StrokeNCT02361307
The Outcomes of Seamless ADL Training Between Occupational Therapist and Nurse in Stroke Patients
A study testing Seamless ADL training and Conventional ADL training in people with Stroke, run by Mahidol University at 1 site in Thailand.
Trial summary
This study aimed to develop and implement an interdisciplinary team model with integration of all the relevant expertise and to establish powerful collaboration and communication among the team. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Seamless ADL training and Conventional ADL training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2015to Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First attack of stroke
- Good sitting balance
- TMSE 24 or more
- Need help in dresssing and bathing
Who cannot join
- Bilateral hemiparesis
- Dependent ADL before stroke attack
- Dementia
- Depression
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to develop and implement an interdisciplinary team model with integration of all the relevant expertise and to establish powerful collaboration and communication among the team. To this extent, we designed a new approach toward self-care training called the "seamless self-care training" technique, which involves enhanced coordination and communication between OTs and nurses in the rehabilitation ward to promote interdisciplinary cooperation in self-care training.
Read the detailed description
Rehabilitation is mandatory to promote functional recovery and minimize the distress of stroke survivors as much as possible. Even though rehabilitation outcomes are expected in all aspects, in one study the highest improvements were observed for bowel and bladder functions, transfer, and mobility, while the lowest improvements were seen in bathing (washing oneself), grooming (caring of body parts), dressing, and stair climbing.
Occupational therapists (OTs) are responsible for assessing and teaching skills to facilitate patients' activities and participation, including maximizing their performance of ADLs, and provide training programs and techniques that are tailor-made for each individual's impairment using targeted task-specific training, which has been acknowledged as the most effective method for enhancing functional outcomes. Nevertheless, the most important key factor for successful training outcomes is the collaboration of multiple healthcare professionals. All team members, especially nurses who spend lots of time with patients, should focus on encouraging and facilitating patients in transferring the newly relearned skills from professionals into their lives. Unfortunately, each expert usually approaches the patients from their own aspects, causing a lack of team perspective that could potentially preclude the patients from achieving their rehabilitation goals.
In current inpatient rehabilitation practice, there is still a gap in carrying out self-care training. Self-care training is usually carried out by OTs at the occupational therapy unit, whereas nursing staff assists washing and dressing the patients during admission at the rehabilitation ward. Due to time constraints, nurses usually concentrate on preparing the patients to be ready on time for other specific training. This hinders them from allowing patients the time and opportunity to practice by themselves, resulting in patients' having low confidence and a perception of low self-efficacy. Consequently, some patients may not develop sufficient skills to perform self-care independently after discharge. This situation was reported by Pryor and Long that an integrative function of nurses and other professionals was sub-optimal.
Therefore, in the present study, we aimed to develop and implement an interdisciplinary team model with integration of all the relevant expertise and to establish powerful collaboration and communication among the team. To this extent, we designed a new approach toward self-care training called the "seamless self-care training" technique, which involves enhanced coordination and communication between OTs and nurses in the rehabilitation ward to promote interdisciplinary cooperation in self-care training. We hope that this technique could make therapeutic intervention more successful and fill the gap in treatment processes, as well as to increase the self-efficacies of stroke survivors. The objective of this study was to explore the outcomes of providing this seamless self-care training to stroke patients.
- Conditions
- Stroke
- Being tested
- Seamless ADL training, Conventional ADL training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seamless ADL trainingProcedure or surgery
The experimental group receive the seamless ADL training which occupational therapist and nurse work with effective communication and cooperate in dressing and bathing training
Conventional ADL trainingProcedure or surgery
The control group receive the conventional ADL training programme
| Study group | Role | What they receive |
|---|---|---|
| conventional ADL training | Placebo comparator | The control group receive the conventional ADL training programme Receives: Procedure: Conventional ADL training |
| seamless ADL training | Active comparator | The experimental group receive the seamless ADL training programme which occupational therapist and nurse work with effective communication and cooperate in dressing and bathing training. Receives: Procedure: Seamless ADL training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of Dressing and Bathing
Normalized gain
The raw score from the self-care checklist for dressing and washing oneself was used to calculate the normalized gain. Because stroke patients had varying scores for their initial dressing and washing oneself abilities, their possible window of improvement could be limited by the "floor to ceiling" effect. Therefore, it was considered that their improvements should be assessed by the normalized gain, which was introduced by Hake as a rough measure of the effectiveness of a training course and has since become the standard method for reporting scores. Hake defined normalized gain (g) as the ratio of the actual gain to the maximum possible gain as given in the equation:
Normalized gain (g) = (post-training) - (pre-training) / (maximum score) - (pre-training) With a possible value between 0.0-1.0, the normalized gain can be divided into 3 levels: ''high-g'' for g ≥ 0.7, ''medium-g'' for 0.3 ≤ g ˂0.7, and ''low-g'' for g ˂ 0.3 The higher score means a better outcome.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Poungkaew Thitisakulchai, Mahidol University
- Investigators
- Poungkaew Thitisakulchai, MD, Principal investigator, Department of Rehabilitation Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361307
- Sponsor's protocol ID
- Si 644/2014
- Status last verified
- Jul 2021
- First submitted
- 28 Jan 2015
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcomes of Seamless ADL Training Between Occupational Therapist and Nurse in Stroke Patients
- ClinicalTrials.gov ID
- NCT02361307
- Acronym / sponsor ID
- Si 644/2014
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Posted 10 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to develop and implement an interdisciplinary team model with integration of all the relevant expertise and to establish powerful collaboration and communication among the team. To this extent, we designed a new approach toward self-care training called the "seamless self-care training" technique, which involves enhanced coordination and communication between OTs and nurses in the rehabilitation ward to promote interdisciplinary cooperation in self-care training.
Detailed description
Rehabilitation is mandatory to promote functional recovery and minimize the distress of stroke survivors as much as possible. Even though rehabilitation outcomes are expected in all aspects, in one study the highest improvements were observed for bowel and bladder functions, transfer, and mobility, while the lowest improvements were seen in bathing (washing oneself), grooming (caring of body parts), dressing, and stair climbing.
Occupational therapists (OTs) are responsible for assessing and teaching skills to facilitate patients' activities and participation, including maximizing their performance of ADLs, and provide training programs and techniques that are tailor-made for each individual's impairment using targeted task-specific training, which has been acknowledged as the most effective method for enhancing functional outcomes. Nevertheless, the most important key factor for successful training outcomes is the collaboration of multiple healthcare professionals. All team members, especially nurses who spend lots of time with patients, should focus on encouraging and facilitating patients in transferring the newly relearned skills from professionals into their lives. Unfortunately, each expert usually approaches the patients from their own aspects, causing a lack of team perspective that could potentially preclude the patients from achieving their rehabilitation goals.
In current inpatient rehabilitation practice, there is still a gap in carrying out self-care training. Self-care training is usually carried out by OTs at the occupational therapy unit, whereas nursing staff assists washing and dressing the patients during admission at the rehabilitation ward. Due to time constraints, nurses usually concentrate on preparing the patients to be ready on time for other specific training. This hinders them from allowing patients the time and opportunity to practice by themselves, resulting in patients' having low confidence and a perception of low self-efficacy. Consequently, some patients may not develop sufficient skills to perform self-care independently after discharge. This situation was reported by Pryor and Long that an integrative function of nurses and other professionals was sub-optimal.
Therefore, in the present study, we aimed to develop and implement an interdisciplinary team model with integration of all the relevant expertise and to establish powerful collaboration and communication among the team. To this extent, we designed a new approach toward self-care training called the "seamless self-care training" technique, which involves enhanced coordination and communication between OTs and nurses in the rehabilitation ward to promote interdisciplinary cooperation in self-care training. We hope that this technique could make therapeutic intervention more successful and fill the gap in treatment processes, as well as to increase the self-efficacies of stroke survivors. The objective of this study was to explore the outcomes of providing this seamless self-care training to stroke patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional ADL training | Placebo comparator | Procedure: Conventional ADL trainingThe control group receive the conventional ADL training programme |
| seamless ADL training | Active comparator | Procedure: Seamless ADL trainingThe experimental group receive the seamless ADL training programme which occupational therapist and nurse work with effective communication and cooperate in dressing and bathing training. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First attack of stroke
- Good sitting balance
- TMSE 24 or more
- Need help in dresssing and bathing
Key exclusion criteria (4 listed)
- Bilateral hemiparesis
- Dependent ADL before stroke attack
- Dementia
- Depression
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 |
|---|---|---|
| Seamless ADL trainingThe experimental group receive the seamless ADL training which occupational therapist and nurse work with effective communication and cooperate in dressing and bathing training | Procedure or surgery | seamless ADL training |
| Conventional ADL trainingThe control group receive the conventional ADL training programme | Procedure or surgery | conventional ADL training |
Primary outcome
Ability of Dressing and Bathing
Time frame: 2 weeks
Normalized gain The raw score from the self-care checklist for dressing and washing oneself was used to calculate the normalized gain. Because stroke patients had varying scores for their initial dressing and washing oneself abilities, their possible window of improvement could be limited by the "floor to ceiling" effect. Therefore, it was considered that their improvements should be assessed by the normalized gain, which was introduced by Hake as a rough measure of the effectiveness of a training course and has since become the standard method for reporting scores. Hake defined normalized gain (g) as the ratio of the actual gain to the maximum possible gain as given in the equation: Normalized gain (g) = (post-training) - (pre-training) / (maximum score) - (pre-training) With a possible value between 0.0-1.0, the normalized gain can be divided into 3 levels: ''high-g'' for g ≥ 0.7, ''medium-g'' for 0.3 ≤ g ˂0.7, and ''low-g'' for g ˂ 0.3 The higher score means a better outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Poungkaew Thitisakulchai, MD principal investigator
Department of Rehabilitation 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 Seamless ADL training and Conventional ADL training in people with Stroke, run by Mahidol University at 1 site in Thailand.
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 4 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 10 Aug 2021. 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 Thailand. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 10 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ability of Dressing and Bathing (time frame: 2 weeks). 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 10 Aug 2021.