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StrokeNCT04870619

FIRST-Oslo Long-term Follow-up

An observational study of Stroke, run by Oslo University Hospital at 2 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
High Intensity Gait Training
How many people
69 participants
Where
2 sitesNorway
Study dates
20 Jun 2021to 4 Sep 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Norway2 sites

  • Oslo University Hospital

    Oslo, 0514

  • Oslo municipality - Enhanced Rehabilitation Aker

    Oslo

Other trials in Norway

About this study

Official title: 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.

Read the 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.

Conditions
Stroke
Being tested
High Intensity Gait Training
Keywords
High Intensity Gait Training
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Intensity Gait TrainingOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 10 meter walk test

    Walking speed

    Measured: 12 months

  2. 6-minute walk test

    Walking distance

    Measured: 12 months

  3. Berg balance scale

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

    Measured: 12 months

  4. Steps

    Number of Steps

    Measured: Daily through stay, average of 3 weeks

  5. Intensity

    Heart Rate during training

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

Secondary outcomes (39)

  1. Sit-to-stand x5

    Functional strength, time to complete in sec

    Measured: 3 weeks

  2. Sit-to-stand x5

    Functional strength, time to complete in sec

    Measured: 3 months

  3. Sit-to-stand x5

    Functional strength, time to complete in sec

    Measured: 6 months

  4. Sit-to-stand x5

    Functional strength, time to complete in sec

    Measured: 12 months

  5. Manual muscle testing

    Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome

    Measured: 3 weeks

  6. Manual muscle testing

    Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome

    Measured: 3 months

  7. Manual muscle testing

    Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome

    Measured: 6 months

  8. Manual muscle testing

    Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome

    Measured: 12 months

  9. Action-Research-Arm-Test (ARAT)

    Evaluation tool for motot function in the upper extremity after neurological injuries. Ordinal scale 0-57, higher score indicate better outcome

    Measured: Weekly during inpatient stay, in average 3 weeks

  10. Action-Research-Arm-Test (ARAT)

    Evaluation tool for motot function in the upper extremity after neurological injuries. Ordinal scale 0-57, higher score indicate better outcome

    Measured: 3 weeks

  11. Action-Research-Arm-Test (ARAT)

    Evaluation tool for motot function in the upper extremity after neurological injuries. Ordinal scale 0-57, higher score indicate better outcome

    Measured: 3 months

  12. Action-Research-Arm-Test (ARAT)

    Evaluation tool for motot function in the upper extremity after neurological injuries. Ordinal scale 0-57, higher score indicate better outcome

    Measured: 6 months

  13. Action-Research-Arm-Test (ARAT)

    Evaluation tool for motot function in the upper extremity after neurological injuries. Ordinal scale 0-57, higher score indicate better outcome

    Measured: 12 months

  14. EQ-5D-5L

    Health related quality of life

    Measured: 3 weeks

  15. EQ-5D-5L

    Health related quality of life

    Measured: 3 months

  16. EQ-5D-5L

    Health related quality of life

    Measured: 6 months

  17. EQ-5D-5L

    Health related quality of life

    Measured: 12 months

  18. PROMIS

    Health related quality of life

    Measured: 3 weeks

  19. PROMIS

    Health related quality of life

    Measured: 3 months

  20. PROMIS

    Health related quality of life

    Measured: 6 months

  21. PROMIS

    Health related quality of life

    Measured: 12 months

  22. 10 meter walk test

    Walking speed, time in m/sec

    Measured: Weekly through stay, average of 3 weeks

  23. 10 meter walk test

    Walking speed, time in m/sec

    Measured: 3 weeks

  24. 10 meter walk test

    Walking speed, time in m/sec

    Measured: 3 months

  25. 10 meter walk test

    Walking speed, time in m/sec

    Measured: 6 months

  26. 6 minute walk test

    Walking distance in meters

    Measured: Weekly through stay, average of 3 weeks

  27. 6 minute walk test

    Walking distance in meters

    Measured: 3 weeks

  28. 6 minute walk test

    Walking distance in meters

    Measured: 3 months

  29. 6 minute walk test

    Walking distance in meters

    Measured: 6 months

  30. Berg balance scale

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

    Measured: Weekly through stay, average of 3 weeks

  31. Berg balance scale

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

    Measured: 3 weeks

  32. Berg balance scale

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

    Measured: 3 months

  33. Berg balance scale

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

    Measured: 6 months

  34. MiniBESTest

    Balance measured on a scale 0-28, higher scores indicate a better outcome

    Measured: Weekly through stay, average of 3 weeks

  35. MiniBESTest

    Balance measured on a scale 0-28, higher scores indicate a better outcome

    Measured: 3 weeks

  36. MiniBESTest

    Balance measured on a scale 0-28, higher scores indicate a better outcome

    Measured: 3 months

  37. MiniBESTest

    Balance measured on a scale 0-28, higher scores indicate a better outcome

    Measured: 6 months

  38. MiniBESTest

    Balance measured on a scale 0-28, higher scores indicate a better outcome

    Measured: 12 months

  39. Patient Satisfaction with treatment

    6 questions on satisfaction with treatment, Likert scale,

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2021
  2. Study start20 Jun 2021
  3. Primary completion4 Sep 2023
  4. Study completion4 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04870619
Sponsor's protocol ID
216346
Status last verified
Nov 2023
First submitted
23 Apr 2021
Last updated
3 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31884902

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Oslo University Hospital at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

10 meter walk test (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04870619, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.

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FIRST-Oslo Long-term Follow-up (NCT04870619) | AzTrials