Stroke Inpatients Rehabilitation Reinforcement of Activity
Recruitment status was Not yet recruiting
The amount of active therapy provided to patients on an inpatient stroke rehabilitation unit has been reported as often insufficient. Observational studies have found that in the first 14 days post stroke, patients receive very little therapy and have very low activity levels. More opportunity to practice may, however, improve short-term outcomes such as the level of mobility, endurance, use of the affected arm and leg, and length of stay. The Stroke Inpatient Rehabilitation Reinforcement of ACTivity (SIRRACT) trial will utilize sensors that reveal the type, quantity, and aspects of quality of patient activities outside of the confines of research laboratories. SIRRACT will deploy inexpensive Personal Activity Monitors (PAMs), comprised of triaxial accelerometers worn on the thighs.
The objectives of the study are:
i. To assess the impact of feedback from Personal Activity Monitors (PAM)s on amount of active practice, walking speed and distance in stroke patients undergoing rehabilitation.
ii. To assess the impact of feedback from PAMs on physical, psycho-emotional, cognitive and ecosocial Health-Related Quality of Life of stroke patients undergoing rehabilitation.
iii. To assess the acceptability of thigh-strapped accelerometer use among stroke patients undergoing rehabilitation.
iv. To assess the reliability and validity of thigh-strapped accelerometer use among stroke patients undergoing rehabilitation.
Hypotheses In moderate to severely disabled subjects who are receiving in-patient rehabilitation, daily feedback from PAMs about purposeful activity will increase the amount of active practice by >30%, a higher proportion of subjects who reach the level of independence for walking, and increase walking speed by 25%, leading to higher mean walking speeds and distances at the time of discharge from inpatient rehabilitation. Daily feedback from PAMs on increase in walking speed and distances will improve physical, psychological, cognitive and ecosocial domains of Health-related quality of life.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Stroke Inpatients Rehabilitation With Accelerometer-based Feedback Reinforcement of Activity|
- Change in walking speed [ Time Frame: Baseline, Two weeks, Discharge, 1 month ] [ Designated as safety issue: No ]
- Change in Health-Related Quality of Life as measured using HRQOLISP-26 [ Time Frame: Baseline, Two weeks, Discharge, 1 month ] [ Designated as safety issue: No ]
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Activity Feedback
|No Intervention: No Feedback|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01891565
|Contact: Mayowa O Owolabifirstname.lastname@example.org|
|Contact: T K Hamzatemail@example.com|
|University College Hospital||Not yet recruiting|
|Ibadan, Oyo, Nigeria|
|Principal Investigator: Mayowa O Owolabi|
|Principal Investigator:||Mayowa O Owolabi||University of Ibadan|