Skip to content

FIRST-Oslo Long-term Follow-up

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04870619
Enrollment
69
Registered
2021-05-03
Start date
2021-06-20
Completion date
2023-09-04
Last updated
2023-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

High Intensity Gait Training

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.

Interventions

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.

Sponsors

Indiana University School of Medicine
CollaboratorOTHER
Norwegian Fund for Postgraduate Training in Physiotherapy
CollaboratorOTHER
City of Oslo
CollaboratorUNKNOWN
Sunnaas Rehabilitation Hospital
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
10 meter walk test12 monthsWalking speed
6-minute walk test12 monthsWalking distance
Berg balance scale12 monthsBalance measured on a scale 0-56 points, higher scores mean a better outcome
StepsDaily through stay, average of 3 weeksNumber of Steps
IntensityEach PT session trough stay, and average of 3 weeksHeart Rate during training

Secondary

MeasureTime frameDescription
10 meter walk testWeekly through stay, average of 3 weeksWalking speed, time in m/sec
6 minute walk testWeekly through stay, average of 3 weeksWalking distance in meters
Sit-to-stand x53 weeksFunctional strength, time to complete in sec
MiniBESTestWeekly through stay, average of 3 weeksBalance measured on a scale 0-28, higher scores indicate a better outcome
Patient Satisfaction with treatment12 months6 questions on satisfaction with treatment, Likert scale,
Berg balance scaleWeekly through stay, average of 3 weeksBalance measured on a scale 0-56 points, higher scores indicate a better outcome
Manual muscle testing3 weeksStrength of lower extremities, ordinal scale 0-5, higher score indicate better outcome
Action-Research-Arm-Test (ARAT)Weekly during inpatient stay, in average 3 weeksEvaluation tool for motot function in the upper extremity after neurological injuries. Ordinal scale 0-57, higher score indicate better outcome
EQ-5D-5L3 weeksHealth related quality of life
PROMIS3 weeksHealth related quality of life

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026