Adherence in Upper Extremity Home-based Rehabilitation

NYU Langone Health

Status: Completed

Conditions: Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05032638

21-00513

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Experimental Group

Experimental group

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.

Treatment:

Behavioral: Upper extremity (UE) Training

Behavioral: Therapist guided training