FIRST-Oslo Long-term Follow-up

NCT ID: NCT04870619

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-20

Study Completion Date

2023-09-04

Brief Summary

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The study aims to describe the functional level of the patients who received high intensity gait training during inpatient stroke rehabilitation at discharge, three, six and twelve months after stroke. These data will determine if the observed gains from the high-intensity gait training are retained after discharge from inpatient rehabilitation.

Detailed Description

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The study is a cohort-study that will have a prospective observational design. This design allows us to follow patients who presently have had a stroke and received high intensity stepping training over time. At this time little is known about the patient's functional trajectory the first 12 months after receiving high intensity stepping treatment as no study has examined long-term effects of high-intensity stepping training delivered in inpatient rehabilitation for stroke in Norway nor internationally.

Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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High Intensity Gait Training

The intervention provided in this project is routinely delivered as a standard of care at the participating sites for patients after stroke that have a goal of walking improvement. The intervention consists of 45-60 minute, physical therapy sessions that occur five days per week (not weekends), focusing on prioritizing stepping practice at higher aerobic intensities during scheduled treatments (target training zone of 70-85% heart rate max (HRmax). Stepping is performed on treadmills and over ground, with safety harness systems and body weight support only as needed to ensure successful stepping. Tasks are progressed by increasing task difficulty as determined by the therapist. Accordingly, practice of non-walking tasks performed during physiotherapy, including bed mobility, transfers, and standing balance/ pre-gait activities, is limited.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults (\>18 years old) who are receiving inpatient rehabilitation for stroke
* \< six months post-stroke
* have the goal to improve walking function
* provide written consent will participate in the study.

Exclusion Criteria

* inability to consent
* use of bracing or instrumentation (e.g. ventilator) that limits walking
* independence in walking outdoors and on stairs (Functional Ambulation Category (FAC) at admission = 5)
* uncontrolled cardiopulmonary, metabolic, infectious or psychiatric disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University School of Medicine

OTHER

Sponsor Role collaborator

Norwegian Fund for Postgraduate Training in Physiotherapy

OTHER

Sponsor Role collaborator

City of Oslo

UNKNOWN

Sponsor Role collaborator

Sunnaas Rehabilitation Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elisabeth Bø

Physiotherapist PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elisabeth Bø, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo Univeristy Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Oslo municipality - Enhanced Rehabilitation Aker

Oslo, , Norway

Site Status

Countries

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Norway

References

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Moore JL, Nordvik JE, Erichsen A, Rosseland I, Bo E, Hornby TG; FIRST-Oslo Team. Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes. Stroke. 2020 Feb;51(2):563-570. doi: 10.1161/STROKEAHA.119.027450. Epub 2019 Dec 30.

Reference Type RESULT
PMID: 31884902 (View on PubMed)

Other Identifiers

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216346

Identifier Type: -

Identifier Source: org_study_id

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