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Clinical Trials/NCT04069767
NCT04069767
Completed
Not Applicable

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

Nordlandssykehuset HF2 sites in 1 country60 target enrollmentSeptember 9, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Ischemic
Sponsor
Nordlandssykehuset HF
Enrollment
60
Locations
2
Primary Endpoint
Trunk Impairment Scale Norwegian Version
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 9, 2019
End Date
December 5, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

  • 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.

Outcomes

Primary Outcomes

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 Outcomes

  • 10 meter walk test(12 weeks)
  • Swedish Postural Assessment Scale For Stroke Norwegian Version(12 weeks)
  • MiniBESTest(12 weeks)
  • Bodyfitter seat sensor system(12 weeks)
  • 2 minute walk test(12 weeks)
  • Amti Force Platform(12 weeks)
  • EQ-5D-3L(12 weeks)
  • Stroke Specific Quality of Life Scale(1 day)

Study Sites (2)

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