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FIRST-Oslo Long-term Follow-up

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ClinicalTrials.gov Identifier: NCT04870619
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : September 9, 2021
Sponsor:
Collaborators:
Indiana University School of Medicine
Norwegian Fund for Postgraduate Training in Physiotherapy
City of Oslo
Sunnaas Rehabilitation Hospital
Information provided by (Responsible Party):
Elisabeth Bø, Oslo University Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Stroke Other: High Intensity Gait Training

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 Design
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Study Type : Observational
Estimated Enrollment : 325 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FOCUSED INTENSIVE REPETITIVE STEP TRAINING - Long-term Follow-up of High Intensity Stepping Training After Stroke in Oslo (FIRST-Oslo - Long-term)
Actual Study Start Date : June 20, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023
Groups and Cohorts
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Intervention Details:
  • Other: High Intensity Gait Training
    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.

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04870619


Contacts
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Contact: Elisabeth Bø, PhD 04793066490 elisbo@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0514
Contact: Elisabeth Bø    93066490    elisabeth.bo@hf.hio.no   
Oslo municipality - Enhanced Rehabilitation Aker Recruiting
Oslo, Norway
Contact: Magnus Hågå, BSc         
Contact: Joakim Halvorsen, MSc         
Sponsors and Collaborators
Oslo University Hospital
Indiana University School of Medicine
Norwegian Fund for Postgraduate Training in Physiotherapy
City of Oslo
Sunnaas Rehabilitation Hospital
Investigators
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Principal Investigator: Elisabeth Bø, PhD Oslo Univeristy Hospital
More Information
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Publications of Results:

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Responsible Party: Elisabeth Bø, Physiotherapist PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04870619    
Other Study ID Numbers: 216346
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elisabeth Bø, Oslo University Hospital:
High Intensity Gait Training
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases