Stroke Inpatients Rehabilitation Reinforcement of Activity
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Feedback
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke
Eligibility 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.
Sites / Locations
- University College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Activity Feedback
No Feedback
Arm Description
Feedback
Outcomes
Primary Outcome Measures
Change in walking speed
Change in Health-Related Quality of Life as measured using HRQOLISP-26
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01891565
Brief Title
Stroke Inpatients Rehabilitation Reinforcement of Activity
Official Title
Stroke Inpatients Rehabilitation With Accelerometer-based Feedback Reinforcement of Activity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ibadan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Activity Feedback
Arm Type
Experimental
Arm Description
Feedback
Arm Title
No Feedback
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Feedback
Primary Outcome Measure Information:
Title
Change in walking speed
Time Frame
Baseline, Two weeks, Discharge, 1 month
Title
Change in Health-Related Quality of Life as measured using HRQOLISP-26
Time Frame
Baseline, Two weeks, Discharge, 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mayowa O Owolabi
Email
mayowaowolabi@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
T K Hamzat
Email
talkzat@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mayowa O Owolabi
Organizational Affiliation
University of Ibadan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College Hospital
City
Ibadan
State/Province
Oyo
Country
Nigeria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mayowa O Owolabi
12. IPD Sharing Statement
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Stroke Inpatients Rehabilitation Reinforcement of Activity
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