Intra-arterial ThrombectomyNCT05764278
The Efficacy and Safety of Early Rehabilitation in Large Vessel Occlusion Patients After Intra-arterial Thrombectomy: A Prospective Randomized Controlled Trial
A study testing exercise in people with Intra-arterial Thrombectomy, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
Trial summary
Early rehabilitation is feasible for stroke patients is still under debate. In addition, IA thrombectomy has been a new treatment for the past few years and currently no known research exploring the efficacy of very early rehabilitation after thrombectomy, or any possible rehabilitation-related adverse effects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intra-arterial Thrombectomy
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jan 2023to 31 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cerebral stroke due to infarction of large vessels in the anterior circulation, including internal carotid artery (, middle cerebral artery (MCA) M1 or M2 segment, anterior cerebral artery (ACA) A1 segment
- Receive arterial thrombectomy (IA thrombectomy)
- Stable vital signs include heartbeat less than 130 bpm, systolic blood pressure less than 180mmHg, blood oxygen SpO2 >92%
- No use of pressors, oxygen masks or respirators after arterial thrombectomy
Who cannot join
- Posterior circulation large vessel stroke
- Functional score (mRS) ≥ 3 points before the stroke
- Other contraindications for rehabilitation treatment
- Neurosurgery immediately after this stroke
- Those who cannot receive rehabilitation within one week of stroke due to serious medical problems
- After the stroke, two specialists judged the end of life and arranged palliative and palliative treatment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Hsin-Chu Branch Hsinchu, Taiwan
Hsinchu
Hsing-Yu Chen, 035326151 ext. 523504
About this study
Official title: Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Taiwan
Early rehabilitation is feasible for stroke patients is still under debate. In addition, IA thrombectomy has been a new treatment for the past few years and currently no known research exploring the efficacy of very early rehabilitation after thrombectomy, or any possible rehabilitation-related adverse effects. Therefore, in this study, the investigators will investigate the effectiveness of earlier rehabilitation intervention after IA thrombectomy for cerebral large vessel occlusion based on functional independence.
Read the detailed description
The study will be the prospective randomized controlled trial, where patients eligible for inclusion will be randomly assigned to earlier rehabilitation group or control group. The investigators will analyze the correlation between frequency/intensity of rehabilitation and primary/secondary outcomes. Dose-response analysis for earlier rehabilitation will be performed.
- Conditions
- Intra-arterial Thrombectomy
- Being tested
- exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
exercise group: first bed exercise after 0~24hr onset ; sit at bed after 24~48hr onset control group: first bed exercise after 24~48hr onset ; sit at bed after 48~72hr onset
| Study group | Role | What they receive |
|---|---|---|
| effectiveness of earlier rehabilitation intervention after IA thrombectomy(experimental) | Experimental | The effectiveness of early rehabilitation interventions within 24 hours compared with the control group Receives: Other: exercise |
| effectiveness of earlier rehabilitation intervention after IA thrombectomy(control) | Active comparator | The effectiveness of early rehabilitation interventions compared with the experimental group Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS)
Modified Rankin Scale (mRS) at 3rd months after stroke:6 grades(higher grades means more disability)
Measured: 3rd months after stroke
Secondary outcomes (3)
Barthel Index
sum score:0~100(higher score means more functional independence )
Measured: 1st and 3rd months after stroke
Modified Rankin Scale (mRS)
Modified Rankin Scale (mRS) at 3rd months after stroke:6 grades(higher grades means
Measured: 1st months after stroke
Fugl-Meyer Assessment
U/E total score:66 L/E total score:34 the higher score means better movement performance
Measured: 1st and 3rd month after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start11 Jan 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-arterial ThrombectomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764278
- Sponsor's protocol ID
- 111-048-F
- Status last verified
- May 2023
- First submitted
- 21 Dec 2022
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Taiwan
- ClinicalTrials.gov ID
- NCT05764278
- Acronym / sponsor ID
- 111-048-F
- Conditions
- Intra-arterial Thrombectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Mar 2023 (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.
Early rehabilitation is feasible for stroke patients is still under debate. In addition, IA thrombectomy has been a new treatment for the past few years and currently no known research exploring the efficacy of very early rehabilitation after thrombectomy, or any possible rehabilitation-related adverse effects. Therefore, in this study, the investigators will investigate the effectiveness of earlier rehabilitation intervention after IA thrombectomy for cerebral large vessel occlusion based on functional independence.
Detailed description
The study will be the prospective randomized controlled trial, where patients eligible for inclusion will be randomly assigned to earlier rehabilitation group or control group. The investigators will analyze the correlation between frequency/intensity of rehabilitation and primary/secondary outcomes. Dose-response analysis for earlier rehabilitation will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| effectiveness of earlier rehabilitation intervention after IA thrombectomy(experimental) | Experimental | Other: exerciseThe effectiveness of early rehabilitation interventions within 24 hours compared with the control group |
| effectiveness of earlier rehabilitation intervention after IA thrombectomy(control) | Active comparator | Other: exerciseThe effectiveness of early rehabilitation interventions compared with the experimental group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Cerebral stroke due to infarction of large vessels in the anterior circulation, including internal carotid artery (, middle cerebral artery (MCA) M1 or M2 segment, anterior cerebral artery (ACA) A1 segment
- Receive arterial thrombectomy (IA thrombectomy)
- Stable vital signs include heartbeat less than 130 bpm, systolic blood pressure less than 180mmHg, blood oxygen SpO2 >92%
- No use of pressors, oxygen masks or respirators after arterial thrombectomy
Key exclusion criteria (6 listed)
- Posterior circulation large vessel stroke
- Functional score (mRS) ≥ 3 points before the stroke
- Other contraindications for rehabilitation treatment
- Neurosurgery immediately after this stroke
- Those who cannot receive rehabilitation within one week of stroke due to serious medical problems
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 |
|---|---|---|
| exerciseexercise group: first bed exercise after 0~24hr onset ; sit at bed after 24~48hr onset control group: first bed exercise after 24~48hr onset ; sit at bed after 48~72hr onset | Other | effectiveness of earlier rehabilitation intervention after IA thrombectomy(control), effectiveness of earlier rehabilitation intervention after IA thrombectomy(experimental) |
Primary outcome
Modified Rankin Scale (mRS)
Time frame: 3rd months after stroke
Modified Rankin Scale (mRS) at 3rd months after stroke:6 grades(higher grades means more disability)
3 secondary outcomes
Barthel Index
Time frame: 1st and 3rd months after stroke
Modified Rankin Scale (mRS)
Time frame: 1st months after stroke
Fugl-Meyer Assessment
Time frame: 1st and 3rd month after stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Intra-arterial Thrombectomy, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
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 6 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 19 May 2023. 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 Taiwan. 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 Hsing-Yu Chen (035326151 ext. 523504, G54088@hch.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) (time frame: 3rd months after stroke). 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 19 May 2023.