Innovative Physiotherapy in Stroke Rehabilitation

Nordlandssykehuset HF

Status: Completed

Conditions: Stroke Hemorrhagic; Stroke, Ischemic

Treatments: Procedure: Standard Care; Procedure: ICoreDIST

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04069767

StrokeCoreDIST

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

ICoreDIST

Experimental group

Description:

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.

Treatment:

Procedure: ICoreDIST

Standard Care

Active Comparator group

Description:

Consists of standard inpatient rehabilitation, home-based and outpatient-based physiotherapy with the same dose as the intervention group.

Treatment:

Procedure: Standard Care