Hemorrhagic StrokeTeleHomeNCT06365463
Telerehabilitation to Improve Balance and Mobility in Patients After Stroke
A study testing Telerehabilitation in people with Hemorrhagic Stroke and Ischemic Stroke, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
Trial summary
Telerehabilitation is an effective rehabilitation method that allows patients to receive physiotherapy remotely in their homes. The purpose of this study was to investigate the effects of home-based remote group training for balance and mobility on activities and body functions. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemorrhagic Stroke, Ischemic Stroke
- What is being tested?
- Telerehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSlovenia
- Study dates
- 9 Apr 2024to 30 Jun 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic phase of ischemic or haemorrhagic stroke (>6 months after stroke)
- ability to walk independently on level ground or on all surfaces with or without a walking aid
- mild balance deficit
- sufficient cognitive and communicative abilities for participation
- access to a personal computer with a camera, connected to the Internet
Who cannot join
- stroke in the brainstem or cerebellum
- additional neurological condition
- musculoskeletal impairments that would interfere with the training
- advanced heart failure
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
About this study
Official title: Telerehabilitation to Improve Balance and Mobility in Patients After Stroke: Group Physiotherapy Performed in Individuals' Homes
Telerehabilitation is an effective rehabilitation method that allows patients to receive physiotherapy remotely in their homes. The purpose of this study was to investigate the effects of home-based remote group training for balance and mobility on activities and body functions.
Read the detailed description
Patients in the chronic post-stroke phase will be assessed for balance and mobility before and after remotely conducted group training. The training will last for 6 weeks, with two 60-minute sessions of balance and mobility training per week. Two consecutive groups will participate. The participants's balance and weight-bearing symmetry will be comprehensive assessed, as well their sit-to-stand ability, walking speed, and satisfaction with the remote training. Detailed inclusion and exclusion criteria are specified in the appropriate section.
- Conditions
- Hemorrhagic Stroke, Ischemic Stroke
- Being tested
- Telerehabilitation
- Keywords
- Stroke, Telerehabilitation, Balance, Mobility
- Medical subject headings
- Hemorrhagic Stroke, Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationBehavioural
The training will last for 6 weeks, with two 60-minute sessions of balance and mobility training per week. Two consecutive groups will participate.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group | Experimental | Remote group training to improve balance and mobility Receives: Behavioral: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in balance
Assessed using Mini-Balance Evaluation Systems Test (scale score range 0-28; higher scores mean a better outcome)
Measured: Assessment 1-5 days before and 1-5 days after the training
Change in limits of stability
Assessed using a force plate
Measured: Assessment 1-5 days before and 1-5 days after the training
Change in weight-bearing symmetry
Assessed using a force plate
Measured: Assessment 1-5 days before and 1-5 days after the training
Secondary outcomes (2)
Change in mobility
Assessed using 5 Times Sit-to-Stand test (measured in seconds; longer times a worse outcome)
Measured: Assessment 1-5 days before and 1-5 days after the training
Change in walking speed
Assessed using 10-Meter Walk Test (expressed in metres/second; higher speed means a better outcome)
Measured: Assessment 1-5 days before and 1-5 days after the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start9 Apr 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urška Puh, PT, PhD, Principal investigator, University Rehabilitation Institute, Rehabilitation of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365463
- Sponsor's protocol ID
- URIS202401
- Acronym
- TeleHome
- Status last verified
- Oct 2024
- First submitted
- 9 Apr 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation to Improve Balance and Mobility in Patients After Stroke: Group Physiotherapy Performed in Individuals' Homes
- ClinicalTrials.gov ID
- NCT06365463
- Acronym / sponsor ID
- TeleHome / URIS202401
- Conditions
- Hemorrhagic Stroke, Ischemic Stroke
- Keywords
- Stroke, Telerehabilitation, Balance, Mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 15 Apr 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 is an effective rehabilitation method that allows patients to receive physiotherapy remotely in their homes. The purpose of this study was to investigate the effects of home-based remote group training for balance and mobility on activities and body functions.
Detailed description
Patients in the chronic post-stroke phase will be assessed for balance and mobility before and after remotely conducted group training. The training will last for 6 weeks, with two 60-minute sessions of balance and mobility training per week. Two consecutive groups will participate. The participants's balance and weight-bearing symmetry will be comprehensive assessed, as well their sit-to-stand ability, walking speed, and satisfaction with the remote training. Detailed inclusion and exclusion criteria are specified in the appropriate section.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Experimental | Behavioral: TelerehabilitationRemote group training to improve balance and mobility |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- chronic phase of ischemic or haemorrhagic stroke (>6 months after stroke)
- ability to walk independently on level ground or on all surfaces with or without a walking aid
- mild balance deficit
- sufficient cognitive and communicative abilities for participation
- access to a personal computer with a camera, connected to the Internet
Key exclusion criteria (4 listed)
- stroke in the brainstem or cerebellum
- additional neurological condition
- musculoskeletal impairments that would interfere with the training
- advanced heart failure
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 |
|---|---|---|
| TelerehabilitationThe training will last for 6 weeks, with two 60-minute sessions of balance and mobility training per week. Two consecutive groups will participate. | Behavioural | Telerehabilitation group |
Primary outcome
Change in balance
Time frame: Assessment 1-5 days before and 1-5 days after the training
Assessed using Mini-Balance Evaluation Systems Test (scale score range 0-28; higher scores mean a better outcome)
Change in limits of stability
Time frame: Assessment 1-5 days before and 1-5 days after the training
Assessed using a force plate
Change in weight-bearing symmetry
Time frame: Assessment 1-5 days before and 1-5 days after the training
Assessed using a force plate
2 secondary outcomes
Change in mobility
Time frame: Assessment 1-5 days before and 1-5 days after the training
Change in walking speed
Time frame: Assessment 1-5 days before and 1-5 days after the training
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 Oct 2024.
Related trials for Hemorrhagic Stroke
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
Recruiting
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
Stroke, Ischemic, Chronic Stroke
RecruitingPhase 3
Thrombolysis in Factor Xa-inhibitors Trial
Stroke, Stroke (in Patients With Atrial Fibrillation)
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
Urška Puh, PT, PhD principal investigator
University Rehabilitation Institute, Rehabilitation of Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Hemorrhagic Stroke and Ischemic Stroke, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
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 4 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 Oct 2024. 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 Slovenia. 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?
Change in balance (time frame: Assessment 1-5 days before and 1-5 days after the training). The study lists 3 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 Oct 2024.