Stroke, AcuteNCT06261099
Telerehabilitation-Based Early Upper Extremity Training in Stroke Patients
A study of Stroke, Acute, run by Suleyman Demirel University at 2 sites in Turkey (Türkiye).
Trial summary
Telerehabilitation method, which is an alternative to face-to-face rehabilitation practices for stroke patients who need intensive, regular and long-term rehabilitation in the early period, has been popularly used in recent years. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Stroke, Acute
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 8 Feb 2024to 27 Nov 2025
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 30-65, with a history of stroke within the last month,
- Mini Mental Score ≥ 24, 1-10 after discharge. on the day,
- patients who can sit for at least 30 seconds, exhibit a hemiparetic condition, and are clinically stable
Who cannot join
- Flaccid hemiplegia detected by anamnesis and physical examination,
- Has spasticity in the upper extremity with a severity greater than 1+ according to the Modified Ashworth Scale,
- patients with severe dementia and dysfunction of the upper extremity joints due to a previous musculoskeletal disease
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Suleyman Demirel University
Isparta, Merkez
MEHMET DURAY, +90 506 473 11 65, mehmetduray@sdu.edu.tr
- Recruiting
Güler Ertuğrul
Kocaeli, İ̇zmi̇t
GÜLER ERTUĞRUL, +90 531 950 05 90, gertugrul004@gmail.com
About this study
Official title: The Effect of Telerehabilitation-Based Early Upper Extremity Training on Upper Extremity Function and Proprioception in Stroke Patients
Telerehabilitation method, which is an alternative to face-to-face rehabilitation practices for stroke patients who need intensive, regular and long-term rehabilitation in the early period, has been popularly used in recent years. Telerehabilitation is a practice in which the patient participates in the treatment via digital media without the need for the patient to come to the clinic.
Read the detailed description
After the sociodemographic data of the participants are recorded, Mini Mental Test (MMT) will be applied to evaluate the cognitive status. Upper extremity functions of patients eligible for the study will be evaluated with the Fugl-Meyer Upper Extremity Scale (FM-UE), proprioception evaluation will be evaluated with the Laser-pointer Assisted Angle Reproduction Test, activities of daily living will be evaluated with the Modified Barthel Index, and reaching performance will be evaluated with the Reaching Performance Scale. Characteristics of the patients participating in the study and all outcome measurements before and after treatment will be evaluated by a blinded physiotherapist. A researcher blinded to the exercise groups and evaluation results will perform the statistical analysis.
- Conditions
- Stroke, Acute
- Being tested
- control + working group
- Keywords
- telerehabilitation, Upper Extremity, rehabilitation, Proprioception
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control + working groupOther
Upper extremity positioning, overhead activity training, reaching activities, weight transfer exercises, proprioceptive exercises, and daily living activities training will be applied to this group using the telerehabilitation method, which was applied to in 5 sessions per week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Exercises including upper extremity positioning, overhead activity training, reaching activities, weight transfer exercises, proprioceptive exercises, and daily living activities training will be applied to this group, 5 sessions per week for 6 weeks. Since the functional recovery of the upper extremity after stroke will be slow, the exercise program is planned to be 5 days a week due to the necessity of applying an intense exercise program in the early period. All patients will be asked to perform exercises under the supervision of a physiotherapist as a home program on other days of the week. |
| kontrol+ working group | Experimental | Upper extremity positioning, overhead activity training, reaching activities, weight transfer exercises, proprioceptive exercises, and daily living activities training will be applied to this group using the telerehabilitation method, which was applied to the control group in 5 sessions per week for 6 weeks. The telerehabilitation program will be carried out using an application that provides remote video access called Zoom. Since the functional recovery of the upper extremity after stroke will be slow, the exercise program is planned to be 5 days a week due to the necessity of applying an intense exercise program in the early period. All patients will be asked to perform exercises under the supervision of a physiotherapist as a home program on other days of the week. Receives: Other: control + working group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental Test
It is used to evaluate the cognitive status of patients. It is a simple, short and valid test that is widely used in people with stroke. With this test, various cognitive functions of people such as orientation, recording memory, attention and calculation, recall and language are evaluated. The maximum score that can be obtained is 30. Getting a score of 24 or above indicates that the patient's cognitive functions are within normal limits.
Measured: six weeks
Fugl Meyer Motor Function Scale
Motor performance is evaluated in stroke patients. Each item is given a score from 0 to 2, depending on performance: 2 points; complete detailing, 1 point; partial work of details, 0 points; It is given if details cannot be achieved. The maximum motor performance score for the upper extremity is 66 points.
Measured: six weeks
Laser-pointer Assisted Angle Reproduction Test
It evaluates proprioceptive deviation in stroke patients. Shoulder flexion is measured three times at 45◦, 60◦ and 90◦, and upper extremity proprioception is evaluated by taking the average result of the three measurements.
Measured: six weeks
Modified Barthel Index
Determines the functional adequacy, dependency level and rehabilitation services of stroke patients. Items on the scale are rated between 0 and 15 points in 5-point increments depending on the question. 0-20 points are considered fully dependent, 21-61 points are considered highly dependent, 62-90 points are considered moderately dependent, 91-99 points are considered mildly dependent, and 100 points are considered fully independent.
Measured: six weeks
Reaching Performance Scale
It evaluates compensatory movements for upper extremity extension in stroke patients. Scores on items 1 to 5 are used to identify deficiencies in specific aspects of movement, with scores ranging from 0 to 18 being obtained depending on changing performance.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start8 Feb 2024
- Primary completion27 Feb 2025 (estimated)
- Study completion27 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Crossover
- Model description
- prospective double-blind, randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güler ERTUĞRUL, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261099
- Sponsor's protocol ID
- 037
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 15 Feb 2024
- 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 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telerehabilitation-Based Early Upper Extremity Training on Upper Extremity Function and Proprioception in Stroke Patients
- ClinicalTrials.gov ID
- NCT06261099
- Acronym / sponsor ID
- 037
- Conditions
- Stroke, Acute
- Keywords
- telerehabilitation, Upper Extremity, rehabilitation, Proprioception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 27 Feb 2025 (estimated)
- Study completion
- 27 Nov 2025 (estimated)
- First posted
- 15 Feb 2024 (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.
Telerehabilitation method, which is an alternative to face-to-face rehabilitation practices for stroke patients who need intensive, regular and long-term rehabilitation in the early period, has been popularly used in recent years. Telerehabilitation is a practice in which the patient participates in the treatment via digital media without the need for the patient to come to the clinic.
Detailed description
After the sociodemographic data of the participants are recorded, Mini Mental Test (MMT) will be applied to evaluate the cognitive status. Upper extremity functions of patients eligible for the study will be evaluated with the Fugl-Meyer Upper Extremity Scale (FM-UE), proprioception evaluation will be evaluated with the Laser-pointer Assisted Angle Reproduction Test, activities of daily living will be evaluated with the Modified Barthel Index, and reaching performance will be evaluated with the Reaching Performance Scale. Characteristics of the patients participating in the study and all outcome measurements before and after treatment will be evaluated by a blinded physiotherapist. A researcher blinded to the exercise groups and evaluation results will perform the statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective double-blind, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Exercises including upper extremity positioning, overhead activity training, reaching activities, weight transfer exercises, proprioceptive exercises, and daily living activities training will be applied to this group, 5 sessions per week for 6 weeks. Since the functional recovery of the upper extremity after stroke will be slow, the exercise program is planned to be 5 days a week due to the necessity of applying an intense exercise program in the early period. All patients will be asked to perform exercises under the supervision of a physiotherapist as a home program on other days of the week. |
| kontrol+ working group | Experimental | Other: control + working groupUpper extremity positioning, overhead activity training, reaching activities, weight transfer exercises, proprioceptive exercises, and daily living activities training will be applied to this group using the telerehabilitation method, which was applied to the control group in 5 sessions per week for 6 weeks. The telerehabilitation program will be carried out using an application that provides remote video access called Zoom. Since the functional recovery of the upper extremity after stroke will be slow, the exercise program is planned to be 5 days a week due to the necessity of applying an intense exercise program in the early period. All patients will be asked to perform exercises under the supervision of a physiotherapist as a home program on other days of the week. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 30-65, with a history of stroke within the last month,
- Mini Mental Score ≥ 24, 1-10 after discharge. on the day,
- patients who can sit for at least 30 seconds, exhibit a hemiparetic condition, and are clinically stable
Key exclusion criteria (3 listed)
- Flaccid hemiplegia detected by anamnesis and physical examination,
- Has spasticity in the upper extremity with a severity greater than 1+ according to the Modified Ashworth Scale,
- patients with severe dementia and dysfunction of the upper extremity joints due to a previous musculoskeletal disease
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 |
|---|---|---|
| control + working groupUpper extremity positioning, overhead activity training, reaching activities, weight transfer exercises, proprioceptive exercises, and daily living activities training will be applied to this group using the telerehabilitation method, which was applied to in 5 sessions per week for 6 weeks. | Other | kontrol+ working group |
Primary outcome
Mini Mental Test
Time frame: six weeks
It is used to evaluate the cognitive status of patients. It is a simple, short and valid test that is widely used in people with stroke. With this test, various cognitive functions of people such as orientation, recording memory, attention and calculation, recall and language are evaluated. The maximum score that can be obtained is 30. Getting a score of 24 or above indicates that the patient's cognitive functions are within normal limits.
Fugl Meyer Motor Function Scale
Time frame: six weeks
Motor performance is evaluated in stroke patients. Each item is given a score from 0 to 2, depending on performance: 2 points; complete detailing, 1 point; partial work of details, 0 points; It is given if details cannot be achieved. The maximum motor performance score for the upper extremity is 66 points.
Laser-pointer Assisted Angle Reproduction Test
Time frame: six weeks
It evaluates proprioceptive deviation in stroke patients. Shoulder flexion is measured three times at 45◦, 60◦ and 90◦, and upper extremity proprioception is evaluated by taking the average result of the three measurements.
Modified Barthel Index
Time frame: six weeks
Determines the functional adequacy, dependency level and rehabilitation services of stroke patients. Items on the scale are rated between 0 and 15 points in 5-point increments depending on the question. 0-20 points are considered fully dependent, 21-61 points are considered highly dependent, 62-90 points are considered moderately dependent, 91-99 points are considered mildly dependent, and 100 points are considered fully independent.
Reaching Performance Scale
Time frame: six weeks
It evaluates compensatory movements for upper extremity extension in stroke patients. Scores on items 1 to 5 are used to identify deficiencies in specific aspects of movement, with scores ranging from 0 to 18 being obtained depending on changing performance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stroke, Acute, run by Suleyman Demirel University at 2 sites in Turkey (Türkiye).
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 3 inclusion and 3 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 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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 Güler ERTUĞRUL (+90 531 950 05 90, gertugrul004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental Test (time frame: six weeks). The study lists 5 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 15 Feb 2024.