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Trial record 2 of 2 for:    SIRRACT

Stroke Inpatients Rehabilitation Reinforcement of Activity

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by University of Ibadan
Sponsor:
Information provided by (Responsible Party):
Dr. Mayowa Owolabi, University of Ibadan
ClinicalTrials.gov Identifier:
NCT01891565
First received: June 26, 2013
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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 Intervention
Stroke
Behavioral: Feedback

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Ibadan:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
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)
Arms Assigned Interventions
Experimental: Activity Feedback
Feedback
Behavioral: Feedback
No Intervention: No Feedback

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891565

Contacts
Contact: Mayowa O Owolabi mayowaowolabi@yahoo.com
Contact: T K Hamzat talkzat@yahoo.com

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

No publications provided

Responsible Party: Dr. Mayowa Owolabi, Consultant Neurologist, University of Ibadan
ClinicalTrials.gov Identifier: NCT01891565     History of Changes
Other Study ID Numbers: 2013-001
Study First Received: June 26, 2013
Last Updated: June 28, 2013
Health Authority: Nigeria: The National Agency for Food and Drug Administration and Control

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014