Skip to main content
OpenTrials
Completed

NCT Number: NCT04870619

FIRST-Oslo Long-term Follow-up

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital, Oslo, Norway

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Gait Training

Other

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.

Primary outcomes

  1. 10 meter walk test

    Time frame: 12 months

    Walking speed

  2. 6-minute walk test

    Time frame: 12 months

    Walking distance

  3. Berg balance scale

    Time frame: 12 months

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

  4. Steps

    Time frame: Daily through stay, average of 3 weeks

    Number of Steps

  5. Intensity

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

    Heart Rate during training

Secondary outcomes

  1. Sit-to-stand x5

    Time frame: 3 weeks

    Functional strength, time to complete in sec

  2. Sit-to-stand x5

    Time frame: 3 months

    Functional strength, time to complete in sec

  3. Sit-to-stand x5

    Time frame: 6 months

    Functional strength, time to complete in sec

  4. Sit-to-stand x5

    Time frame: 12 months

    Functional strength, time to complete in sec

  5. Manual muscle testing

    Time frame: 3 weeks

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

  6. Manual muscle testing

    Time frame: 3 months

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

  7. Manual muscle testing

    Time frame: 6 months

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

  8. Manual muscle testing

    Time frame: 12 months

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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. EQ-5D-5L

    Time frame: 3 weeks

    Health related quality of life

  15. EQ-5D-5L

    Time frame: 3 months

    Health related quality of life

  16. EQ-5D-5L

    Time frame: 6 months

    Health related quality of life

  17. EQ-5D-5L

    Time frame: 12 months

    Health related quality of life

  18. PROMIS

    Time frame: 3 weeks

    Health related quality of life

  19. PROMIS

    Time frame: 3 months

    Health related quality of life

  20. PROMIS

    Time frame: 6 months

    Health related quality of life

  21. PROMIS

    Time frame: 12 months

    Health related quality of life

  22. 10 meter walk test

    Time frame: Weekly through stay, average of 3 weeks

    Walking speed, time in m/sec

  23. 10 meter walk test

    Time frame: 3 weeks

    Walking speed, time in m/sec

  24. 10 meter walk test

    Time frame: 3 months

    Walking speed, time in m/sec

  25. 10 meter walk test

    Time frame: 6 months

    Walking speed, time in m/sec

  26. 6 minute walk test

    Time frame: Weekly through stay, average of 3 weeks

    Walking distance in meters

  27. 6 minute walk test

    Time frame: 3 weeks

    Walking distance in meters

  28. 6 minute walk test

    Time frame: 3 months

    Walking distance in meters

  29. 6 minute walk test

    Time frame: 6 months

    Walking distance in meters

  30. 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

  31. Berg balance scale

    Time frame: 3 weeks

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

  32. Berg balance scale

    Time frame: 3 months

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

  33. Berg balance scale

    Time frame: 6 months

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

  34. MiniBESTest

    Time frame: Weekly through stay, average of 3 weeks

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

  35. MiniBESTest

    Time frame: 3 weeks

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

  36. MiniBESTest

    Time frame: 3 months

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

  37. MiniBESTest

    Time frame: 6 months

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

  38. MiniBESTest

    Time frame: 12 months

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

  39. Patient Satisfaction with treatment

    Time frame: 12 months

    6 questions on satisfaction with treatment, Likert scale,

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • City of Oslo
  • Indiana University
  • Norwegian Fund for Postgraduate Training in Physiotherapy
  • Sunnaas Rehabilitation Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 3, 2021
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.