StrokeSunRISeNCT02717715
SunRISe Study - Stroke Rehabilitation In Suriname
A study testing Home base stroke rehabilitation in people with Stroke, run by KU Leuven at 1 site in Suriname.
Trial summary
This study aims to determine the effect of a supervised home-based physical fitness program on the aerobic capacity, quality of gait and health related quality of life in people with chronic ischemic stroke. Secondly, feasibility of the program for implementing a long term lifestyle change will be investigated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Home base stroke rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSuriname
- Study dates
- Mar 2016to Apr 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ability to give informed consent
- ability to understand measurement procedures defined as MMSE >24
- last stroke >6 months ago
- mild to moderate stroke deficit defined by Fugl Meyer test score of 27 to 90 for upper and lower extremities
- FAC ≥3
- medical clearance to participate in a moderate exercise program
- living at home and having a minimum of 5 stairs at home
Who cannot join
- serious cardiac condition
- other serious end organ damage
- other neurological deficits leading to disability
- uncontrolled blood pressure (systolic pressure >140, diastolic pressure >90)
Trial locations and contacts
1 site in 1 country.
Suriname1 site
Anton De Kom University
Paramaribo
About this study
Official title: The Effect of a Tele-supervised Home Based Rehabilitation Program on Physical Fitness, Quality of Gait, Upper Limb Disability and Quality of Life in People After Chronic Stroke in a Urban Setting in Suriname. Randomised Controlled Trial.
This study aims to determine the effect of a supervised home-based physical fitness program on the aerobic capacity, quality of gait and health related quality of life in people with chronic ischemic stroke. Secondly, feasibility of the program for implementing a long term lifestyle change will be investigated.
- Conditions
- Stroke
- Being tested
- Home base stroke rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home base stroke rehabilitationBehavioural
The intervention consists of physiotherapy exercises targeting functional and physical capacity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Stroke patients from the intervention group will be, on top of usual care, offered a holistic home based and semi-supervised stroke rehabilitation program followed by a period of tele-supervision. Receives: Behavioral: Home base stroke rehabilitation |
| Control group | No intervention | The participants in the control group will only receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak oxygen uptake
Measured: 4 weeks, 8 weeks and 5 months after start of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2017
- Study completionApr 2017
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.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Anton De Kom University, VU University of Amsterdam
- Responsible party
- Principal investigator, Roselien Buys, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717715
- Sponsor's protocol ID
- VG 023-15
- Acronym
- SunRISe
- Status last verified
- Jul 2017
- First submitted
- 5 Mar 2016
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Tele-supervised Home Based Rehabilitation Program on Physical Fitness, Quality of Gait, Upper Limb Disability and Quality of Life in People After Chronic Stroke in a Urban Setting in Suriname. Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT02717715
- Acronym / sponsor ID
- SunRISe / VG 023-15
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Anton De Kom University, VU University of Amsterdam
- Study start
- Mar 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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.
This study aims to determine the effect of a supervised home-based physical fitness program on the aerobic capacity, quality of gait and health related quality of life in people with chronic ischemic stroke. Secondly, feasibility of the program for implementing a long term lifestyle change will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Home base stroke rehabilitationStroke patients from the intervention group will be, on top of usual care, offered a holistic home based and semi-supervised stroke rehabilitation program followed by a period of tele-supervision. |
| Control group | No intervention | –The participants in the control group will only receive usual care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- ability to give informed consent
- ability to understand measurement procedures defined as MMSE >24
- last stroke >6 months ago
- mild to moderate stroke deficit defined by Fugl Meyer test score of 27 to 90 for upper and lower extremities
- FAC ≥3
Key exclusion criteria (4 listed)
- serious cardiac condition
- other serious end organ damage
- other neurological deficits leading to disability
- uncontrolled blood pressure (systolic pressure >140, diastolic pressure >90)
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 |
|---|---|---|
| Home base stroke rehabilitationThe intervention consists of physiotherapy exercises targeting functional and physical capacity. | Behavioural | Intervention group |
Primary outcome
Change in peak oxygen uptake
Time frame: 4 weeks, 8 weeks and 5 months after start of rehabilitation
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 19 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home base stroke rehabilitation in people with Stroke, run by KU Leuven at 1 site in Suriname.
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 7 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 19 Jul 2017. 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 Suriname. 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 peak oxygen uptake (time frame: 4 weeks, 8 weeks and 5 months after start of rehabilitation). 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 Jul 2017.