Trial record 2 of 2 for:    SIRRACT

Stroke Inpatients Rehabilitation Reinforcement of Activity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01891565
Recruitment Status : Unknown
Verified June 2013 by Dr. Mayowa Owolabi, University of Ibadan.
Recruitment status was:  Not yet recruiting
First Posted : July 3, 2013
Last Update Posted : July 3, 2013
Information provided by (Responsible Party):
Dr. Mayowa Owolabi, University of Ibadan

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Feedback Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Stroke Inpatients Rehabilitation With Accelerometer-based Feedback Reinforcement of Activity
Study Start Date : July 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Activity Feedback
Behavioral: Feedback
No Intervention: No Feedback

Primary Outcome Measures :
  1. Change in walking speed [ Time Frame: Baseline, Two weeks, Discharge, 1 month ]
  2. Change in Health-Related Quality of Life as measured using HRQOLISP-26 [ Time Frame: Baseline, Two weeks, Discharge, 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Admission for acute inpatient neurorehabilitation of a first stroke (or second stroke after full recovery from prior Transient Ischemic Attack/Stroke).
  • Time from onset of stroke to admission for rehabilitation <35 days.
  • Stroke from any cause (thrombotic infarct, cardioembolism, intracerebral hemorrhage) that includes unilateral hemiparesis. Hemiparesis means less than or equal 4/5 strength by the British Medical Council scale for hip flexion tested supine and for knee or ankle flexion and extension (scores less than or equal 22 of 25)
  • Ability to follow simple instructions, especially to understand verbal reinforcement about activity.
  • Independent in mobility prior to admission.
  • Able to walk with no more than physical assistance of 2 persons for at least 3 meters. Subjects can use any type of assistive device and brace needed.
  • Able to understand and repeat information related to the Informed Consent

Exclusion Criteria:

  • Current medical disease that will limit physical therapy at the time of randomization or limited walking prior to the stroke, such as serious infection, Deep Vein Thrombosis, orthostatic hypotension, > stage 2 decubitus ulcer of buttocks or legs, congestive heart failure, claudication, and pain with weight-bearing or walking. Subjects can be entered if a complication resolves within 7 days of admission screening.
  • Aphasia with inability to follow 2-step directions during therapeutic instructions or answers Yes/No to questions with greater than or equal 75% accuracy related to personal health and symptoms.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01891565

Contact: Mayowa O Owolabi
Contact: T K Hamzat

University College Hospital Not yet recruiting
Ibadan, Oyo, Nigeria
Principal Investigator: Mayowa O Owolabi         
Sponsors and Collaborators
University of Ibadan
Principal Investigator: Mayowa O Owolabi University of Ibadan

Responsible Party: Dr. Mayowa Owolabi, Consultant Neurologist, University of Ibadan Identifier: NCT01891565     History of Changes
Other Study ID Numbers: 2013-001
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases