Innovative Physiotherapy in Stroke Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Ischemic; Stroke Hemorrhagic
• Intervention / Treatment: Procedure: ICoreDIST; Procedure: Standard Care

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bodø, Norway, 8009
    • Nordlandssykehuset HF
  • Levanger, Norway, 7600
    • Sykehuset Levanger

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: ICoreDIST; 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.
Active Comparator: Standard Care; Consists of standard inpatient rehabilitation, home-based and outpatient-based physiotherapy with the same dose as the intervention group.	Procedure: Standard Care; According to national guidelines for stroke care, every patient in Norway will receive in-patient rehabilitation, home-based and out-patient based physiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
MiniBESTest	Validated scale to measure pro-and reactive balance in standing and walking	12 weeks
Bodyfitter seat sensor system	Pressure mat to register distribution of weight during sitting	12 weeks
Amti Force Platform	Device to register postural sway in standing	12 weeks
10 meter walk test	Validated test to assess walking speed	12 weeks
2 minute walk test	Validated test to assess walking distance	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.	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.	1 day

Collaborators and Investigators

• Sponsor: Nordlandssykehuset HF
• Collaborators: University of Illinois at Chicago; University of the Basque Country (UPV/EHU); Helse Nord-Trøndelag HF; Helse Nord; Nord University
• Investigators: Study Director: Petter Øien, Nordlandssykehuset HF

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): December 5, 2021
• Study Completion (Actual): December 5, 2021

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Balance; Stroke; Gait; Randomized controlled trial; Physiotherapy; Qualitative study; Trunk Stability; Sub-acute; Innovative
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Hemorrhagic Stroke
• Other Study ID Numbers: StrokeCoreDIST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No