Back to resultsAdherence in Upper Extremity Home-based Rehabilitation
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapist guided training
Upper extremity (UE) Training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, upper extremity, motivational interviewing, shared decision making, ecological momentary assessments, self-initiated training
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.
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Group
Arm Description
Subjects with motor impairment will work closely with an occupational therapist to identify a goal and select activities that they will work on at home to improve the function of their affected arm.
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
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
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
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).
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).
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).
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).
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).
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).
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).
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).
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
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
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
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
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
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
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
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
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05032638
First Posted
August 26, 2021
Last Updated
October 31, 2022
Sponsor
NYU Langone Health
Collaborators
American Occupational Therapy Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05032638
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
October 24, 2022 (Actual)
Study Completion Date
October 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
American Occupational Therapy Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, upper extremity, motivational interviewing, shared decision making, ecological momentary assessments, self-initiated training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Subjects with motor impairment will work closely with an occupational therapist to identify a goal and select activities that they will work on at home to improve the function of their affected arm.
Intervention Type
Behavioral
Intervention Name(s)
Therapist guided training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Upper extremity (UE) Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rates of adherence at individual and group level measured through frequency
Description
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Time Frame
Day 4 visit
Title
Rates of adherence at individual and group level measured through frequency
Description
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Time Frame
Day 6 visit
Title
Rates of adherence at individual and group level measured through frequency
Description
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Time Frame
Day 8 visit
Title
Rates of adherence at individual and group level measured through frequency
Description
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Time Frame
Day 11 visit
Title
Rates of adherence at individual and group level measured through frequency
Description
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Time Frame
Day 22 visit
Title
Rates of adherence at individual and group level measured through frequency
Description
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Time Frame
Day 29 visit
Title
Rates of adherence at individual and group level measured through frequency
Description
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Time Frame
Day 37 visit
Title
Rates of adherence at individual and group level measured through frequency
Description
Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period
Time Frame
Day 39 visit
Title
Rates of adherence at individual and group level measured through intensity
Description
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Time Frame
Day 4 visit
Title
Rates of adherence at individual and group level measured through intensity
Description
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Time Frame
Day 6 visit
Title
Rates of adherence at individual and group level measured through intensity
Description
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Time Frame
Day 8 visit
Title
Rates of adherence at individual and group level measured through intensity
Description
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Time Frame
Day 11 visit
Title
Rates of adherence at individual and group level measured through intensity
Description
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Time Frame
Day 22 visit
Title
Rates of adherence at individual and group level measured through intensity
Description
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Time Frame
Day 29 visit
Title
Rates of adherence at individual and group level measured through intensity
Description
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Time Frame
Day 37 visit
Title
Rates of adherence at individual and group level measured through intensity
Description
Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).
Time Frame
Day 39 visit
Title
Rates of adherence at individual and group level measured through duration
Description
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Time Frame
Day 4 visit
Title
Rates of adherence at individual and group level measured through duration
Description
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Time Frame
Day 6 visit
Title
Rates of adherence at individual and group level measured through duration
Description
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Time Frame
Day 8 visit
Title
Rates of adherence at individual and group level measured through duration
Description
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Time Frame
Day 11 visit
Title
Rates of adherence at individual and group level measured through duration
Description
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Time Frame
Day 22 visit
Title
Rates of adherence at individual and group level measured through duration
Description
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Time Frame
Day 29 visit
Title
Rates of adherence at individual and group level measured through duration
Description
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Time Frame
Day 37 visit
Title
Rates of adherence at individual and group level measured through duration
Description
Duration data will be collected using open end responses to report total number of minutes of UE training completed that day
Time Frame
Day 39 visit
Title
Decision making factors effecting the program adherence through semi-structured interviews
Description
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.
Time Frame
Day 39 visit
Secondary Outcome Measure Information:
Title
Change scores in Fugl-Meyer Assessment from baseline to discharge and baseline to follow-up
Description
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.
Time Frame
Day 4 visit, Day 37-39 visit, Day 65-67 visit
Title
Change scores in Motor Activity Log from baseline to discharge and baseline to follow-up
Description
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.
Time Frame
Day 4 visit, Day 37-39 visit, Day 65-67 visit
Title
Change scores in Canadian Occupational Performance Measure from baseline to discharge and baseline to follow-up
Description
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.
Time Frame
Day 4 visit, Day 37-39 visit, Day 65-67 visit
Title
Change scores in UE accelerometry data calculated using bilateral magnitude ratio from baseline to discharge and baseline to follow-up.
Description
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.
Time Frame
Day 4 visit, Day 37-39 visit, Day 65-67 visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Kim, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.The investigator who proposed to use the data.
IPD Sharing Access Criteria
Upon reasonable request. Requests should be directed to gjk207@nyu.edu. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Adherence in Upper Extremity Home-based Rehabilitation
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