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Completed

NCT Number: NCT04069767

Innovative Physiotherapy in Stroke Rehabilitation

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.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhagic Stroke Ischemic Stroke Nervous System Diseases Stroke Stroke Hemorrhagic Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nordlandssykehuset HF, Bodø, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICoreDIST

Procedure

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.

Standard care

Procedure

According to national guidelines for stroke care, every patient in Norway will receive in-patient rehabilitation, home-based and out-patient based physiotherapy.

Primary outcomes

  1. 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

  2. ActiGraph WgtX-BT

    Time frame: 13 weeks

    Accelerometer recording levels of physical activity and number of steps

Secondary outcomes

  1. 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.

  2. MiniBESTest

    Time frame: 12 weeks

    Validated scale to measure pro-and reactive balance in standing and walking

  3. Bodyfitter seat sensor system

    Time frame: 12 weeks

    Pressure mat to register distribution of weight during sitting

  4. Amti Force Platform

    Time frame: 12 weeks

    Device to register postural sway in standing

  5. 10 meter walk test

    Time frame: 12 weeks

    Validated test to assess walking speed

  6. 2 minute walk test

    Time frame: 12 weeks

    Validated test to assess walking distance

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Nordlandssykehuset HF

Other

Collaborators

  • Helse Nord
  • Helse Nord-Trøndelag HF
  • Nord University
  • University of Illinois at Chicago
  • University of the Basque Country (UPV/EHU)

Registry information

Official study title

Innovative Physiotherapy in Stroke Rehabilitation During the Subacute Stage - a Prospective Randomized Single Blinded Controlled Trial and a Qualitative Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2019
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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