Skip to main content
Clinical Trials/NCT04870619
NCT04870619
Completed
Not Applicable

FOCUSED INTENSIVE REPETITIVE STEP TRAINING - Long-term Follow-up of High Intensity Stepping Training After Stroke in Oslo (FIRST-Oslo - Long-term)

Oslo University Hospital2 sites in 1 country69 target enrollmentJune 20, 2021
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Oslo University Hospital
Enrollment
69
Locations
2
Primary Endpoint
6-minute walk test
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 20, 2021
End Date
September 4, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Elisabeth Bø

Physiotherapist PhD

Oslo University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

6-minute walk test

Time Frame: 12 months

Walking distance

Intensity

Time Frame: Each PT session trough stay, and average of 3 weeks

Heart Rate during training

Berg balance scale

Time Frame: 12 months

Balance measured on a scale 0-56 points, higher scores mean a better outcome

Steps

Time Frame: Daily through stay, average of 3 weeks

Number of Steps

10 meter walk test

Time Frame: 12 months

Walking speed

Secondary Outcomes

  • Sit-to-stand x5(12 months)
  • Action-Research-Arm-Test (ARAT)(12 months)
  • 10 meter walk test(6 months)
  • EQ-5D-5L(12 months)
  • Manual muscle testing(12 months)
  • MiniBESTest(12 months)
  • PROMIS(12 months)
  • 6 minute walk test(6 months)
  • Berg balance scale(6 months)
  • Patient Satisfaction with treatment(12 months)

Study Sites (2)

Loading locations...

Similar Trials