StrokestrokeNCT03965910
Importance of Early Rehabilitation in Stroke Patients
A study testing Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data in people with Stroke, run by Bezmialem Vakif University.
Trial summary
Stroke is one of the leading health problems in the community and it is the most common life-threatening neurological disease impairing the quality of life. Early rehabilitation of stroke is very important. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 2017
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients suffering cerebrovascular accident (CVA)-associated stroke for the first time with a cortical or subcortical unilateral ischemia or hemorrhage
- The patients aged 35-75 years
- Patiients with ability to understand and follow the instructions
- Patients with the absence of serious cognitive deficits.
Who cannot join
- Patients who had spinal-cord lesion
- Patients who had history of traumatic brain injury,
- Patients who had accompanying neurological disease (multiple sclerosis, Parkinson's disease, dementia)
- Patients who had tumor
- Patients who had history of convulsions
About this study
Official title: Demonstration the Importance of the Early Rehabilitation in Stroke Patients Based on Diffüsion Tensor Imaging Data
Stroke is one of the leading health problems in the community and it is the most common life-threatening neurological disease impairing the quality of life. Early rehabilitation of stroke is very important. The purpose of our study was to evaluate, through clinical examination, whether there was any difference between patients who underwent early rehabilitation and those who underwent late rehabilitation in terms of improvements in motor and functional impairment after rehabilitation, and also to evaluate this difference objectively by analyzing white-matter pathways (corticospinal tracts) using DTI.
Read the detailed description
Methods: Twenty-eight (28) adults (12 women, 16 men, average age 58 years) with first-time stroke who met the study criteria were divided into two groups depending on the duration of their stroke at the time of their presentation to our facility. Group 1 consisted of patients who underwent rehabilitation program within the first 1-4 weeks after stroke, whereas Group 2 consisted of patients who underwent rehabilitation program within 5-8 weeks after stroke. Both groups were evaluated using the BRS, FMA scale, FAC and BI scales. For cranial imaging, DTI was obtained 1 day before and 1 day after treatment. FA and ADC values of corticospinal tracts were performed using DTI.
Intervention: Patients were enrolled in a rehabilitation program, which was designed for a total of 4 weeks, with daily sessions lasting a total of 1 h on 5 days of a week.
- Conditions
- Stroke
- Being tested
- Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data
- Keywords
- stroke, rehabilitation, diffusion tensor imaging
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging DataOther
Also called Poststroke rehabilitation and diffusion tensor imaging
Twenty-eight stroke patients aged 36-72 years admitted to the our Physical Medicine and Rehabilitation Outpatient Clinics were included in this prospective study. After the approval of the ethics committee, written informed consent was obtained from the patients after they were informed about the content and purpose of the study, the schedule of rehabilitation to be administered, and the features of cranial magnetic resonance imaging (MRI) to be performed. Patients with confirmed diagnosis of stroke by computed tomography and/or MRI techniques were randomized into two groups according to the onset of post-stroke rehabilitation. The patients were randomized according to the duration of their admission to our clinic for rehabilitation. Group 1 consisted of patients admitted to our clinic within 1-4 weeks after stroke; Group 2 consisted of patients admitted within 5-8 weeks after stroke.
Late initiation of rehabilitation in Group 2 patients is not a condition related to our clinic.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Other | Group 1:Early rehabilitation Receives: Other: Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data |
| group 2 | Other | Group 2:Late rehabilitation Receives: Other: Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cranial diffusion tractography
Diffusion tensor imaging (DTI) is based on determining tissue structure by measuring diffusion rate and direction of movement of water molecules in vivo. DTI is the only in vivo method of mapping white-matter pathways in the human brain. Tractography is the technique for mapping white-matter structure with DTI data
Measured: performed 1 day before and 1 month after treatment
Change in Fugl-Meyer Assessment Scale score(FMA)
FMA is a stroke-specific, performance-based impairment index. (0 point : Flaccid paralysis 100points=Normal).
Measured: performed 1 day before the end of the second week of the treatment and 1 day after the completion of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study startNov 2016
- Primary completionDec 2016
- Study completionNov 2017
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.
- More trials run by Bezmialem Vakif 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaşar Keskin, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965910
- Sponsor's protocol ID
- 28/09/2016-12 /25
- Acronym
- stroke
- Status last verified
- May 2019
- First submitted
- 10 Apr 2019
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not to want to share IPD of my study. But if a researcher reaches me about the subject and wants me to share bended, I share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration the Importance of the Early Rehabilitation in Stroke Patients Based on Diffüsion Tensor Imaging Data
- ClinicalTrials.gov ID
- NCT03965910
- Acronym / sponsor ID
- stroke / 28/09/2016-12 /25
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, diffusion tensor imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 29 May 2019 (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.
Stroke is one of the leading health problems in the community and it is the most common life-threatening neurological disease impairing the quality of life. Early rehabilitation of stroke is very important. The purpose of our study was to evaluate, through clinical examination, whether there was any difference between patients who underwent early rehabilitation and those who underwent late rehabilitation in terms of improvements in motor and functional impairment after rehabilitation, and also to evaluate this difference objectively by analyzing white-matter pathways (corticospinal tracts) using DTI.
Detailed description
Methods: Twenty-eight (28) adults (12 women, 16 men, average age 58 years) with first-time stroke who met the study criteria were divided into two groups depending on the duration of their stroke at the time of their presentation to our facility. Group 1 consisted of patients who underwent rehabilitation program within the first 1-4 weeks after stroke, whereas Group 2 consisted of patients who underwent rehabilitation program within 5-8 weeks after stroke. Both groups were evaluated using the BRS, FMA scale, FAC and BI scales. For cranial imaging, DTI was obtained 1 day before and 1 day after treatment. FA and ADC values of corticospinal tracts were performed using DTI.
Intervention: Patients were enrolled in a rehabilitation program, which was designed for a total of 4 weeks, with daily sessions lasting a total of 1 h on 5 days of a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Other | Other: Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging DataGroup 1:Early rehabilitation |
| group 2 | Other | Other: Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging DataGroup 2:Late rehabilitation |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients suffering cerebrovascular accident (CVA)-associated stroke for the first time with a cortical or subcortical unilateral ischemia or hemorrhage
- The patients aged 35-75 years
- Patiients with ability to understand and follow the instructions
- Patients with the absence of serious cognitive deficits.
Key exclusion criteria (5 listed)
- Patients who had spinal-cord lesion
- Patients who had history of traumatic brain injury,
- Patients who had accompanying neurological disease (multiple sclerosis, Parkinson's disease, dementia)
- Patients who had tumor
- Patients who had history of convulsions
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 |
|---|---|---|
| Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging DataAlso: Poststroke rehabilitation and diffusion tensor imagingTwenty-eight stroke patients aged 36-72 years admitted to the our Physical Medicine and Rehabilitation Outpatient Clinics were included in this prospective study. After the approval of the ethics committee, written informed consent was obtained from the patients after they were informed about the content and purpose of the study, the schedule of rehabilitation to be administered, and the features of cranial magnetic resonance imaging (MRI) to be performed. Patients with confirmed diagnosis of stroke by computed tomography and/or MRI techniques were randomized into two groups according to the onset of post-stroke rehabilitation. The patients were randomized according to the duration of their admission to our clinic for rehabilitation. Group 1 consisted of patients admitted to our clinic within 1-4 weeks after stroke; Group 2 consisted of patients admitted within 5-8 weeks after stroke. Late initiation of rehabilitation in Group 2 patients is not a condition related to our clinic. | Other | group 1, group 2 |
Primary outcome
Change in Cranial diffusion tractography
Time frame: performed 1 day before and 1 month after treatment
Diffusion tensor imaging (DTI) is based on determining tissue structure by measuring diffusion rate and direction of movement of water molecules in vivo. DTI is the only in vivo method of mapping white-matter pathways in the human brain. Tractography is the technique for mapping white-matter structure with DTI data
Change in Fugl-Meyer Assessment Scale score(FMA)
Time frame: performed 1 day before the end of the second week of the treatment and 1 day after the completion of the treatment
FMA is a stroke-specific, performance-based impairment index. (0 point : Flaccid paralysis 100points=Normal).
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 29 May 2019.
- Individual participant dataSharing planned: No. I do not to want to share IPD of my study. But if a researcher reaches me about the subject and wants me to share bended, I share IPD.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data in people with Stroke, run by Bezmialem Vakif University.
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 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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 in Cranial diffusion tractography (time frame: performed 1 day before and 1 month after treatment). 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 29 May 2019.