Stroke, IschemicNCT04069767
Innovative Physiotherapy in Stroke Rehabilitation
A study testing ICoreDIST in people with Stroke, Ischemic and Stroke Hemorrhagic, run by Nordlandssykehuset HF at 2 sites in Norway.
Trial summary
The current study has the potential to improve rehabilitation during the subacute phase of a stroke, aiming to reduce the individual's disabilities and risk of falling, enhance health promoting physical activity and independence in ADL. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Ischemic, Stroke Hemorrhagic
- What is being tested?
- ICoreDIST
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesNorway
- Study dates
- 9 Sep 2019to 5 Dec 2021
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A stroke diagnosis
- Can sit for 10 seconds without support
- Age 18-85
- Trunk Impairment Scale-Norwegian version (TIS-NV) < 15
- Pre-stroke modified Ranking Scale (mRS) 0-3
Who cannot join
- Dementia
- Unable to cooperate in physiotherapy
- On-going substance abuse
- Severe co-morbidity preventing rehabilitation, severe neurological diseases such as Parkinson disease, Multiple Sclerosis and brain tumor.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Nordlandssykehuset HF
Bodø, 8009
Sykehuset Levanger
Levanger, 7600
About this study
Official title: Innovative Physiotherapy in Stroke Rehabilitation During the Subacute Stage - a Prospective Randomized Single Blinded Controlled Trial and a Qualitative Study
The current study has the potential to improve rehabilitation during the subacute phase of a stroke, aiming to reduce the individual's disabilities and risk of falling, enhance health promoting physical activity and independence in ADL.
Read the detailed description
The purpose of the RCT is to investigate the effects of an innovative physiotherapy intervention, called I-CoreDIST when applied in comprehensive rehabilitation after discharge from a stroke unit and throughout the rehabilitation chain.The project investigate: 1) effects on postural control and balance in various positions and functional activities. Effects on and level of physical activity, and 2) user's identifications of positive and negative features in content and coordination of physiotherapy integrated in post stroke rehabilitation. Function parameters of balance, gait and levels of physical activity at baseline and at 12 weeks will be compared to those obtained from the standard care group. Semistructured interviews will be conducted to identify patients' perceptions of key positive and negative features of content and coordination of I-CoreDIST and standard care rehabilitation after a stroke.
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic
- Being tested
- ICoreDIST, Standard Care
- Keywords
- Physiotherapy, Rehabilitation, Trunk Stability, Stroke, Sub-acute, Innovative, Randomized controlled trial, Qualitative study, Gait, Balance
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICoreDISTProcedure or surgery
The intervention consists of exercises that demand enhancement of dynamic trunk stability and functional movements, combined with the following:
- Optimised alignment and adaptation to the base of support and often using an unstable reference point for the trunk (therapeutic ball) or the distal body parts.
- Enhanced somatosensory integration of hands, feet and face, including reduced influence of vision to enhance somatosensory integration.
- Proximal stability prior to selective task-oriented movement of limbs, head, eyes.
- Inclusion of dual tasks (motor/motor and motor/cognitive) in exercises and activities such as walking indoors, out-doors and climbing stairs.
- Specific hands-on interactions or other adaptations to optimise alignment and neuromuscular recruitment.
- Exercises combining core activation and moderate increase in heart rate: in lying, sitting, standing and walking.
Standard CareProcedure or surgery
According to national guidelines for stroke care, every patient in Norway will receive in-patient rehabilitation, home-based and out-patient based physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| ICoreDIST | Experimental | The intervention starts with an assessment by the physiotherapist to identify the patient's movement problems in order to choose among the 48 exercises in the intervention. Each session lasts for 60 minutes + exercises 5-10 minutes outside of therapy and is performed 5-6 days/per week in the rehabilitation units, and 3 sessions/week + home exercises 30 minutes 3 days per week in home based or outpatient treatment during the 12 weeks period.To allow for individualisation, each exercise contains five levels of difficulty. All exercises demand enhancement of dynamic trunk stability and functional movements. Receives: Procedure: ICoreDIST |
| Standard Care | Active comparator | Consists of standard inpatient rehabilitation, home-based and outpatient-based physiotherapy with the same dose as the intervention group. Receives: Procedure: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Impairment Scale Norwegian Version
Validated scale to assess dynamic sitting balance. The test consists of ordinal 6 sub scales summed to measure dynamic sitting balance and trunk coordination.The scale ranges from 0-16 points where higher score indicates better sitting balance
Measured: 12 weeks
ActiGraph WgtX-BT
Accelerometer recording levels of physical activity and number of steps
Measured: 13 weeks
Secondary outcomes (8)
Swedish Postural Assessment Scale For Stroke Norwegian Version
PASS is a validated postural assessment scale specifically designed to assess and monitor postural control after stroke. It contains 12 four-level items (0-3 points) of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture. The scale ranges from 0-36 points, sub-items are summed to calculate a total score. Higher score indicates better postural control.
Measured: 12 weeks
MiniBESTest
Validated scale to measure pro-and reactive balance in standing and walking
Measured: 12 weeks
Bodyfitter seat sensor system
Pressure mat to register distribution of weight during sitting
Measured: 12 weeks
Amti Force Platform
Device to register postural sway in standing
Measured: 12 weeks
10 meter walk test
Validated test to assess walking speed
Measured: 12 weeks
2 minute walk test
Validated test to assess walking distance
Measured: 12 weeks
EQ-5D-3L
Survey to assess self-perceived quality of life. The EQ-5D-3L comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: 12 weeks
Stroke Specific Quality of Life Scale
Survey to assess self-perceived quality of life. Stroke-Specific Quality-of-Life (SSQOL) scale is designed to measure multiple effects in poststroke patients. The scale consists of 49 questions grouped into 12 domains. Each domain is assessed on 5-point Gutterman type scales. Provides both summary and domain-specific scores. Domain scores are composed of unweighted averages. Summary scores are composed of an unweighted average of the 12 domain average scores. Scores range from 49-245 and higher scores indicate better functioning.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start9 Sep 2019
- Primary completion5 Dec 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel trial. After baseline assessment, the participants will be randomly assigned to one of two trial arms, A and B, in a 1:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordlandssykehuset HF
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF, Nord University, University of Illinois at Chicago, University of the Basque Country (UPV/EHU), Helse Nord
- Responsible party
- Sponsor
- Investigators
- Petter Øien, Study director, Nordlandssykehuset HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069767
- Sponsor's protocol ID
- StrokeCoreDIST
- Status last verified
- Apr 2022
- First submitted
- 23 Aug 2019
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Normann B, Arntzen EC, Sivertsen M. Comprehensive core stability intervention and coordination of care in acute and subacute stroke rehabilitation-a pilot study. European Journal of Physiotherapy; DOI: 10.1080/21679169.2018.1508497, 2018.
Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.
PubMed 34184251
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Physiotherapy in Stroke Rehabilitation During the Subacute Stage - a Prospective Randomized Single Blinded Controlled Trial and a Qualitative Study
- ClinicalTrials.gov ID
- NCT04069767
- Acronym / sponsor ID
- StrokeCoreDIST
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic
- Keywords
- Physiotherapy, Rehabilitation, Trunk Stability, Stroke, Sub-acute, Innovative, Randomized controlled trial, Qualitative study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nordlandssykehuset HFUniversity, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF, Nord University, University of Illinois at Chicago, University of the Basque Country (UPV/EHU), Helse Nord
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 5 Dec 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 28 Aug 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.
The current study has the potential to improve rehabilitation during the subacute phase of a stroke, aiming to reduce the individual's disabilities and risk of falling, enhance health promoting physical activity and independence in ADL.
Detailed description
The purpose of the RCT is to investigate the effects of an innovative physiotherapy intervention, called I-CoreDIST when applied in comprehensive rehabilitation after discharge from a stroke unit and throughout the rehabilitation chain.The project investigate: 1) effects on postural control and balance in various positions and functional activities. Effects on and level of physical activity, and 2) user's identifications of positive and negative features in content and coordination of physiotherapy integrated in post stroke rehabilitation. Function parameters of balance, gait and levels of physical activity at baseline and at 12 weeks will be compared to those obtained from the standard care group. Semistructured interviews will be conducted to identify patients' perceptions of key positive and negative features of content and coordination of I-CoreDIST and standard care rehabilitation after a stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel trial. After baseline assessment, the participants will be randomly assigned to one of two trial arms, A and B, in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| ICoreDIST | Experimental | Procedure: ICoreDISTThe intervention starts with an assessment by the physiotherapist to identify the patient's movement problems in order to choose among the 48 exercises in the intervention. Each session lasts for 60 minutes + exercises 5-10 minutes outside of therapy and is performed 5-6 days/per week in the rehabilitation units, and 3 sessions/week + home exercises 30 minutes 3 days per week in home based or outpatient treatment during the 12 weeks period.To allow for individualisation, each exercise contains five levels of difficulty. All exercises demand enhancement of dynamic trunk stability and functional movements. |
| Standard Care | Active comparator | Procedure: Standard CareConsists of standard inpatient rehabilitation, home-based and outpatient-based physiotherapy with the same dose as the intervention group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A stroke diagnosis
- Can sit for 10 seconds without support
- Age 18-85
- Trunk Impairment Scale-Norwegian version (TIS-NV) < 15
- Pre-stroke modified Ranking Scale (mRS) 0-3
Key exclusion criteria (4 listed)
- Dementia
- Unable to cooperate in physiotherapy
- On-going substance abuse
- Severe co-morbidity preventing rehabilitation, severe neurological diseases such as Parkinson disease, Multiple Sclerosis and brain tumor.
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 |
|---|---|---|
| ICoreDISTThe intervention consists of exercises that demand enhancement of dynamic trunk stability and functional movements, combined with the following: 1. Optimised alignment and adaptation to the base of support and often using an unstable reference point for the trunk (therapeutic ball) or the distal body parts. 2. Enhanced somatosensory integration of hands, feet and face, including reduced influence of vision to enhance somatosensory integration. 3. Proximal stability prior to selective task-oriented movement of limbs, head, eyes. 4. Inclusion of dual tasks (motor/motor and motor/cognitive) in exercises and activities such as walking indoors, out-doors and climbing stairs. 5. Specific hands-on interactions or other adaptations to optimise alignment and neuromuscular recruitment. 6. Exercises combining core activation and moderate increase in heart rate: in lying, sitting, standing and walking. | Procedure or surgery | ICoreDIST |
| Standard CareAccording to national guidelines for stroke care, every patient in Norway will receive in-patient rehabilitation, home-based and out-patient based physiotherapy. | Procedure or surgery | Standard Care |
Primary outcome
Trunk Impairment Scale Norwegian Version
Time frame: 12 weeks
Validated scale to assess dynamic sitting balance. The test consists of ordinal 6 sub scales summed to measure dynamic sitting balance and trunk coordination.The scale ranges from 0-16 points where higher score indicates better sitting balance
ActiGraph WgtX-BT
Time frame: 13 weeks
Accelerometer recording levels of physical activity and number of steps
8 secondary outcomes
Swedish Postural Assessment Scale For Stroke Norwegian Version
Time frame: 12 weeks
MiniBESTest
Time frame: 12 weeks
Bodyfitter seat sensor system
Time frame: 12 weeks
Amti Force Platform
Time frame: 12 weeks
10 meter walk test
Time frame: 12 weeks
2 minute walk test
Time frame: 12 weeks
EQ-5D-3L
Time frame: 12 weeks
Stroke Specific Quality of Life Scale
Time frame: 1 day
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 28 Sep 2022.
- BackgroundNormann B, Arntzen EC, Sivertsen M. Comprehensive core stability intervention and coordination of care in acute and subacute stroke rehabilitation-a pilot study. European Journal of Physiotherapy; DOI: 10.1080/21679169.2018.1508497, 2018.
- Derived from this study: PubMed 34184251Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.
- Individual participant dataSharing planned: No
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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.
Petter Øien study director
Nordlandssykehuset HF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICoreDIST in people with Stroke, Ischemic and Stroke Hemorrhagic, run by Nordlandssykehuset HF at 2 sites in Norway.
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 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Trunk Impairment Scale Norwegian Version (time frame: 12 weeks). 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?
On the ClinicalTrials.gov record for NCT04069767, which also lists 2 linked publications.
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 28 Sep 2022.