NIMI-NICU: Non Invasive Monitoring of the Intracranial Pressure - NeuroIntensive Care Unit
NCT01685476
Brain Diseases, Brain Injuries
Clermont-Ferrand, France
View Trial DetailsNCT Number: NCT07557940
The investigators want to objectively measure, through the use of accelerometers, the time, movement intensity, and bilaterality of Upper Extremity (UE) activity and see if these improve over the course of therapy.
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Notify Me18 year and older
All sexes
Observational
Occupational therapists utilize a battery of standardized assessments at evaluation and throughout the duration of services. These performance-based assessments measure abilities at impairment and activity levels (e.g. grip strength and the Action Research Arm Test). The assumption is made that improved performance on these in-clinic assessments correlates to increased UE activity outside the clinic in daily life. This assumption however, is unsupported by current evidence. Currently, self report measures (e.g. Stroke Impact Scale, Motor Activity Log) are used in both clinical and research settings to gather data on activity outside of therapy time. These measures however, are subject to bias, particularly for physical activity. Social desirability, or the tendency of individuals to portray themselves in keeping up with norms, has been linked specifically to the bias of self report measures. It was found that durations of light and moderate activity were over reported by as much as 79 min/day. These numbers indicate that participants tend to overestimate the amount of activity throughout their day in order to please their provider according to their perceived acceptable norms.
In recent years, accelerometry has been established as an objective, unbiased tool for measuring real world UE activity. Accelerometers have been used to track UE activity in the inpatient rehabilitation setting and then compared to healthy controls. This comparison indicated that healthy individuals use their dominant and non-dominant arms 8-9 hours per day. Individuals with stroke demonstrate significantly less UE use; using their affected arm approximately 3.3 hours and their unaffected arm 6.0 hours per day. A recent study with community dwelling healthy individuals confirmed that healthy individuals use their dominant hand 9 hours and their non-dominant hand 8.6 hours per day. These newer data indicate that regardless of dominance, patients post stroke use their affected limb significantly less than healthy individuals in the community.
Using the framework from previous accelerometry studies, the proposed research study will address the critical need to understand real world UE activity in stroke survivors undergoing standard outpatient occupational therapy. The investigators want to objectively measure, through the use of accelerometers, the time, movement intensity, and bilaterality of UE activity and see if these improve over the course of therapy. These data will help clinicians understand actual UE usage during everyday activities outside of prescribed therapy time. Clinicians will be able to tell if the interventions they are providing are increasing activity in the real world, and not just increasing patient performance in the clinic.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: change from baseline to post 30 days, and discharge from inpatient hospitalization up to 12 weeks)
the ARAT, two sections of the Stroke Impact Scale will be administered via interview format. The two sections (hand and participation in activities at home) will capture each subject's perceived participation related to UE activity.
Time frame: change from baseline at time of enrollment to post 30 days, and discharge from inpatient hospitalization (up to 12 weeks)
Two sections of the Stroke Impact Scale will be administered via interview format. The two sections (hand and participation in activities at home) will capture each subject's perceived participation related to UE activity.
Time frame: change from baseline at time of enrollment to post 30 days, and discharge from inpatient hospitalization (up to 12 weeks)
The accelerometers track UE movement along three axes. Data are recorded as a time-series of numbers (in activity counts, where 1 count = 0.016318 g), collected every second over the 24-48 hour wearing period. The second outcome is counts (number of repetitions)
Shirley Ryan AbilityLab
Other
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