Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
Change scores in Fugl-Meyer Assessment from baseline to discharge and baseline to follow-up |
FMA is a valid and reliable UE assessment to measure motor impairment in stroke. It consists of 33 items reflecting typical shoulder and hand motions in and out of synergy patterns characteristic of motor recovery after stroke. It is the gold standard performance-based assessment in UE stroke rehabilitation with an established minimal clinically important difference (MCID) of 4.25-7.25 points for chronic stroke patients. |
Day 4 visit, Day 37-39 visit, Day 65-67 visit |
|
Secondary |
Change scores in Motor Activity Log from baseline to discharge and baseline to follow-up |
Motor Activity Log (MAL) is a valid and reliable self-report questionnaire for individuals in the subacute and chronic phase after stroke. Originally created as the primary outcome for Constraint Induced Movement Therapy, the MAL captures spontaneous use of the affected UE in daily life. It consists of 28 items reflecting basic and instrumental activities of daily living items. Scoring is based on an ordinal scale ranging from 1-5, and final scores are determined by calculating the mean of all item scores. This study will use the amount of use subscale for this study. |
Day 4 visit, Day 37-39 visit, Day 65-67 visit |
|
Secondary |
Change scores in Canadian Occupational Performance Measure from baseline to discharge and baseline to follow-up |
The Canadian Occupational Performance Measure (COPM) is a valid and reliable individualized self-report measure that quantifies a participants' perception of everyday performance. Participants rate their change in their performance and satisfaction on a scale of 1 (unable to perform/not satisfied) to 10 (able to perform, extremely satisfied). A change of two or more points is considered clinically significant. |
Day 4 visit, Day 37-39 visit, Day 65-67 visit |
|
Secondary |
Change scores in UE accelerometry data calculated using bilateral magnitude ratio from baseline to discharge and baseline to follow-up. |
Wrist worn accelerometers can be used to provide objective, valid, and reliable data on general UE motion in home settings. As a secondary outcome for adherence, we will collect bilateral UE accelerometry data continuously for 24 hours at all timepoints to determine if there are any changes in UE motion of the affected side in relation to the unaffected side before and after the intervention. Commercially available Actigraph GT9X Link wrist sensors will be used to collect bilateral UE motion at baseline, discharge, and follow up. |
Day 4 visit, Day 37-39 visit, Day 65-67 visit |
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