Stroke Inpatient Rehabilitation Reinforcement of ACTivity
Completed · Phase 3
Conditions studied: Stroke
In brief
The purpose of this study is to determine the effects of daily feedback about physical activity (number of bouts of walking, duration of bouts, total walking distance, average and fastest walking speed) and walking average speed compared to feedback about walking speed only on walking-related outcomes during inpatient rehabilitation for stroke. For the first time, daily walking and other exercise will be monitored by bilateral triaxial accelerometers on the ankles. Activity-recognition algorithms will analyze the inpatient sensor data and return a summary to the participants at each site.
Key facts
- Study ID
- NCT01246882
- Run by
- University of California, Los Angeles
- People needed
- 140
- Starts
- 2011-01-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2019-05-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Fairlawn Hospital — Worcester, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Washington University — St Louis, Missouri, United States
- Burke Rehabilitation Hospital — White Plains, New York, United States
- St. Luke's Hospital — Allentown, Pennsylvania, United States
- Ain Shams University — Cairo, Egypt
- Father Muller Medical College — Karnataka, India
- National Rehabilitation Hospital — Dublin, Ireland
- San Raffaele Hospital — Milan, Italy
- Sam Camillo — Venice, Italy
- Morinomiya Hospital — Osaka, Japan
- Burwood Hospital — Christchurch, New Zealand
- Univeristy College Hospital — Ibadan, Nigeria
- Chonnam National Hospital — Gwangju, South Korea
- Rehabilitation Hospital — Barcelona, Spain
- University of Vigo — Vigo, Spain
- National Taiwan University Hospital — Taipei, Taiwan
- Gazi University — Ankara, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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