Innovative Physiotherapy in Stroke Rehabilitation

Overview

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 Title of Study: “Innovative Physiotherapy in Stroke Rehabilitation During the Subacute Stage – a Prospective Randomized Single Blinded Controlled Trial and a Qualitative Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 5, 2021

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: Standard Care
    • Consists of standard inpatient rehabilitation, home-based and outpatient-based physiotherapy with the same dose as the intervention group.

Clinical Trial Outcome Measures

Primary Measures

  • Trunk Impairment Scale Norwegian Version
    • Time Frame: 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
    • Time Frame: 13 weeks
    • Accelerometer recording levels of physical activity and number of steps

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nordlandssykehuset HF
  • Collaborator
    • Helse Nord-Trøndelag HF
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Petter Øien, Study Director, Nordlandssykehuset HF

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.