Stroke SequelaeNCT04116190
A Multidisciplinary Telerehabilitation for Stroke Patients
A study testing Telerehabilitation and Conventional inpatient rehabilitation in people with Stroke Sequelae, run by Vetrea Terveys Oy at 1 site in Finland.
Trial summary
Objective: Evaluate the feasibility of a multidisciplinary telerehabilitation for chronic stroke patients. Design: Chronic stroke patients eligible for multidisciplinary rehabilitation funded by the Social Insurance Institution were enrolled between September 2017 and March 2018 in a consecutive basis to receive a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- Telerehabilitation and Conventional inpatient rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2017to 31 May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic stroke (6 months or more) patient living in home
- eligible to receive rehabilitation funded by the Social Insurance Institution (meets the criteria of chronic disability and need for rehabilitation)
- for intervention group: capable to use a personal computer and telecommunication
Who cannot join
- no access or capability to use a personal computer
- significant problems in hearing, seeing or understanding information related to the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Multidisciplinary Telerehabilitation in Patients With Stroke - a Pilot Study
Objective: Evaluate the feasibility of a multidisciplinary telerehabilitation for chronic stroke patients.
Design: Chronic stroke patients eligible for multidisciplinary rehabilitation funded by the Social Insurance Institution were enrolled between September 2017 and March 2018 in a consecutive basis to receive a mixed program of inpatient rehabilitation and telerehabilitation in their homes or a traditional inpatient rehabilitation only.
Read more
Intervention: A rehabilitation course with a 3-day inpatient stay followed by an 8-week telerehabilitation period completed by 2-day evaluation stay in a rehab center. The control group received conventional multidisciplinary rehabilitation for two weeks in an inpatient setting.
Outcome and measures: Change in the Finnish version of Functional Status Questionnaire (FSQFin), the World Health Organization Quality of Life - Short version (WHOQOL-Bref), the Barthel Index, the Beck Depression Inventory (BDI21), and the Goal Attainment Scale (GAS) and a patient satisfaction questionnaire.
- Conditions
- Stroke Sequelae
- Being tested
- Telerehabilitation, Conventional inpatient rehabilitation
- Keywords
- rehabilitation, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationBehavioural
Short inpatient multidisciplinary rehabilitation followed by home-based telerehabilitation and a short evaluation period at the end of it.
Conventional inpatient rehabilitationBehavioural
Multidisciplinary inpatient rehabilitation, no adjustments due to the study.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation (TR) | Experimental | Shortened inpatient rehabilitation mixed with home-based telerehabilitation. Receives: Behavioral: Telerehabilitation |
| Conventional rehabilitation (CR) | Experimental | Traditional inpatient rehabilitation Receives: Behavioral: Conventional inpatient rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finnish version of the Functional Status Questionnaire (FSQfin)
Functional Status Questionnaire for evaluating self-management in home. Includes three dimensions: self-care, mobility and domestic life. Scale range for each dimension is 0-100 and higher scores indicate better outcome.
Measured: 8 weeks
Secondary outcomes (3)
World Health Organization Quality of Life - short version (WHOQOL-Bref)
Quality of life assessment. Includes four dimensions: physical health, psychological health, social relationships and environment. Scale range for each dimension is 0-100 and higher scores indicate better outcome.
Measured: 8 weeks
Beck Depression Inventory (BDI 21)
The Beck Depression Inventory for mood assessment. Scale range is 0-63 and higher scores indicate worse outcome.
Measured: 8 weeks
Barthel Index
for assessing need for help in basic activities of daily living. Scale range is 0-100 and higher scores indicate better outcome.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start1 Sep 2017
- Primary completion1 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Consecutive sampling
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vetrea Terveys Oy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kauko Pitkanen, PhD, Study director, VetreaNeuron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116190
- Sponsor's protocol ID
- Aimo2019
- Status last verified
- Oct 2019
- First submitted
- 28 Jun 2019
- Last updated
- 4 Oct 2019
- 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 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Multidisciplinary Telerehabilitation in Patients With Stroke - a Pilot Study
- ClinicalTrials.gov ID
- NCT04116190
- Acronym / sponsor ID
- Aimo2019
- Conditions
- Stroke Sequelae
- Keywords
- rehabilitation, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Vetrea Terveys OyUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 4 Oct 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.
Objective: Evaluate the feasibility of a multidisciplinary telerehabilitation for chronic stroke patients.
Design: Chronic stroke patients eligible for multidisciplinary rehabilitation funded by the Social Insurance Institution were enrolled between September 2017 and March 2018 in a consecutive basis to receive a mixed program of inpatient rehabilitation and telerehabilitation in their homes or a traditional inpatient rehabilitation only.
Intervention: A rehabilitation course with a 3-day inpatient stay followed by an 8-week telerehabilitation period completed by 2-day evaluation stay in a rehab center. The control group received conventional multidisciplinary rehabilitation for two weeks in an inpatient setting.
Outcome and measures: Change in the Finnish version of Functional Status Questionnaire (FSQFin), the World Health Organization Quality of Life - Short version (WHOQOL-Bref), the Barthel Index, the Beck Depression Inventory (BDI21), and the Goal Attainment Scale (GAS) and a patient satisfaction questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Consecutive sampling
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation (TR) | Experimental | Behavioral: TelerehabilitationShortened inpatient rehabilitation mixed with home-based telerehabilitation. |
| Conventional rehabilitation (CR) | Experimental | Behavioral: Conventional inpatient rehabilitationTraditional inpatient rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic stroke (6 months or more) patient living in home
- eligible to receive rehabilitation funded by the Social Insurance Institution (meets the criteria of chronic disability and need for rehabilitation)
- for intervention group: capable to use a personal computer and telecommunication
Key exclusion criteria (2 listed)
- no access or capability to use a personal computer
- significant problems in hearing, seeing or understanding information related to the intervention
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 |
|---|---|---|
| TelerehabilitationShort inpatient multidisciplinary rehabilitation followed by home-based telerehabilitation and a short evaluation period at the end of it. | Behavioural | Telerehabilitation (TR) |
| Conventional inpatient rehabilitationMultidisciplinary inpatient rehabilitation, no adjustments due to the study. | Behavioural | Conventional rehabilitation (CR) |
Primary outcome
Finnish version of the Functional Status Questionnaire (FSQfin)
Time frame: 8 weeks
Functional Status Questionnaire for evaluating self-management in home. Includes three dimensions: self-care, mobility and domestic life. Scale range for each dimension is 0-100 and higher scores indicate better outcome.
3 secondary outcomes
World Health Organization Quality of Life - short version (WHOQOL-Bref)
Time frame: 8 weeks
Beck Depression Inventory (BDI 21)
Time frame: 8 weeks
Barthel Index
Time frame: 8 weeks
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 4 Oct 2019.
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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.
Kauko Pitkanen, PhD study director
VetreaNeuron
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 and Conventional inpatient rehabilitation in people with Stroke Sequelae, run by Vetrea Terveys Oy at 1 site in Finland.
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 2 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 4 Oct 2019. 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 Finland. 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?
Finnish version of the Functional Status Questionnaire (FSQfin) (time frame: 8 weeks). 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 4 Oct 2019.