Clinical trial NCT04870619: FIRST-Oslo Long-term Follow-up
Official title: FOCUSED INTENSIVE REPETITIVE STEP TRAINING - Long-term Follow-up of High Intensity Stepping Training After Stroke in Oslo (FIRST-Oslo - Long-term)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: High Intensity Gait Training
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Indiana University School of Medicine
name: Norwegian Fund for Postgraduate Training in Physiotherapy
name: City of Oslo
name: Sunnaas Rehabilitation Hospital
First posted: 2021-05-03
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Two separate inpatient rehabilitation units in Oslo will participate in the study - OUH's rehabilitation unit and OMS' rehabilitation unit, both at Aker campus.

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.

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

Primary outcomes:
measure: 10 meter walk test
timeFrame: 12 months
measure: 6-minute walk test
timeFrame: 12 months
measure: Berg balance scale
timeFrame: 12 months
measure: Steps
timeFrame: Daily through stay, average of 3 weeks
measure: Intensity
timeFrame: Each PT session trough stay, and average of 3 weeks
Secondary outcomes:
measure: Sit-to-stand x5
timeFrame: 3 weeks
measure: Sit-to-stand x5
timeFrame: 3 months
measure: Sit-to-stand x5
timeFrame: 6 months
measure: Sit-to-stand x5
timeFrame: 12 months
measure: Manual muscle testing
timeFrame: 3 weeks
measure: Manual muscle testing
timeFrame: 3 months
measure: Manual muscle testing
timeFrame: 6 months
measure: Manual muscle testing
timeFrame: 12 months
measure: Action-Research-Arm-Test (ARAT)
timeFrame: Weekly during inpatient stay, in average 3 weeks
measure: Action-Research-Arm-Test (ARAT)
timeFrame: 3 weeks
measure: Action-Research-Arm-Test (ARAT)
timeFrame: 3 months
measure: Action-Research-Arm-Test (ARAT)
timeFrame: 6 months
measure: Action-Research-Arm-Test (ARAT)
timeFrame: 12 months
measure: EQ-5D-5L
timeFrame: 3 weeks
measure: EQ-5D-5L
timeFrame: 3 months
measure: EQ-5D-5L
timeFrame: 6 months
measure: EQ-5D-5L
timeFrame: 12 months
measure: PROMIS
timeFrame: 3 weeks
measure: PROMIS
timeFrame: 3 months
measure: PROMIS
timeFrame: 6 months
measure: PROMIS
timeFrame: 12 months
measure: 10 meter walk test
timeFrame: Weekly through stay, average of 3 weeks
measure: 10 meter walk test
timeFrame: 3 weeks
measure: 10 meter walk test
timeFrame: 3 months
measure: 10 meter walk test
timeFrame: 6 months
measure: 6 minute walk test
timeFrame: Weekly through stay, average of 3 weeks
measure: 6 minute walk test
timeFrame: 3 weeks
measure: 6 minute walk test
timeFrame: 3 months
measure: 6 minute walk test
timeFrame: 6 months
measure: Berg balance scale
timeFrame: Weekly through stay, average of 3 weeks
measure: Berg balance scale
timeFrame: 3 weeks
measure: Berg balance scale
timeFrame: 3 months
measure: Berg balance scale
timeFrame: 6 months
measure: MiniBESTest
timeFrame: Weekly through stay, average of 3 weeks
measure: MiniBESTest
timeFrame: 3 weeks
measure: MiniBESTest
timeFrame: 3 months
measure: MiniBESTest
timeFrame: 6 months
measure: MiniBESTest
timeFrame: 12 months
measure: Patient Satisfaction with treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Oslo
country: Norway
facility: Oslo municipality - Enhanced Rehabilitation Aker
Study officials:
affiliation: Oslo Univeristy Hospital
name: Elisabeth Bø, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.