Innovative Physiotherapy in Stroke Rehabilitation
1 other identifier
interventional
60
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedStudy Start
First participant enrolled
September 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2021
CompletedSeptember 28, 2022
April 1, 2022
2.2 years
August 23, 2019
September 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
12 weeks
ActiGraph WgtX-BT
Accelerometer recording levels of physical activity and number of steps
13 weeks
Secondary Outcomes (8)
Swedish Postural Assessment Scale For Stroke Norwegian Version
12 weeks
MiniBESTest
12 weeks
Bodyfitter seat sensor system
12 weeks
Amti Force Platform
12 weeks
10 meter walk test
12 weeks
- +3 more secondary outcomes
Study Arms (2)
ICoreDIST
EXPERIMENTALThe 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 COMPARATORConsists of standard inpatient rehabilitation, home-based and outpatient-based physiotherapy with the same dose as the intervention group.
Interventions
The 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.
According to national guidelines for stroke care, every patient in Norway will receive in-patient rehabilitation, home-based and out-patient based physiotherapy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nordlandssykehuset HFlead
- Helse Nord-Trøndelag HFcollaborator
- Nord Universitycollaborator
- University of Illinois at Chicagocollaborator
- University of the Basque Country (UPV/EHU)collaborator
- Helse Nordcollaborator
Study Sites (2)
Nordlandssykehuset HF
Bodø, 8009, Norway
Sykehuset Levanger
Levanger, 7600, Norway
Related Publications (2)
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.
BACKGROUNDSaunders 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.
PMID: 34184251DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Petter Øien
Nordlandssykehuset HF
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2019
First Posted
August 28, 2019
Study Start
September 9, 2019
Primary Completion
December 5, 2021
Study Completion
December 5, 2021
Last Updated
September 28, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share