Acute Ischemic StrokeNCT04402736
Feasibility and Effectiveness of Rehabilitation Nursing for Acute Stroke
A study testing The modified Barthel Index-based rehabilitation nursing program in people with Acute Ischemic Stroke and Nursing, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
In the clinical setting, it is difficult to obtain effective rehabilitation during the acute phase, the reasons may include insufficient awareness of early rehabilitation due mainly to a limitation in number and variety of rehabilitation professionals in Low- and middle-income countries. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Ischemic Stroke, Nursing
- What is being tested?
- The modified Barthel Index-based rehabilitation nursing program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2018to 20 Nov 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with ischemic stroke and met the diagnostic criteria of the World Health Organization;
- initial stroke within seven days, with limb dysfunction;
- NIHSS scale consciousness scores of 0 or 1;
- provided informed consent form.
Who cannot join
- incomplete clinical data;
- having a physical disability or other diseases that affect the limb function;
- having cognitive impairment or other diseases that interfere with participation;
- having serious cardiopulmonary dysfunction or another disease that requires absolute bed rest;
- having progressive stroke or having severe complications that patients drop the study before completion.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: Feasibility and Effectiveness of a Modified Barthel Index-based Rehabilitation Nursing Program for Acute Ischemic Stroke
In the clinical setting, it is difficult to obtain effective rehabilitation during the acute phase, the reasons may include insufficient awareness of early rehabilitation due mainly to a limitation in number and variety of rehabilitation professionals in Low- and middle-income countries. It is necessary to shift tasks to other healthcare providers who are trained to provide rehabilitation like nurses. The purpose of this study is to examine the feasibility and effectiveness of a modified Barthel Index based rehabilitation nursing program on acute stroke inpatients.
Read the detailed description
Ischemic stroke is the main cause of disability in the world. More than 70% of stroke patients show various degrees of neural function impairment. Early rehabilitation in acute phase is beneficial for improving patient's activity of daily livings and motor function. However, it is difficult to obtain effective rehabilitation during the acute phase of stroke because of the insufficiency of professional rehabilitation therapists in stroke wards in China. The investigators assume that implementing program based on modified Barthel Index can realize nursing-directed motor rehabilitation during acute phase of ischemic stroke. The present study is to conduct quasi-experimental research to confirm the feasibility and effectiveness of nursing-directed precision rehabilitation in acute stroke patients.
- Conditions
- Acute Ischemic Stroke, Nursing
- Being tested
- The modified Barthel Index-based rehabilitation nursing program, Usual care
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The modified Barthel Index-based rehabilitation nursing programBehavioural
The intervention with the program based on the MBI classified function of patients into five levels, with every 20 points as a level, Each level corresponds to different training items. Training items included self-care training and training in transfer activities, sitting balance, walking, and sit-to-stand, etc. Each training session lasting at least 30 minutes, two sessions per day, for seven continuous days. During the intervention, the rehabilitation therapist's conventional treatment is not interfered.
Usual careBehavioural
Patients in the control group received clinical usual care including the activities of daily living assessment, early mobilization guide and health education. During the intervention, the rehabilitation therapist's conventional treatment is not interfered.
| Study group | Role | What they receive |
|---|---|---|
| Modified Barthel Index-based rehabilitation nursing program | Experimental | Patients received the Modified Barthel Index based rehabilitation nursing from qualified nurses. Receives: Behavioral: The modified Barthel Index-based rehabilitation nursing program |
| Usual care | Other | Patients received the usual care. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline the Modified Barthel Index (MBI) on day 7
The MBI score ranges from 0 to 100, the higher scores mean a better outcome.
Measured: Day 0 and day 7
Change from baseline the motor assessment scale (MAS) on day 7
The MAS scale excluding general tonus, may be summed to provide an overall score out of a possible 48 points and the higher scores mean a better outcome.
Measured: Day 0 and day 7
Change from baseline the National Institute of Health Stroke Scale (NIHSS) on day 7
The NIHSS scale ranges from 0 to 42, and the higher scores mean a worse outcome.
Measured: Day 0 and day 7
Secondary outcomes (2)
The completion rate
The completion means participants completed all the study stage and all the data collection.
Measured: Day 7
The adverse events rate
The adverse events including pneumonia, stroke progression or recurrent, fall.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start4 Jan 2018
- Primary completion29 Oct 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingfen Jin, Master, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402736
- Sponsor's protocol ID
- 2018LS112
- Status last verified
- May 2020
- First submitted
- 16 May 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of a Modified Barthel Index-based Rehabilitation Nursing Program for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04402736
- Acronym / sponsor ID
- 2018LS112
- Conditions
- Acute Ischemic Stroke, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 27 May 2020 (actual)
- 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.
In the clinical setting, it is difficult to obtain effective rehabilitation during the acute phase, the reasons may include insufficient awareness of early rehabilitation due mainly to a limitation in number and variety of rehabilitation professionals in Low- and middle-income countries. It is necessary to shift tasks to other healthcare providers who are trained to provide rehabilitation like nurses. The purpose of this study is to examine the feasibility and effectiveness of a modified Barthel Index based rehabilitation nursing program on acute stroke inpatients.
Detailed description
Ischemic stroke is the main cause of disability in the world. More than 70% of stroke patients show various degrees of neural function impairment. Early rehabilitation in acute phase is beneficial for improving patient's activity of daily livings and motor function. However, it is difficult to obtain effective rehabilitation during the acute phase of stroke because of the insufficiency of professional rehabilitation therapists in stroke wards in China. The investigators assume that implementing program based on modified Barthel Index can realize nursing-directed motor rehabilitation during acute phase of ischemic stroke. The present study is to conduct quasi-experimental research to confirm the feasibility and effectiveness of nursing-directed precision rehabilitation in acute stroke patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Barthel Index-based rehabilitation nursing program | Experimental | Behavioral: The modified Barthel Index-based rehabilitation nursing programPatients received the Modified Barthel Index based rehabilitation nursing from qualified nurses. |
| Usual care | Other | Behavioral: Usual carePatients received the usual care. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with ischemic stroke and met the diagnostic criteria of the World Health Organization;
- initial stroke within seven days, with limb dysfunction;
- NIHSS scale consciousness scores of 0 or 1;
- provided informed consent form.
Key exclusion criteria (5 listed)
- incomplete clinical data;
- having a physical disability or other diseases that affect the limb function;
- having cognitive impairment or other diseases that interfere with participation;
- having serious cardiopulmonary dysfunction or another disease that requires absolute bed rest;
- having progressive stroke or having severe complications that patients drop the study before completion.
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 |
|---|---|---|
| The modified Barthel Index-based rehabilitation nursing programThe intervention with the program based on the MBI classified function of patients into five levels, with every 20 points as a level, Each level corresponds to different training items. Training items included self-care training and training in transfer activities, sitting balance, walking, and sit-to-stand, etc. Each training session lasting at least 30 minutes, two sessions per day, for seven continuous days. During the intervention, the rehabilitation therapist's conventional treatment is not interfered. | Behavioural | Modified Barthel Index-based rehabilitation nursing program |
| Usual carePatients in the control group received clinical usual care including the activities of daily living assessment, early mobilization guide and health education. During the intervention, the rehabilitation therapist's conventional treatment is not interfered. | Behavioural | Usual care |
Primary outcome
Change from baseline the Modified Barthel Index (MBI) on day 7
Time frame: Day 0 and day 7
The MBI score ranges from 0 to 100, the higher scores mean a better outcome.
Change from baseline the motor assessment scale (MAS) on day 7
Time frame: Day 0 and day 7
The MAS scale excluding general tonus, may be summed to provide an overall score out of a possible 48 points and the higher scores mean a better outcome.
Change from baseline the National Institute of Health Stroke Scale (NIHSS) on day 7
Time frame: Day 0 and day 7
The NIHSS scale ranges from 0 to 42, and the higher scores mean a worse outcome.
2 secondary outcomes
The completion rate
Time frame: Day 7
The adverse events rate
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
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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.
Jingfen Jin, Master study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The modified Barthel Index-based rehabilitation nursing program in people with Acute Ischemic Stroke and Nursing, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 12 Nov 2020. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline the Modified Barthel Index (MBI) on day 7 (time frame: Day 0 and day 7). The study lists 3 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 12 Nov 2020.