Clinical trial NCT05032638: Adherence in Upper Extremity Home-based Rehabilitation
Official title: Promoting Adherence in Upper Extremity Home-based Rehabilitation Through Motivational Interviewing and Ecological Momentary Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
upper extremity
motivational interviewing
shared decision making
ecological momentary assessments
self-initiated training
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: American Occupational Therapy Foundation
First posted: 2021-09-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the proposal is to determine the feasibility of implementing Ecological Momentary Assessment (EMA) and Motivational Interviewing (MI) methods to enhance adherence for a 4-week self-initiated arm training protocol. A non-randomized feasibility study using a 4-week UE training protocol will be conducted in 15 individuals within the first 12 months post-stroke living in the community. EMA data will be collected using a mobile app to automate real-time collection of adherence data on a daily basis. MI will be used to produce self-generated training plans (training goals, training schedule), guided by the therapist before the start of training.

Detailed description: Using a mixed methods design, the study will collect quantitative data before, during, and after training. Qualitative data will be collected after the training period and analyzed to explain the quantitative findings in depth, within the context of everyday life. Study aim 1 is to evaluate the feasibility of using EMA to measure adherence and of applying the MI approach. Quantitative data will include four indicators of adherence and accuracy. Interview responses will be used as qualitative data to elucidate participants' acceptance of the MI approach and feedback on using the EMA app. Study aim 2 is to explore to what extent UE outcomes change after the 4-week self-initiated home-based rehabilitation program. Outcomes will include UE use in real-world environments and self-perceived changes in UE use.

Eligibility criteria: Inclusion Criteria:

* Adults (\> 18 years old) diagnosed with stroke at least 6 months ago at the time of screening
* Living in the community
* Have presence of UE motor impairment on the affected side (Fugl-Meyer Assessment scores \< 66)
* Availability of mobile technology (tablet or smartphone) with internet connection to use phone app and Zoom videochat)
* Be medically stable
* Able to provide written consent

Exclusion Criteria:

* Currently receiving active occupational or physical therapy for the treatment of the affected UE
* Presence of severe cognitive impairment (Mini Mental Status Exam \<24)
* Self-reported moderate to severe pain of the affected UE with use
* Presence of unilateral spatial neglect (Star Cancellation Task scores \< 44)
* Presence of neurological diagnosis other than stroke.

Primary outcomes:
measure: Rates of adherence at individual and group level measured through frequency
timeFrame: Day 4 visit
measure: Rates of adherence at individual and group level measured through frequency
timeFrame: Day 6 visit
measure: Rates of adherence at individual and group level measured through frequency
timeFrame: Day 8 visit
measure: Rates of adherence at individual and group level measured through frequency
timeFrame: Day 11 visit
measure: Rates of adherence at individual and group level measured through frequency
timeFrame: Day 22 visit
measure: Rates of adherence at individual and group level measured through frequency
timeFrame: Day 29 visit
measure: Rates of adherence at individual and group level measured through frequency
timeFrame: Day 37 visit
measure: Rates of adherence at individual and group level measured through frequency
timeFrame: Day 39 visit
measure: Rates of adherence at individual and group level measured through intensity
timeFrame: Day 4 visit
measure: Rates of adherence at individual and group level measured through intensity
timeFrame: Day 6 visit
measure: Rates of adherence at individual and group level measured through intensity
timeFrame: Day 8 visit
measure: Rates of adherence at individual and group level measured through intensity
timeFrame: Day 11 visit
measure: Rates of adherence at individual and group level measured through intensity
timeFrame: Day 22 visit
measure: Rates of adherence at individual and group level measured through intensity
timeFrame: Day 29 visit
measure: Rates of adherence at individual and group level measured through intensity
timeFrame: Day 37 visit
measure: Rates of adherence at individual and group level measured through intensity
timeFrame: Day 39 visit
measure: Rates of adherence at individual and group level measured through duration
timeFrame: Day 4 visit
measure: Rates of adherence at individual and group level measured through duration
timeFrame: Day 6 visit
measure: Rates of adherence at individual and group level measured through duration
timeFrame: Day 8 visit
measure: Rates of adherence at individual and group level measured through duration
timeFrame: Day 11 visit
measure: Rates of adherence at individual and group level measured through duration
timeFrame: Day 22 visit
measure: Rates of adherence at individual and group level measured through duration
timeFrame: Day 29 visit
measure: Rates of adherence at individual and group level measured through duration
timeFrame: Day 37 visit
measure: Rates of adherence at individual and group level measured through duration
timeFrame: Day 39 visit
measure: Decision making factors effecting the program adherence through semi-structured interviews
timeFrame: Day 39 visit
Secondary outcomes:
measure: Change scores in Fugl-Meyer Assessment from baseline to discharge and baseline to follow-up
timeFrame: Day 4 visit, Day 37-39 visit, Day 65-67 visit
measure: Change scores in Motor Activity Log from baseline to discharge and baseline to follow-up
timeFrame: Day 4 visit, Day 37-39 visit, Day 65-67 visit
measure: Change scores in Canadian Occupational Performance Measure from baseline to discharge and baseline to follow-up
timeFrame: Day 4 visit, Day 37-39 visit, Day 65-67 visit
measure: Change scores in UE accelerometry data calculated using bilateral magnitude ratio from baseline to discharge and baseline to follow-up.
timeFrame: Day 4 visit, Day 37-39 visit, Day 65-67 visit
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Grace Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: