Adherence in Upper Extremity Home-based Rehabilitation

Stroke Clinical Trial

Official title:

Promoting Adherence in Upper Extremity Home-based Rehabilitation Through Motivational Interviewing and Ecological Momentary Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05032638
• Other study ID #: 21-00513
• Status: Completed
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: October 24, 2022

Study information

• Verified date: October 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 24, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Therapist guided training
Therapist guided period delivered virtually (WebEx/Zoom). Participants will be patients associated with NYULH and will have access to Zoom. Each session will last 45 min, and will completed 3x/week by research therapists, who are part of the study.
• Upper extremity (UE) Training
The 4-week UE training is completed in the participants home on their own and communication with study staff is virtual. Participants will receive daily communication through the Expiwell app to answer survey questions related to adherence, and safety/adverse events. Participants will also complete weekly check-ins with their research therapist over Zoom to answer questions about difficulties related to UE training activities, refinement of training goals, and to receive feedback on their training performance. Each weekly check-in will be approximately 45 minutes.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	American Occupational Therapy Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of adherence at individual and group level measured through frequency	Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period	Day 4 visit
Primary	Rates of adherence at individual and group level measured through frequency	Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period	Day 6 visit
Primary	Rates of adherence at individual and group level measured through frequency	Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period	Day 8 visit
Primary	Rates of adherence at individual and group level measured through frequency	Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period	Day 11 visit
Primary	Rates of adherence at individual and group level measured through frequency	Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period	Day 22 visit
Primary	Rates of adherence at individual and group level measured through frequency	Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period	Day 29 visit
Primary	Rates of adherence at individual and group level measured through frequency	Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period	Day 37 visit
Primary	Rates of adherence at individual and group level measured through frequency	Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period	Day 39 visit
Primary	Rates of adherence at individual and group level measured through intensity	Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).	Day 4 visit
Primary	Rates of adherence at individual and group level measured through intensity	Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).	Day 6 visit
Primary	Rates of adherence at individual and group level measured through intensity	Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).	Day 8 visit
Primary	Rates of adherence at individual and group level measured through intensity	Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).	Day 11 visit
Primary	Rates of adherence at individual and group level measured through intensity	Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).	Day 22 visit
Primary	Rates of adherence at individual and group level measured through intensity	Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).	Day 29 visit
Primary	Rates of adherence at individual and group level measured through intensity	Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).	Day 37 visit
Primary	Rates of adherence at individual and group level measured through intensity	Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).	Day 39 visit
Primary	Rates of adherence at individual and group level measured through duration	Duration data will be collected using open end responses to report total number of minutes of UE training completed that day	Day 4 visit
Primary	Rates of adherence at individual and group level measured through duration	Duration data will be collected using open end responses to report total number of minutes of UE training completed that day	Day 6 visit
Primary	Rates of adherence at individual and group level measured through duration	Duration data will be collected using open end responses to report total number of minutes of UE training completed that day	Day 8 visit
Primary	Rates of adherence at individual and group level measured through duration	Duration data will be collected using open end responses to report total number of minutes of UE training completed that day	Day 11 visit
Primary	Rates of adherence at individual and group level measured through duration	Duration data will be collected using open end responses to report total number of minutes of UE training completed that day	Day 22 visit
Primary	Rates of adherence at individual and group level measured through duration	Duration data will be collected using open end responses to report total number of minutes of UE training completed that day	Day 29 visit
Primary	Rates of adherence at individual and group level measured through duration	Duration data will be collected using open end responses to report total number of minutes of UE training completed that day	Day 37 visit
Primary	Rates of adherence at individual and group level measured through duration	Duration data will be collected using open end responses to report total number of minutes of UE training completed that day	Day 39 visit
Primary	Decision making factors effecting the program adherence through semi-structured interviews	Semi-structured interviews will be conducted with all participants to collect qualitative data on participants' experiences related to the shared decision-making process in phase 1, and adherence to arm training in phase 2 of study.	Day 39 visit
Secondary	Change scores in Fugl-Meyer Assessment from baseline to discharge and baseline to follow-up	FMA is a valid and reliable UE assessment to measure motor impairment in stroke. It consists of 33 items reflecting typical shoulder and hand motions in and out of synergy patterns characteristic of motor recovery after stroke. It is the gold standard performance-based assessment in UE stroke rehabilitation with an established minimal clinically important difference (MCID) of 4.25-7.25 points for chronic stroke patients.	Day 4 visit, Day 37-39 visit, Day 65-67 visit
Secondary	Change scores in Motor Activity Log from baseline to discharge and baseline to follow-up	Motor Activity Log (MAL) is a valid and reliable self-report questionnaire for individuals in the subacute and chronic phase after stroke. Originally created as the primary outcome for Constraint Induced Movement Therapy, the MAL captures spontaneous use of the affected UE in daily life. It consists of 28 items reflecting basic and instrumental activities of daily living items. Scoring is based on an ordinal scale ranging from 1-5, and final scores are determined by calculating the mean of all item scores. This study will use the amount of use subscale for this study.	Day 4 visit, Day 37-39 visit, Day 65-67 visit
Secondary	Change scores in Canadian Occupational Performance Measure from baseline to discharge and baseline to follow-up	The Canadian Occupational Performance Measure (COPM) is a valid and reliable individualized self-report measure that quantifies a participants' perception of everyday performance. Participants rate their change in their performance and satisfaction on a scale of 1 (unable to perform/not satisfied) to 10 (able to perform, extremely satisfied). A change of two or more points is considered clinically significant.	Day 4 visit, Day 37-39 visit, Day 65-67 visit
Secondary	Change scores in UE accelerometry data calculated using bilateral magnitude ratio from baseline to discharge and baseline to follow-up.	Wrist worn accelerometers can be used to provide objective, valid, and reliable data on general UE motion in home settings. As a secondary outcome for adherence, we will collect bilateral UE accelerometry data continuously for 24 hours at all timepoints to determine if there are any changes in UE motion of the affected side in relation to the unaffected side before and after the intervention. Commercially available Actigraph GT9X Link wrist sensors will be used to collect bilateral UE motion at baseline, discharge, and follow up.	Day 4 visit, Day 37-39 visit, Day 65-67 visit