Innovative Physiotherapy in Stroke Rehabilitation

Not Applicable

Completed

• Conditions: Stroke, Ischemic; Stroke Hemorrhagic
• Interventions: Procedure: ICoreDIST; Procedure: Standard Care

• Registration Number: NCT04069767
• Lead Sponsor: Nordlandssykehuset HF

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.

Study Timeline

• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Study Start: 2019-09-09
• Primary Completion: 2021-12-05
• Study Completion: 2021-12-05
• Status Verified: 2022-04
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICoreDIST	ICoreDIST	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.
Standard Care	Standard Care	Consists of standard inpatient rehabilitation, home-based and outpatient-based physiotherapy with the same dose as the intervention group.

Primary Outcome Measures

Name	Time	Method
Trunk Impairment Scale Norwegian Version	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	13 weeks	Accelerometer recording levels of physical activity and number of steps

Secondary Outcome Measures

Name	Time	Method
Swedish Postural Assessment Scale For Stroke Norwegian Version	12 weeks	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.
MiniBESTest	12 weeks	Validated scale to measure pro-and reactive balance in standing and walking
Bodyfitter seat sensor system	12 weeks	Pressure mat to register distribution of weight during sitting
Amti Force Platform	12 weeks	Device to register postural sway in standing
10 meter walk test	12 weeks	Validated test to assess walking speed
2 minute walk test	12 weeks	Validated test to assess walking distance
EQ-5D-3L	12 weeks	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.
Stroke Specific Quality of Life Scale	1 day	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.

Trial Locations

Locations (2)

Sykehuset Levanger; 🇳🇴 Levanger, Norway

Nordlandssykehuset HF; 🇳🇴 Bodø, Norway