StrokeNCT01891565
Stroke Inpatients Rehabilitation Reinforcement of Activity
A study testing Feedback in people with Stroke, run by University of Ibadan at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNigeria
- Study dates
- Jul 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mayowa O Owolabi contact
T K Hamzat contact
About this study
Official title: Stroke Inpatients Rehabilitation With Accelerometer-based Feedback Reinforcement of Activity
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:
Read more
- 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.
- Conditions
- Stroke
- Being tested
- Feedback
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeedbackBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Activity Feedback | Experimental | Feedback Receives: Behavioral: Feedback |
| No Feedback | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in walking speed
Measured: Baseline, Two weeks, Discharge, 1 month
Change in Health-Related Quality of Life as measured using HRQOLISP-26
Measured: Baseline, Two weeks, Discharge, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ibadan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mayowa Owolabi, University of Ibadan
- Investigators
- Mayowa O Owolabi, Principal investigator, University of Ibadan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891565
- Sponsor's protocol ID
- 2013-001
- Status last verified
- Jun 2013
- First submitted
- 26 Jun 2013
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Inpatients Rehabilitation With Accelerometer-based Feedback Reinforcement of Activity
- ClinicalTrials.gov ID
- NCT01891565
- Acronym / sponsor ID
- 2013-001
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of IbadanUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity Feedback | Experimental | Behavioral: FeedbackFeedback |
| No Feedback | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feedback | Behavioural | Activity Feedback |
Primary outcome
Change in walking speed
Time frame: Baseline, Two weeks, Discharge, 1 month
Change in Health-Related Quality of Life as measured using HRQOLISP-26
Time frame: Baseline, Two weeks, Discharge, 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayowa O Owolabi contact
T K Hamzat contact
Mayowa O Owolabi principal investigator
University of Ibadan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback in people with Stroke, run by University of Ibadan at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mayowa O Owolabi (mayowaowolabi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in walking speed (time frame: Baseline, Two weeks, Discharge, 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.