FIRST-Oslo Long-term Follow-up

November 1, 2023 updated by: Elisabeth Bø, Oslo University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Norway
      • Oslo, Norway, 0514
        • Oslo University Hospital
      • Oslo, Norway
        • Oslo municipality - Enhanced Rehabilitation Aker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
10 meter walk test
Time Frame: 12 months
Walking speed
12 months
6-minute walk test
Time Frame: 12 months
Walking distance
12 months
Berg balance scale
Time Frame: 12 months
Balance measured on a scale 0-56 points, higher scores mean a better outcome
12 months
Steps
Time Frame: Daily through stay, average of 3 weeks
Number of Steps
Daily through stay, average of 3 weeks
Intensity
Time Frame: Each PT session trough stay, and average of 3 weeks
Heart Rate during training
Each PT session trough stay, and average of 3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sit-to-stand x5
Time Frame: 3 weeks
Functional strength, time to complete in sec
3 weeks
Sit-to-stand x5
Time Frame: 3 months
Functional strength, time to complete in sec
3 months
Sit-to-stand x5
Time Frame: 6 months
Functional strength, time to complete in sec
6 months
Sit-to-stand x5
Time Frame: 12 months
Functional strength, time to complete in sec
12 months
Manual muscle testing
Time Frame: 3 weeks
Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome
3 weeks
Manual muscle testing
Time Frame: 3 months
Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome
3 months
Manual muscle testing
Time Frame: 6 months
Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome
6 months
Manual muscle testing
Time Frame: 12 months
Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome
12 months
Action-Research-Arm-Test (ARAT)
Time Frame: Weekly during inpatient stay, in average 3 weeks
Evaluation tool for motot function in the upper extremity after neurological injuries. Ordinal scale 0-57, higher score indicate better outcome
Weekly during inpatient stay, in average 3 weeks
Action-Research-Arm-Test (ARAT)
Time Frame: 3 weeks
Evaluation tool for motot function in the upper extremity after neurological injuries. Ordinal scale 0-57, higher score indicate better outcome
3 weeks
Action-Research-Arm-Test (ARAT)
Time Frame: 3 months
Evaluation tool for motot function in the upper extremity after neurological injuries. Ordinal scale 0-57, higher score indicate better outcome
3 months
Action-Research-Arm-Test (ARAT)
Time Frame: 6 months
Evaluation tool for motot function in the upper extremity after neurological injuries. Ordinal scale 0-57, higher score indicate better outcome
6 months
Action-Research-Arm-Test (ARAT)
Time Frame: 12 months
Evaluation tool for motot function in the upper extremity after neurological injuries. Ordinal scale 0-57, higher score indicate better outcome
12 months
EQ-5D-5L
Time Frame: 3 weeks
Health related quality of life
3 weeks
EQ-5D-5L
Time Frame: 3 months
Health related quality of life
3 months
EQ-5D-5L
Time Frame: 6 months
Health related quality of life
6 months
EQ-5D-5L
Time Frame: 12 months
Health related quality of life
12 months
PROMIS
Time Frame: 3 weeks
Health related quality of life
3 weeks
PROMIS
Time Frame: 3 months
Health related quality of life
3 months
PROMIS
Time Frame: 6 months
Health related quality of life
6 months
PROMIS
Time Frame: 12 months
Health related quality of life
12 months
10 meter walk test
Time Frame: Weekly through stay, average of 3 weeks
Walking speed, time in m/sec
Weekly through stay, average of 3 weeks
10 meter walk test
Time Frame: 3 weeks
Walking speed, time in m/sec
3 weeks
10 meter walk test
Time Frame: 3 months
Walking speed, time in m/sec
3 months
10 meter walk test
Time Frame: 6 months
Walking speed, time in m/sec
6 months
6 minute walk test
Time Frame: Weekly through stay, average of 3 weeks
Walking distance in meters
Weekly through stay, average of 3 weeks
6 minute walk test
Time Frame: 3 weeks
Walking distance in meters
3 weeks
6 minute walk test
Time Frame: 3 months
Walking distance in meters
3 months
6 minute walk test
Time Frame: 6 months
Walking distance in meters
6 months
Berg balance scale
Time Frame: Weekly through stay, average of 3 weeks
Balance measured on a scale 0-56 points, higher scores indicate a better outcome
Weekly through stay, average of 3 weeks
Berg balance scale
Time Frame: 3 weeks
Balance measured on a scale 0-56 points, higher scores indicate a better outcome
3 weeks
Berg balance scale
Time Frame: 3 months
Balance measured on a scale 0-56 points, higher scores indicate a better outcome
3 months
Berg balance scale
Time Frame: 6 months
Balance measured on a scale 0-56 points, higher scores indicate a better outcome
6 months
MiniBESTest
Time Frame: Weekly through stay, average of 3 weeks
Balance measured on a scale 0-28, higher scores indicate a better outcome
Weekly through stay, average of 3 weeks
MiniBESTest
Time Frame: 3 weeks
Balance measured on a scale 0-28, higher scores indicate a better outcome
3 weeks
MiniBESTest
Time Frame: 3 months
Balance measured on a scale 0-28, higher scores indicate a better outcome
3 months
MiniBESTest
Time Frame: 6 months
Balance measured on a scale 0-28, higher scores indicate a better outcome
6 months
MiniBESTest
Time Frame: 12 months
Balance measured on a scale 0-28, higher scores indicate a better outcome
12 months
Patient Satisfaction with treatment
Time Frame: 12 months
6 questions on satisfaction with treatment, Likert scale,
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sunnaas Rehabilitation Hospital
Indiana University School of Medicine
Norwegian Fund for Postgraduate Training in Physiotherapy
City of Oslo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elisabeth Bø, PhD, Oslo Univeristy Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 216346

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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