StrokeNCT04647812
Technology-assisted Rehabilitation After Acute Stroke
A study testing Technology-assisted rehabilitation and Conventional rehabilitation in people with Stroke, run by Vetrea Terveys Oy at 1 site in Finland.
Trial summary
The aim of the study is to evaluate the effects and costs of an intensified rehabilitation for stroke patients. Using novel technologies the patients will receive an augmented exercise therapy during the first weeks after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Technology-assisted rehabilitation and Conventional rehabilitation
- 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 siteFinland
- Study dates
- 4 Jan 2021to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or more
- first stroke
Who cannot join
- unstable cardiopulmonary condition
- severe cognitive disorder
- aphasia
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Vetrea
Kuopio, Northern Savonia, 71130
Kauko Pitkänen, PhD, +358505965289, kauko.pitkanen@vetrea.fi
About this study
The aim of the study is to evaluate the effects and costs of an intensified rehabilitation for stroke patients. Using novel technologies the patients will receive an augmented exercise therapy during the first weeks after stroke. The effects on restoration of functions as well as on the costs incurred from social and health care services will be assessed and compared to the conventional rehabilitation over 6 month follow-up.
Read the detailed description
The intervention consists of technology-assisted multidisciplinary rehabilitation for 3 weeks followed by an 8-week period of supervised home-based telerehabilitation and a weekly group exercise in an outpatient clinic. The effects on mobility, upper extremity motor functions and activities of daily living will be assessed using FAC, hand grip force, shoulder elevation test, WHODAS 2.0 and PROMIS scales. The costs incurred from social and health care services over 6 months will be compared to the control group receiving conventional rehabilitation. Patients aged 18 or more with their first stroke and stable cardiopulmonary condition will be consecutively recruited first into the control group (n=20) and thereafter into the experimental group (n=20). Patients with a severe cognitive deficit or aphasia will be excluded.
- Conditions
- Stroke
- Being tested
- Technology-assisted rehabilitation, Conventional rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-assisted rehabilitationBehavioural
Augmented exercise therapy with novel technology and home-based telerehabilitation
Conventional rehabilitationBehavioural
Traditional multidisciplinary in-patient rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Technology-assisted rehabilitation | Experimental | Augmented exercise therapy with novel technology Receives: Behavioral: Technology-assisted rehabilitation |
| Conventional rehabilitation | Experimental | Traditional multidisciplinary rehabilitation Receives: Behavioral: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHODAS 2.0
World Health Organization Disability Assessment Schedule - 12 questions scoring 1 to 5 yielding a total score from 12 to 60. A higher score means an increasing disability.
Measured: 6 months
service use and costs
amount and costs of social and health care services used
Measured: 6 months
Secondary outcomes (4)
PROMIS Global 10
Patient Reported Outcome Measurement Information System - a generic global health scale v1.2 consists of 10 questions across 6 health items. Two of the items (Physical and Mental) can be converted to T-scores allowing comparisons to a general population.
Measured: 6 months
FAC
Functional Ambulation Categories - categorical scale ranging from 0 (unable to walk) to 5 (independent walking without assistive devices on any surfaces).
Measured: 6 months
Hand grip force
hand grip
Measured: 6 months
Shoulder elevation test
shoulder range of motion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start4 Jan 2021
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
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.
- 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
- Factorial
- Model description
- Consecutive cohort study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vetrea Terveys Oy
- Sponsor type
- University, hospital or other
- Collaborators
- Kuopio University Hospital, City of Kuopio
- Responsible party
- Principal investigator, Kauko Pitkänen, Vetrea Terveys Oy
- Investigators
- Kauko Pitkänen, MD, PhD, Study director, Vetrea Terveys Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647812
- Sponsor's protocol ID
- Taku2020
- Status last verified
- Apr 2021
- First submitted
- 30 Nov 2020
- Last updated
- 19 Apr 2021
- 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 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-assisted Rehabilitation After Acute Stroke
- ClinicalTrials.gov ID
- NCT04647812
- Acronym / sponsor ID
- Taku2020
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vetrea Terveys OyUniversity, hospital or other
- Collaborators
- Kuopio University Hospital, City of Kuopio
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 1 Dec 2020 (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 aim of the study is to evaluate the effects and costs of an intensified rehabilitation for stroke patients. Using novel technologies the patients will receive an augmented exercise therapy during the first weeks after stroke. The effects on restoration of functions as well as on the costs incurred from social and health care services will be assessed and compared to the conventional rehabilitation over 6 month follow-up.
Detailed description
The intervention consists of technology-assisted multidisciplinary rehabilitation for 3 weeks followed by an 8-week period of supervised home-based telerehabilitation and a weekly group exercise in an outpatient clinic. The effects on mobility, upper extremity motor functions and activities of daily living will be assessed using FAC, hand grip force, shoulder elevation test, WHODAS 2.0 and PROMIS scales. The costs incurred from social and health care services over 6 months will be compared to the control group receiving conventional rehabilitation. Patients aged 18 or more with their first stroke and stable cardiopulmonary condition will be consecutively recruited first into the control group (n=20) and thereafter into the experimental group (n=20). Patients with a severe cognitive deficit or aphasia will be excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Consecutive cohort study
| Arm | Type | Receives |
|---|---|---|
| Technology-assisted rehabilitation | Experimental | Behavioral: Technology-assisted rehabilitationAugmented exercise therapy with novel technology |
| Conventional rehabilitation | Experimental | Behavioral: Conventional rehabilitationTraditional multidisciplinary rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 or more
- first stroke
Key exclusion criteria (3 listed)
- unstable cardiopulmonary condition
- severe cognitive disorder
- aphasia
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 |
|---|---|---|
| Technology-assisted rehabilitationAugmented exercise therapy with novel technology and home-based telerehabilitation | Behavioural | Technology-assisted rehabilitation |
| Conventional rehabilitationTraditional multidisciplinary in-patient rehabilitation | Behavioural | Conventional rehabilitation |
Primary outcome
WHODAS 2.0
Time frame: 6 months
World Health Organization Disability Assessment Schedule - 12 questions scoring 1 to 5 yielding a total score from 12 to 60. A higher score means an increasing disability.
service use and costs
Time frame: 6 months
amount and costs of social and health care services used
4 secondary outcomes
PROMIS Global 10
Time frame: 6 months
FAC
Time frame: 6 months
Hand grip force
Time frame: 6 months
Shoulder elevation test
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
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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 Pitkänen, MD, PhD study director
Vetrea Terveys Oy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-assisted rehabilitation and Conventional rehabilitation in people with Stroke, 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 2 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 19 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kauko Pitkänen, MD, PhD (0505965289 ext. 358, kauko.pitkanen@vetrea.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHODAS 2.0 (time frame: 6 months). 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 19 Apr 2021.