Exercise, Stroke
Conditions
Brief summary
This project evaluates the feasibility of using custom wearable technology and associated procedures to increase activity of the more-involved upper extremity during the earliest stages of recovery from stroke by increasing the amount of therapeutic exercise during idle-time. The proposed research is relevant to public health because it takes steps to mitigate a significant problem in physical rehabilitation using low-cost technology to motivate and monitor idle-time exercise without adding significantly to clinician workloads. The project aligns with the NICHD / NCMRR Research Plan on Rehabilitation by exploiting a mobile health (mHealth) and sensor-based approach to promote health and wellness through participant-engaged, data-driven, individualized care.
Detailed description
The experiments in this proposal will assess the functional utility and subjective patient experience using a personal exercise cueing system designed to reduce learned non-use of the hemiparetic arm in the days, and weeks immediately following stroke. Up to 36 stroke survivors will be asked to participate in 12 practice sessions each lasting approximately 90 minutes. Participants will be asked to perform simple exercises after receiving a vibration cue. In the first four sessions participants will tap the more-involved wrist; in the second four sessions they will passively move the more-involved elbow through a range of motion; in the final four sessions they will actively move the more-involved elbow through a range of motion. Accelerometers in the wearable devices will monitor motion of the wrist during the exercise sessions. To verify functional utility of the system, the investigators will examine for differences in the duration of arm movement activity in the cued exercise sessions relative to uncued periods. After all the sessions are complete, subjective user experience will be assessed by asking participants to complete a series of surveys wherein they can provide information about their subjective experiences with the wearable device technology. To assess feasibility of long-term follow-up, the investigators will interview the participants two months later regarding how well they use the more-involved arm to perform daily activities. At this time, they will also be asked to wear the devices for two days to assess the ability to measure arm movement activity at follow-up.
Interventions
BEHAVIORALFeasibility of idle time exercise
The experiments in this proposal will assess the utility and subjective patient experience performing idle time exercise intervention designed to reduce learned non-use of the hemiparetic arm in the days, and weeks immediately following stroke. Exercise will be cued by wearable technology that provides vibrotactile cues similar to those provided by FitBit devices. Participants will be asked to perform simple exercises after receiving a vibration cue. In the first four sessions they will tap the more-involved wrist; in the second four sessions they will passively move the more-involved elbow through a range of motion; in the final four sessions they will actively move the more-involved elbow through a range of motion. Accelerometers in the wearable devices will monitor motion of the wrist during the exercise sessions. We will interview the participants two months later regarding how well they use the more-involved arm to perform daily activities.
Sponsors
Marquette University
Medical College of Wisconsin
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Survivors of stroke in early stages of recovery
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(General): The goal of this feasibility clinical trial is to assess the functional utility and subjective patient experience using a personal exercise cueing system designed to reduce learned non-use of the hemiparetic arm in the days, and weeks immediately following stroke. We therefore restrict inclusion to stroke survivors in the inpatient rehabilitation unit of Froedtert Memorial Hospital (Milwaukee, WI). Thus, candidate subjects will undergo screening by Dr. McGuire and his team prior to inclusion in the study. Stroke survivors shall have: * had a unilateral stroke within the last 30 days; * ability to give informed consent and be able to follow two-stage instructions; * a broad range of motor impairment as assessed using the upper extremity portion of the Fugl-Meyer Motor Assessment (i.e., UE-FM score \<= 50 out of a possible 66); * age ≥ 18 yr. of age.
Exclusion criteria
(General) include: * Inability of subjects to give informed consent or follow two-stage instructions; * concurrent illness or severe pain limiting the capacity to conform to study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Average Activity Duration (RAAD) | During device use in an inpatient setting (about 1 to 3 weeks of use). | The RAAD assesses the amount of measured arm activity during cued exercise epochs compared to non-cued epochs. A RAAD value greater than 1.0 indicates that the amount of arm activity in response to Souvenir cues exceeded the amount of activity during non-cued periods of time. |
| System Usability Scale | Two time points: After device use in an inpatient setting (after about 1 to 3 weeks of use); after device use in home settings (after 2 days of use). | The System Usability Scale (SUS) assesses the usability of the activity cueing system and monitoring system within the context of encouraging therapeutic arm activity. Scores are provided on a scale ranging from 1 to 100, with higher scores indicating greater perceived usability. Scores greater than 68 are generally considered to indicate "passable" usability. |
| Intrinsic Motivation Inventory (IMI) | After device use in an inpatient setting (after about 1 to 3 weeks of use). | The IMI assesses subjective experience of motivation in response to the system's vibrotactile cues. IMI comprises 37 questions, with answers provided on a Likert scale (1-7). IMI questions span 6 psychosocial dimensions: * interest/enjoyment; higher scores = more interest/enjoyment with cued activities * effort/importance; higher scores = more perceived importance and more effort put into performing cued activities * value/usefulness higher scores = more perceived value and usefulness of cued activities * perceived choice; higher scores = greater degree to which participants felt that they had choice in engaging with the cued activities * perceived competence; higher scores = greater degree of competence performing cued activities * pressure/tension; higher scores = more anxiety/tension performing cued activities. A composite score is computed within each dimension by averaging item responses after reversing specified negative items; a score of 4 separates (+) from (-) experiences. |
| Quebec User Evaluation of Satisfaction With Technology (QUEST) | Two time points: After device use in an inpatient setting (after about 1 to 3 weeks of use); after device use in home settings (after 2 days of use). | The QUEST assesses user satisfaction with the system and its delivery by the research team.. The QUEST comprises 12 questions, with answers provided on a Likert scale (1-5). For each question, a score of "1" = not at all satisfied where "5" is "very satisfied". A composite score (min = 1; max = 5) is computed for the QUEST by averaging across all questions. A score of 3 separates (+) from (-) experiences. |
Countries
United States
Participant flow
Recruitment details
Recruitment dates: 11/29/2022 through 7/18/2023. Recruitment location: inpatient rehabilitation facility
Participants by arm
| Arm | Count |
|---|---|
| Survivors of Stroke in Early Stages of Recovery This was a single cohort study. We evaluated the feasibility, functional utility, and subjective user experience of a progressive-challenge cued activity program, delivered via wearable technology, to promote upper limb activity in an inpatient rehabilitation facility during the early days and weeks following stroke.
Quantitative movement data was collected using accelerometry (motion trackers worn on both wrists) to estimate compliance with the cue responses. We assessed user experience using validated quantitative surveys that measure motivation to engage with the system, perceptions of system usability, and the degree of user satisfaction while using the technology. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Survivors of Stroke in Early Stages of Recovery |
|---|---|
| Age, Continuous | 63.2 Years STANDARD_DEVIATION 14.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fugl-Meyer Upper Extremity Motor Score | 45.6 numerical score (ordinal) STANDARD_DEVIATION 25.1 |
| Fugl-Meyer Upper Extremity Sensory Score | 11.5 numerical score (ordinal) STANDARD_DEVIATION 1.7 |
| Montreal Cognitive Assessment (MoCA) | 25.9 numerical score (ordinal) STANDARD_DEVIATION 4.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
Intrinsic Motivation Inventory (IMI)
The IMI assesses subjective experience of motivation in response to the system's vibrotactile cues. IMI comprises 37 questions, with answers provided on a Likert scale (1-7). IMI questions span 6 psychosocial dimensions: * interest/enjoyment; higher scores = more interest/enjoyment with cued activities * effort/importance; higher scores = more perceived importance and more effort put into performing cued activities * value/usefulness higher scores = more perceived value and usefulness of cued activities * perceived choice; higher scores = greater degree to which participants felt that they had choice in engaging with the cued activities * perceived competence; higher scores = greater degree of competence performing cued activities * pressure/tension; higher scores = more anxiety/tension performing cued activities. A composite score is computed within each dimension by averaging item responses after reversing specified negative items; a score of 4 separates (+) from (-) experiences.
Time frame: After device use in an inpatient setting (after about 1 to 3 weeks of use).
Population: Of the 42 recruited participants, 12 withdrew or were withdrawn. Reasons for withdrawal included: disliking the vibrotactile cues after initial demonstration with the device (4), disliking the cues after 1-2 days of use (5), transfer of care to outside facility (1), complex therapy schedule (1), and physician withdraw (1).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Survivors of Stroke in Early Stages of Recovery | Intrinsic Motivation Inventory (IMI) | interest/enjoyment dimension | 4.9 units on a scale | Standard Deviation 1.3 |
| Survivors of Stroke in Early Stages of Recovery | Intrinsic Motivation Inventory (IMI) | effort/importance dimension | 5.4 units on a scale | Standard Deviation 1.4 |
| Survivors of Stroke in Early Stages of Recovery | Intrinsic Motivation Inventory (IMI) | value/usefulness dimension | 6.2 units on a scale | Standard Deviation 0.9 |
| Survivors of Stroke in Early Stages of Recovery | Intrinsic Motivation Inventory (IMI) | perceived choice dimension | 6.0 units on a scale | Standard Deviation 0.9 |
| Survivors of Stroke in Early Stages of Recovery | Intrinsic Motivation Inventory (IMI) | perceived competence dimension | 5.8 units on a scale | Standard Deviation 1.2 |
| Survivors of Stroke in Early Stages of Recovery | Intrinsic Motivation Inventory (IMI) | pressure/tension dimension | 2.8 units on a scale | Standard Deviation 1 |
Primary
Quebec User Evaluation of Satisfaction With Technology (QUEST)
The QUEST assesses user satisfaction with the system and its delivery by the research team.. The QUEST comprises 12 questions, with answers provided on a Likert scale (1-5). For each question, a score of 1 = not at all satisfied where 5 is very satisfied. A composite score (min = 1; max = 5) is computed for the QUEST by averaging across all questions. A score of 3 separates (+) from (-) experiences.
Time frame: Two time points: After device use in an inpatient setting (after about 1 to 3 weeks of use); after device use in home settings (after 2 days of use).
Population: Of the 42 recruited participants, 12 withdrew or were withdrawn. Reasons for withdrawal included: disliking the vibrotactile cues after initial demonstration with the device (4), disliking the cues after 1-2 days of use (5), transfer of care to outside facility (1), complex therapy schedule (1), and physician withdraw (1).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Survivors of Stroke in Early Stages of Recovery | Quebec User Evaluation of Satisfaction With Technology (QUEST) | QUEST post-device use in an inpatient setting | 4.52 units on a scale | Standard Deviation 0.46 |
| Survivors of Stroke in Early Stages of Recovery | Quebec User Evaluation of Satisfaction With Technology (QUEST) | QUEST after use in home settings | 4.5 units on a scale | Standard Deviation 0.5 |
Primary
Ratio of Average Activity Duration (RAAD)
The RAAD assesses the amount of measured arm activity during cued exercise epochs compared to non-cued epochs. A RAAD value greater than 1.0 indicates that the amount of arm activity in response to Souvenir cues exceeded the amount of activity during non-cued periods of time.
Time frame: During device use in an inpatient setting (about 1 to 3 weeks of use).
Population: Of the 42 recruited participants, 12 withdrew or were withdrawn. Reasons for withdrawal included: disliking the vibrotactile cues after initial demonstration with the device (4), disliking the cues after 1-2 days of use (5), transfer of care to outside facility (1), complex therapy schedule (1), and physician withdraw (1).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Survivors of Stroke in Early Stages of Recovery | Ratio of Average Activity Duration (RAAD) | 1.223 ratio | Standard Deviation 0.63 |
Primary
System Usability Scale
The System Usability Scale (SUS) assesses the usability of the activity cueing system and monitoring system within the context of encouraging therapeutic arm activity. Scores are provided on a scale ranging from 1 to 100, with higher scores indicating greater perceived usability. Scores greater than 68 are generally considered to indicate passable usability.
Time frame: Two time points: After device use in an inpatient setting (after about 1 to 3 weeks of use); after device use in home settings (after 2 days of use).
Population: Of the 42 recruited participants, 12 withdrew or were withdrawn. Reasons for withdrawal included: disliking the vibrotactile cues after initial demonstration with the device (4), disliking the cues after 1-2 days of use (5), transfer of care to outside facility (1), complex therapy schedule (1), and physician withdraw (1).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Survivors of Stroke in Early Stages of Recovery | System Usability Scale | SUS obtained after using the device in an inpatient setting | 80.1 units on a scale | Standard Deviation 13.8 |
| Survivors of Stroke in Early Stages of Recovery | System Usability Scale | SUS obtained after using the device in home settings | 83.3 units on a scale | Standard Deviation 15.2 |