HemiplegiaNCT05897762
The Effects of Telerehabilitation in Chronic Hemiplegic Patients
A study testing Tele rehabilitation Group in people with Hemiplegia, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The present study was conducted to investigate the effects of telerehabilitation on upper extremity functions and activities of daily living in chronic hemiplegic patients. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- Tele rehabilitation Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jan 2022
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having been diagnosed with stroke between the ages of 40-70
- It has been 12 months since the stroke
- Individuals with upper extremity spasticity level (Modified Ashworth Scale (MAS) score ≤ 3)
- Hand and upper extremity values above 3 according to Brunnstrom motor staging
- Individuals with ischemic, middle cerebral artery involvement will be taken.
Who cannot join
- Having advanced apraxia and aphasia
- Patients who do not have the cooperation to perform verbal commands and exercise training
- Patients who have undergone any botulinum toxin application in the last 6 months
- Patients with significant visual and hearing loss
- Individuals who do not have the necessary technological competence to provide remote video communication at home will not be accepted.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Telerehabilitation on Upper Extremity Functions and Activities of Daily Living in Chronic Hemiplegic Patients
The present study was conducted to investigate the effects of telerehabilitation on upper extremity functions and activities of daily living in chronic hemiplegic patients.
Read the detailed description
A total of 40 chronic hemiplegic subjects were included in the study. The patients were divided into 2 groups by simple randomization method. As the Telerehabilitation Group (TR), Group 1 completed the treatment program, which included upper extremity and lower extremity strengthening exercises, for eight weeks, three days a week for 45-60 minutes, 10 repetitions, with online supervision. Group 2 was planned as a face-to-face training group and the same exercises were performed in the clinical setting, accompanied by a physiotherapist. The evaluations were made before and after the treatment. The Modified Ashworth Scale was used for upper extremity spasticity evaluation. The Wolf Motor Function Test was used to evaluate upper extremity functionality. The Barthel ADL Index was used to evaluate Activities of Daily Living (ADL). The Brunnstrom Staging Survey was used to evaluate the level of motor recovery. The Treatment Satisfaction Inquiry Survey was used to evaluate the satisfaction of the patients with the treatment method. Heart Rate (HR) values and oxygen saturation (SaO2) were measured with Pulse Oximetry to monitor vital signs.
- Conditions
- Hemiplegia
- Being tested
- Tele rehabilitation Group
- Keywords
- fuctionallity, chronic hemiplegia, Spastisity, Tele-rehabilitation, upper extremity
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele rehabilitation GroupBehavioural
It has been determined that the telerehabilitation method applied in chronic hemiplegic patients increases daily living activities, upper extremity functionality, and spasticity levels decrease.
| Study group | Role | What they receive |
|---|---|---|
| Clinic Grup | Other | the same exercises were performed in the clinical setting, accompanied by a physiotherapist. The evaluations were made before and after the treatment. Receives: Behavioral: Tele rehabilitation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
spasticity levels
Spasticty will ve evaluated with Modifiye Ashworth Scale
Measured: Pre-Treatment and post treatment evaluations will ve recorded. (8 Weeks periods)
Upper Extremity functionality
Upper extremity functionality evaluated with DASH
Measured: Pre-Treatment and post treatment evaluations will ve recorded. (8 Weeks periods)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Jan 2021
- Primary completion1 Jun 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Karakurt, Hasan Kalyoncu University
- Investigators
- Deniz Kocamaz, Assist Prof, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897762
- Sponsor's protocol ID
- HasanKU"
- Status last verified
- Mar 2023
- First submitted
- 4 Feb 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Telerehabilitation on Upper Extremity Functions and Activities of Daily Living in Chronic Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT05897762
- Acronym / sponsor ID
- HasanKU"
- Conditions
- Hemiplegia
- Keywords
- fuctionallity, chronic hemiplegia, Spastisity, Tele-rehabilitation, upper extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 9 Jun 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.
The present study was conducted to investigate the effects of telerehabilitation on upper extremity functions and activities of daily living in chronic hemiplegic patients.
Detailed description
A total of 40 chronic hemiplegic subjects were included in the study. The patients were divided into 2 groups by simple randomization method. As the Telerehabilitation Group (TR), Group 1 completed the treatment program, which included upper extremity and lower extremity strengthening exercises, for eight weeks, three days a week for 45-60 minutes, 10 repetitions, with online supervision. Group 2 was planned as a face-to-face training group and the same exercises were performed in the clinical setting, accompanied by a physiotherapist. The evaluations were made before and after the treatment. The Modified Ashworth Scale was used for upper extremity spasticity evaluation. The Wolf Motor Function Test was used to evaluate upper extremity functionality. The Barthel ADL Index was used to evaluate Activities of Daily Living (ADL). The Brunnstrom Staging Survey was used to evaluate the level of motor recovery. The Treatment Satisfaction Inquiry Survey was used to evaluate the satisfaction of the patients with the treatment method. Heart Rate (HR) values and oxygen saturation (SaO2) were measured with Pulse Oximetry to monitor vital signs.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinic Grup | Other | Behavioral: Tele rehabilitation Groupthe same exercises were performed in the clinical setting, accompanied by a physiotherapist. The evaluations were made before and after the treatment. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Having been diagnosed with stroke between the ages of 40-70
- It has been 12 months since the stroke
- Individuals with upper extremity spasticity level (Modified Ashworth Scale (MAS) score ≤ 3)
- Hand and upper extremity values above 3 according to Brunnstrom motor staging
- Individuals with ischemic, middle cerebral artery involvement will be taken.
Key exclusion criteria (5 listed)
- Having advanced apraxia and aphasia
- Patients who do not have the cooperation to perform verbal commands and exercise training
- Patients who have undergone any botulinum toxin application in the last 6 months
- Patients with significant visual and hearing loss
- Individuals who do not have the necessary technological competence to provide remote video communication at home will not be accepted.
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 |
|---|---|---|
| Tele rehabilitation GroupIt has been determined that the telerehabilitation method applied in chronic hemiplegic patients increases daily living activities, upper extremity functionality, and spasticity levels decrease. | Behavioural | Clinic Grup |
Primary outcome
spasticity levels
Time frame: Pre-Treatment and post treatment evaluations will ve recorded. (8 Weeks periods)
Spasticty will ve evaluated with Modifiye Ashworth Scale
Upper Extremity functionality
Time frame: Pre-Treatment and post treatment evaluations will ve recorded. (8 Weeks periods)
Upper extremity functionality evaluated with DASH
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 9 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Hemiplegia
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Active, not recruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
RecruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
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.
Deniz Kocamaz, Assist Prof study director
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele rehabilitation Group in people with Hemiplegia, run by Hasan Kalyoncu University at 1 site 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 5 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 9 Jun 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 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?
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?
spasticity levels (time frame: Pre-Treatment and post treatment evaluations will ve recorded. (8 Weeks periods)). 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 9 Jun 2023.