Adherence in Upper Extremity Home-based Rehabilitation

NCT05032638 | Completed DMC

• 1 other identifier: 21-00513
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; upper extremity; motivational interviewing; shared decision making; ecological momentary assessments; self-initiated training

Outcome Measures

Primary Outcomes (25)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

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

  Day 4 visit, Day 37-39 visit, Day 65-67 visit

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

  Day 4 visit, Day 37-39 visit, Day 65-67 visit

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

  Day 4 visit, Day 37-39 visit, Day 65-67 visit

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

  Day 4 visit, Day 37-39 visit, Day 65-67 visit

Study Arms (1)

Experimental Group

EXPERIMENTAL

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.

Behavioral: Therapist guided training; Behavioral: Upper extremity (UE) Training

Interventions

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.

Experimental Group

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• American Occupational Therapy Foundation: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• Kim GJ, Gahlot A, Magsombol C, Waskiewicz M, Capasso N, Van Lew S, Goverover Y, Dickson VV. Protocol for a remote home-based upper extremity self-training program for community-dwelling individuals after stroke. Contemp Clin Trials Commun. 2023 Mar 17;33:101112. doi: 10.1016/j.conctc.2023.101112. eCollection 2023 Jun.

  PMID: 37113325 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Grace Kim, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 2, 2021
• Study Start: September 22, 2021
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)