-CITE Gait in Stroke in 32 participants. Completed in 31 May 2023.

Timeline

18 May 2022

Primary endpoint
24 May 2023

31 May 2023

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	18 May 2022
Primary completion	24 May 2023
Estimated completion	31 May 2023
Sites	1 location across United States

Drugs / interventions tested

• CARE-CITE Gait

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Emory University

Who can join

Eligibility, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Stroke affects both the carepartner (CP) and stroke survivor (SS), with CPs frequently feeling overwhelmed and exhausted. The investigators have developed a theory-based, family-centered intervention, Carepartner Collaborative Integrated Therapy (CARE-CITE) designed to positively engage CPs during SS daily activities and rehabilitation exercise practice in the home setting. Using a web-based program with exemplary interactive videos of family scenarios in the home, CARE-CITE guides the CP in collaborative goal setting and creating an autonomy-supportive environment with the SS to promote motivation and creative problem-solving.

This study will use the modified upper extremity-focused CARE-CITE intervention content to address gait rehabilitation, and test 4-weeks of CARE-CITE-Gait in 15 CP/SS dyads to determine if similar positive outcomes are seen with integration to gait rehabilitation. Over a period of one month, SS and CP will receive 2 two-hour home-based therapy visits with a licensed physical therapist to develop therapy goals related to gait, mobility and balance and develop a home exercise plan to improve function. The CP will receive two additional phone calls to discuss the online CARE-CITE educational modules. The overall impact of this work is the development of innovative family-centered telerehabilitation interventions to improve self-management and physical activity.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluation of a carepartner-integrated telehealth gait rehabilitation program for persons with stroke: study protocol for a feasibility study.
   Blanton S, Cotsonis G, Brennan K, Song R, et al · · 2023 · cited 2× · PMID 38001523 · DOI 10.1186/s40814-023-01411-1
2. Evaluation of a Carepartner-Integrated Telehealth Gait Rehabilitation Program for Persons with Stroke : Study Protocol for a Feasibility Study
   Blanton S, Cotsonis G, Brenan K, Song R, et al · · 2023 · DOI 10.21203/rs.3.rs-2689016/v1