Adherence in Upper Extremity Home-based Rehabilitation

NCT ID: NCT05032638

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-22
• Study Completion Date: 2022-10-24

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

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.

Group Type: EXPERIMENTAL

Therapist guided training

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Occupational Therapy Foundation

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grace Kim, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37113325 (View on PubMed)

Other Identifiers

21-00513

Identifier Type: -

Identifier Source: org_study_id