Feasibility of a Remotely Delivered Step Count Intervention in Chronic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
The goal of this study is to explore the feasibility of a new approach to rehabilitation that focuses on step count. Participants will complete 6 telephone or Zoom-based sessions with an occupational therapist over 6 weeks and use a step count tracker during that time. They will also complete questionnaires, assessments, surveys, and physical activity measurements during study weeks 0 (baseline), 3 (mid-point), 7 (post-intervention) and 12 (follow-up).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Stroke diagnosis confirmed by imaging
Stroke occurred 6 or more months before study enrollment
Meet criteria for "inactive" on the International Physical Activity Questionnaire-Short Form
Able to identify a support person that they interact with in-person at least once per week
Disqualifiers
Currently receiving care in a transitional care unit, skilled nursing facility, or other institutional care setting
Currently receiving outpatient neurorehabilitation services (e.g., physical therapy, occupational therapy, speech therapy)
Severe cognitive or communication impairments (inability to respond accurately to complete study screening questions or to provide informed consent or assent)
Currently pregnant or expecting to become pregnant in the next 8 weeks Comorbid neurological disorder (Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis, dementia, Alzheimer's disease, Huntington's disease, glioblastoma, spinal cord injury, cerebral palsy)
Trial design
Design model
Single group
Treatments tested in this trial
Physical Activity Chats after Stroke (PA-ChatS)
BehavioralPA-ChatS consists of (1) self-monitoring step count using a pedometer, and (2) behavioral activation for stepping activity delivered via the telephone or Zoom and guided by the PA-ChatS workbook. Participants will receive education regarding physical activity after stroke, American Heart Association guidelines for post-stroke physical activity levels, and an overview of the intervention activities. They will then use a pedometer to monitor average daily step counts, set new step count goals (increasing by 5 to 10% of the daily average step count from the prior week), and create a specific plan for achieving the new step count goal. The interventionist will collaboratively problem solve with the participant to identify strategies to overcome barriers to stepping activity and maintain safety.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: PA-ChatS InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adherence to step count
The activPAL micro4 (24/7 wear protocol) will used to measure step count. The proportion of participants achieving 7500 or more steps per day will be reported.
Time frame
Week 7Secondary outcomes
1
Adherence to PA-ChatS sessions
Percentage of participants who complete 6 out of 6 (100%) of PA-ChatS sessions. Session completion will be documented by the study intervention therapist and total count of sessions completed will be computed after the last intervention session is delivered.
Time frame
6-weeks2
Acceptability of PA-ChatS Intervention
The Client Satisfaction Questionnaire-8 will be used to measure acceptability of the intervention. This is an 8-item measure with each item rated on a 1 to 4-point Likert-type scale, and then averaged across all 8 items. A mean score of 3 or more indicates that the intervention is generally acceptable.
Time frame
Week 73
Safety of the PA-ChatS Intervention
All participants will be queried regarding possible adverse events during the study at one time-point using an adverse events questionnaire previously administered in physical activity studies after stroke. The total count of adverse events that are possibly or definitely related to this intervention will be reported.
Time frame
Week 74
Adherence to step count
The activPAL micro4 (24/7 wear protocol) will used to measure step count. The proportion of participants achieving 7500 or more steps per day will be reported.
Time frame
Week 12Sponsors and contacts
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Source ClinicalTrials.gov