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Completed

NCT Number: NCT05032638

Adherence in Upper Extremity Home-based Rehabilitation

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapist guided training

Behavioral

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

Behavioral

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 outcomes

  1. Rates of adherence at individual and group level measured through frequency

    Time frame: Day 4 visit

    Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period

  2. Rates of adherence at individual and group level measured through frequency

    Time frame: Day 6 visit

    Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period

  3. Rates of adherence at individual and group level measured through frequency

    Time frame: Day 8 visit

    Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period

  4. Rates of adherence at individual and group level measured through frequency

    Time frame: Day 11 visit

    Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period

  5. Rates of adherence at individual and group level measured through frequency

    Time frame: Day 22 visit

    Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period

  6. Rates of adherence at individual and group level measured through frequency

    Time frame: Day 29 visit

    Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period

  7. Rates of adherence at individual and group level measured through frequency

    Time frame: Day 37 visit

    Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period

  8. Rates of adherence at individual and group level measured through frequency

    Time frame: Day 39 visit

    Frequency will be calculated by dividing the number of sessions completed by the total number of sessions available for 4-week period

  9. Rates of adherence at individual and group level measured through intensity

    Time frame: Day 4 visit

    Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).

  10. Rates of adherence at individual and group level measured through intensity

    Time frame: Day 6 visit

    Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).

  11. Rates of adherence at individual and group level measured through intensity

    Time frame: Day 8 visit

    Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).

  12. Rates of adherence at individual and group level measured through intensity

    Time frame: Day 11 visit

    Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).

  13. Rates of adherence at individual and group level measured through intensity

    Time frame: Day 22 visit

    Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).

  14. Rates of adherence at individual and group level measured through intensity

    Time frame: Day 29 visit

    Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).

  15. Rates of adherence at individual and group level measured through intensity

    Time frame: Day 37 visit

    Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).

  16. Rates of adherence at individual and group level measured through intensity

    Time frame: Day 39 visit

    Intensity data will be collected using a 3-point ordinal ratings scale to determine perceived intensity of practice for each session (mild- moderate- intense).

  17. Rates of adherence at individual and group level measured through duration

    Time frame: Day 4 visit

    Duration data will be collected using open end responses to report total number of minutes of UE training completed that day

  18. Rates of adherence at individual and group level measured through duration

    Time frame: Day 6 visit

    Duration data will be collected using open end responses to report total number of minutes of UE training completed that day

  19. Rates of adherence at individual and group level measured through duration

    Time frame: Day 8 visit

    Duration data will be collected using open end responses to report total number of minutes of UE training completed that day

  20. Rates of adherence at individual and group level measured through duration

    Time frame: Day 11 visit

    Duration data will be collected using open end responses to report total number of minutes of UE training completed that day

  21. Rates of adherence at individual and group level measured through duration

    Time frame: Day 22 visit

    Duration data will be collected using open end responses to report total number of minutes of UE training completed that day

  22. Rates of adherence at individual and group level measured through duration

    Time frame: Day 29 visit

    Duration data will be collected using open end responses to report total number of minutes of UE training completed that day

  23. Rates of adherence at individual and group level measured through duration

    Time frame: Day 37 visit

    Duration data will be collected using open end responses to report total number of minutes of UE training completed that day

  24. Rates of adherence at individual and group level measured through duration

    Time frame: Day 39 visit

    Duration data will be collected using open end responses to report total number of minutes of UE training completed that day

  25. Decision making factors effecting the program adherence through semi-structured interviews

    Time frame: Day 39 visit

    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 outcomes

  1. Change scores in Fugl-Meyer Assessment from baseline to discharge and baseline to follow-up

    Time frame: Day 4 visit, Day 37-39 visit, Day 65-67 visit

    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.

  2. Change scores in Motor Activity Log from baseline to discharge and baseline to follow-up

    Time frame: Day 4 visit, Day 37-39 visit, Day 65-67 visit

    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.

  3. Change scores in Canadian Occupational Performance Measure from baseline to discharge and baseline to follow-up

    Time frame: Day 4 visit, Day 37-39 visit, Day 65-67 visit

    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.

  4. Change scores in UE accelerometry data calculated using bilateral magnitude ratio from baseline to discharge and baseline to follow-up.

    Time frame: Day 4 visit, Day 37-39 visit, Day 65-67 visit

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • American Occupational Therapy Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 2, 2021
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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