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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01246882 |
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Date of registration:
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22/11/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Stroke Inpatient Rehabilitation Reinforcement of ACTivity
SIRRACT |
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Scientific title:
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Stroke Inpatient Rehabilitation Reinforcement of ACTivty: An International Multisite Clinical Trial |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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140 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01246882 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Egypt
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India
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Ireland
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Italy
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Japan
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Korea, Republic of
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New Zealand
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Nigeria
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Spain
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Taiwan
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Turkey
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United States
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Contacts
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Name:
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Bruce H Dobkin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, Los Angeles |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Admission for acute inpatient rehabilitation of a first stroke (or second stroke after
full recovery from prior TIA/Stroke)
- Time from onset of stroke to admission for rehabilitation < 35 days
- Stroke from any cause (thrombotic infarct, cardioembolus, intracerebral hemorrhage)
that includes unilateral hemiparesis. Hemiparesis means less than / equal to 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 / equal to 22 of 25 possible
points)
- Ability to follow simple instructions, especially to understand verbal reinforcement
about activity.
- Independent in mobility prior to admission by the Barthel Index.
- Able to walk with no more than physical assistance of 2 persons for at least 5 steps
(for example, 3 strides of the left leg alternating with 2 on the right leg). Subjects
can use any type of assistive device and brace needed.
- Able to understand and repeat information related to the Informed Consent. The subject
signs a Consent form.
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, DVT, 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 < 75% accuracy related to personal health and
symptoms.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Stroke
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Intervention(s)
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Behavioral: Augmented activity feedback
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Behavioral: Speed-only feedback
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Primary Outcome(s)
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Gait speed
[Time Frame: Discharge]
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Secondary Outcome(s)
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Distance walked in 3 minutes
[Time Frame: Discharge]
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Secondary ID(s)
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10-000134
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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