StrokeNCT05420103
Research Proposal of New Technologies and Standardization of Physiotherapy Stroke Rehabilitation
An observational study of Stroke, run by Tai Po Hospital at 1 site in Hong Kong.
Trial summary
One of the main goals of physiotherapy in stroke rehabilitation is to maximize walking ability of patients as soon as possible. Traditionally, intervention selection and application of neuroplasticity to stroke patients depends on personal preference and experience of therapists. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Accelerated Stroke Ambulation Program
- How many people
- 650 participants
- Where
- 1 siteHong Kong
- Study dates
- 8 Jun 2022to 8 Jun 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia and had received has received physiotherapy gym session training in a hospital in Hong Kong between the periods from 1 October 2018 to 31 September 2019 and from 1 October 2020 to 31 September 2021.
Who may be able to join
- Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia and had received has received physiotherapy gym session training in a hospital in Hong Kong between the periods from 1 October 2018 to 31 September 2019 and from 1 October 2020 to 31 September 2021.
Who cannot join
- Transfer out of the hospital, discharged against medical advice or died.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research Proposal of New Technologies and Standardization of Physiotherapy Stroke Rehabilitation - A Retrospective Functional Outcomes Analysis of Accelerated Stroke Ambulation Program (ASAP)
One of the main goals of physiotherapy in stroke rehabilitation is to maximize walking ability of patients as soon as possible. Traditionally, intervention selection and application of neuroplasticity to stroke patients depends on personal preference and experience of therapists. Recent development of technologies may provide more accessible, efficient, objective, intensive and predictive methods compared to traditional practices in facilitating the process of recovery after brain injury and standardizing stroke rehabilitation programs.
A clinical quality improvement program named Accelerated Stroke Ambulation Program (ASAP) was started in Stroke Rehabilitation Program Tai Po Hospital by Physiotherapy Department since 2019, pilot period from October 2019 to September 2020 and execute as standard practice afterward.
Read the detailed description
The goal of ASAP was to facilitate maximal walking ability of stroke patients by standardized application of modern technologies. ASAP features standardized functional assessment, standardized intensive early ambulation with modern technologies such as Knee-Ankle-Foot Orthoses, Lower Limb Robotic-Assisted Gait Training and Video-Guide Training. In order to monitor the progress of each patient proactively, Stroke Registry and Reference Modified Rivermead Mobility Index (MRMI) Gain were developed. Stroke Registry was a longitudinal stroke rehabilitation database to monitor patients' functional outcome and therapists' intervention compliance. Reference MRMI Gain was a clinical prediction model based on big data concept to support goal-orientated approach of physiotherapists in stroke rehabilitation. Stroke treatment library, a standardized exercise prescription in video format was also developed to facilitate standardized prescription of interventions to patients with different level of ability.
- Conditions
- Stroke
- Being tested
- Accelerated Stroke Ambulation Program
- Keywords
- stroke, rehabilitation, physiotherapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Stroke Ambulation ProgramOther
Stroke Rehabilitation Program
| Study group | Role | What they receive |
|---|---|---|
| Pre-ASAP | Conventional Stroke Rehabilitation Program | |
| Post-ASAP | Standardized functional assessment, standardized intensive early ambulation with modern technologies such as Knee-Ankle-Foot Orthoses and Robotic-Assisted Gait Training. In order to monitor the progress of each patient proactively, Stroke Registry and Reference Modified Rivermead Mobility Index (MRMI) Gain were developed. Stroke Registry was a longitudinal stroke rehabilitation database to monitor patients' functional outcomes and therapists' intervention compliance so as to pave the way for future clinical big data movement to bridge the gap between evidence-practice and clinical practice. Reference MRMI Gain was a clinical prediction model apply business intelligence concept to support goal-orientated approach of physiotherapists in stroke rehabilitation. Stroke treatment library, a standardized exercise prescription in video format was also developed to facilitate standardized prescription of interventions to patients with different level of ability. Receives: Other: Accelerated Stroke Ambulation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rivermead Mobility Index
Modified Rivermead Mobility Index consists of eight test items, including turning over, changing from lying to sitting, maintaining sitting balance, going from sitting to standing, standing, transferring, walking indoors, and climbing stairs. The score of MRMI range from 0 to 40, the higher score the more independence in mobility.
Measured: The first day of assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start8 Jun 2022
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tai Po Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bryan Ping Ho CHUNG, Tai Po Hospital
- Investigators
- Bryan Ping Ho CHUNG, Principal investigator, Tai Po Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420103
- Sponsor's protocol ID
- NTEC-2022-0267
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Proposal of New Technologies and Standardization of Physiotherapy Stroke Rehabilitation - A Retrospective Functional Outcomes Analysis of Accelerated Stroke Ambulation Program (ASAP)
- ClinicalTrials.gov ID
- NCT05420103
- Acronym / sponsor ID
- NTEC-2022-0267
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, physiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Tai Po HospitalOther government
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 15 Jun 2022 (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.
One of the main goals of physiotherapy in stroke rehabilitation is to maximize walking ability of patients as soon as possible. Traditionally, intervention selection and application of neuroplasticity to stroke patients depends on personal preference and experience of therapists. Recent development of technologies may provide more accessible, efficient, objective, intensive and predictive methods compared to traditional practices in facilitating the process of recovery after brain injury and standardizing stroke rehabilitation programs.
A clinical quality improvement program named Accelerated Stroke Ambulation Program (ASAP) was started in Stroke Rehabilitation Program Tai Po Hospital by Physiotherapy Department since 2019, pilot period from October 2019 to September 2020 and execute as standard practice afterward.
Detailed description
The goal of ASAP was to facilitate maximal walking ability of stroke patients by standardized application of modern technologies. ASAP features standardized functional assessment, standardized intensive early ambulation with modern technologies such as Knee-Ankle-Foot Orthoses, Lower Limb Robotic-Assisted Gait Training and Video-Guide Training. In order to monitor the progress of each patient proactively, Stroke Registry and Reference Modified Rivermead Mobility Index (MRMI) Gain were developed. Stroke Registry was a longitudinal stroke rehabilitation database to monitor patients' functional outcome and therapists' intervention compliance. Reference MRMI Gain was a clinical prediction model based on big data concept to support goal-orientated approach of physiotherapists in stroke rehabilitation. Stroke treatment library, a standardized exercise prescription in video format was also developed to facilitate standardized prescription of interventions to patients with different level of ability.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-ASAP | – | –Conventional Stroke Rehabilitation Program |
| Post-ASAP | – | Other: Accelerated Stroke Ambulation ProgramStandardized functional assessment, standardized intensive early ambulation with modern technologies such as Knee-Ankle-Foot Orthoses and Robotic-Assisted Gait Training. In order to monitor the progress of each patient proactively, Stroke Registry and Reference Modified Rivermead Mobility Index (MRMI) Gain were developed. Stroke Registry was a longitudinal stroke rehabilitation database to monitor patients' functional outcomes and therapists' intervention compliance so as to pave the way for future clinical big data movement to bridge the gap between evidence-practice and clinical practice. Reference MRMI Gain was a clinical prediction model apply business intelligence concept to support goal-orientated approach of physiotherapists in stroke rehabilitation. Stroke treatment library, a standardized exercise prescription in video format was also developed to facilitate standardized prescription of interventions to patients with different level of ability. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia and had received has received physiotherapy gym session training in a hospital in Hong Kong between the periods from 1 October 2018 to 31 September 2019 and from 1 October 2020 to 31 September 2021.
Key inclusion criteria (1 listed)
- Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia and had received has received physiotherapy gym session training in a hospital in Hong Kong between the periods from 1 October 2018 to 31 September 2019 and from 1 October 2020 to 31 September 2021.
Key exclusion criteria (1 listed)
- Transfer out of the hospital, discharged against medical advice or died.
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 |
|---|---|---|
| Accelerated Stroke Ambulation ProgramStroke Rehabilitation Program | Other | Post-ASAP |
Primary outcome
Modified Rivermead Mobility Index
Time frame: The first day of assessment
Modified Rivermead Mobility Index consists of eight test items, including turning over, changing from lying to sitting, maintaining sitting balance, going from sitting to standing, standing, transferring, walking indoors, and climbing stairs. The score of MRMI range from 0 to 40, the higher score the more independence in mobility.
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 15 Jun 2022.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Bryan Ping Ho CHUNG principal investigator
Tai Po Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Tai Po Hospital at 1 site in Hong Kong.
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 1 inclusion and 1 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 15 Jun 2022. 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 Hong Kong. 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?
Modified Rivermead Mobility Index (time frame: The first day of assessment). 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 15 Jun 2022.