Clinical trial NCT04069767: Innovative Physiotherapy in Stroke Rehabilitation
Official title: Innovative Physiotherapy in Stroke Rehabilitation During the Subacute Stage - a Prospective Randomized Single Blinded Controlled Trial and a Qualitative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Stroke Hemorrhagic
Keywords: Physiotherapy
Rehabilitation
Trunk Stability
Stroke
Sub-acute
Innovative
Randomized controlled trial
Qualitative study
Gait
Balance
Lead sponsor: Nordlandssykehuset HF
Sponsor class: OTHER
Collaborators: name: Helse Nord-Trøndelag HF
name: Nord University
name: University of Illinois at Chicago
name: University of the Basque Country (UPV/EHU)
name: Helse Nord
First posted: 2019-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Trunk Impairment Scale Norwegian Version
timeFrame: 12 weeks
measure: ActiGraph WgtX-BT
timeFrame: 13 weeks
Secondary outcomes:
measure: Swedish Postural Assessment Scale For Stroke Norwegian Version
timeFrame: 12 weeks
measure: MiniBESTest
timeFrame: 12 weeks
measure: Bodyfitter seat sensor system
timeFrame: 12 weeks
measure: Amti Force Platform
timeFrame: 12 weeks
measure: 10 meter walk test
timeFrame: 12 weeks
measure: 2 minute walk test
timeFrame: 12 weeks
measure: EQ-5D-3L
timeFrame: 12 weeks
measure: Stroke Specific Quality of Life Scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Nordlandssykehuset HF
city: Levanger
country: Norway
facility: Sykehuset Levanger
Study officials:
affiliation: Nordlandssykehuset HF
name: Petter Øien
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.