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Innovative Physiotherapy in Stroke Rehabilitation

Primary Purpose

Stroke, Ischemic, Stroke Hemorrhagic

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
ICoreDIST
Standard Care
Sponsored by
Nordlandssykehuset HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Physiotherapy, Rehabilitation, Trunk Stability, Stroke, Sub-acute, Innovative, Randomized controlled trial, Qualitative study, Gait, Balance

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Nordlandssykehuset HF
  • Sykehuset Levanger

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ICoreDIST

Standard Care

Arm 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.

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

Outcomes

Primary Outcome Measures

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
ActiGraph WgtX-BT
Accelerometer recording levels of physical activity and number of steps

Secondary Outcome Measures

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

Full Information

First Posted
August 23, 2019
Last Updated
September 27, 2022
Sponsor
Nordlandssykehuset HF
Collaborators
Helse Nord-Trøndelag HF, Nord University, University of Illinois at Chicago, University of the Basque Country (UPV/EHU), Helse Nord
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1. Study Identification

Unique Protocol Identification Number
NCT04069767
Brief Title
Innovative Physiotherapy in Stroke Rehabilitation
Official Title
Innovative Physiotherapy in Stroke Rehabilitation During the Subacute Stage - a Prospective Randomized Single Blinded Controlled Trial and a Qualitative Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
December 5, 2021 (Actual)
Study Completion Date
December 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordlandssykehuset HF
Collaborators
Helse Nord-Trøndelag HF, Nord University, University of Illinois at Chicago, University of the Basque Country (UPV/EHU), Helse Nord

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Stroke Hemorrhagic
Keywords
Physiotherapy, Rehabilitation, Trunk Stability, Stroke, Sub-acute, Innovative, Randomized controlled trial, Qualitative study, Gait, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a parallel trial. After baseline assessment, the participants will be randomly assigned to one of two trial arms, A and B, in a 1:1 ratio.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICoreDIST
Arm Type
Experimental
Arm 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.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Consists of standard inpatient rehabilitation, home-based and outpatient-based physiotherapy with the same dose as the intervention group.
Intervention Type
Procedure
Intervention Name(s)
ICoreDIST
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard Care
Intervention Description
According to national guidelines for stroke care, every patient in Norway will receive in-patient rehabilitation, home-based and out-patient based physiotherapy.
Primary Outcome Measure Information:
Title
Trunk Impairment Scale Norwegian Version
Description
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
Time Frame
12 weeks
Title
ActiGraph WgtX-BT
Description
Accelerometer recording levels of physical activity and number of steps
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Swedish Postural Assessment Scale For Stroke Norwegian Version
Description
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.
Time Frame
12 weeks
Title
MiniBESTest
Description
Validated scale to measure pro-and reactive balance in standing and walking
Time Frame
12 weeks
Title
Bodyfitter seat sensor system
Description
Pressure mat to register distribution of weight during sitting
Time Frame
12 weeks
Title
Amti Force Platform
Description
Device to register postural sway in standing
Time Frame
12 weeks
Title
10 meter walk test
Description
Validated test to assess walking speed
Time Frame
12 weeks
Title
2 minute walk test
Description
Validated test to assess walking distance
Time Frame
12 weeks
Title
EQ-5D-3L
Description
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.
Time Frame
12 weeks
Title
Stroke Specific Quality of Life Scale
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petter Øien
Organizational Affiliation
Nordlandssykehuset HF
Official's Role
Study Director
Facility Information:
Facility Name
Nordlandssykehuset HF
City
Bodø
ZIP/Postal Code
8009
Country
Norway
Facility Name
Sykehuset Levanger
City
Levanger
ZIP/Postal Code
7600
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
34184251
Citation
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.
Results Reference
derived

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Innovative Physiotherapy in Stroke Rehabilitation

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