FIRST-Oslo Long-term Follow-up

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Other: High Intensity Gait Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 meter walk test | Walking speed | 12 months | 
| 6-minute walk test | Walking distance | 12 months | 
| Berg balance scale | Balance measured on a scale 0-56 points, higher scores mean a better outcome | 12 months | 
| Steps | Number of Steps | Daily through stay, average of 3 weeks | 
| Intensity | Heart Rate during training | Each PT session trough stay, and average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sit-to-stand x5 | Functional strength, time to complete in sec | 3 weeks | 
| Sit-to-stand x5 | Functional strength, time to complete in sec | 3 months | 
| Sit-to-stand x5 | Functional strength, time to complete in sec | 6 months | 
| Sit-to-stand x5 | Functional strength, time to complete in sec | 12 months | 
| Manual muscle testing | Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome | 3 weeks | 
| Manual muscle testing | Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome | 3 months | 
| Manual muscle testing | Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome | 6 months | 
| Manual muscle testing | Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome | 12 months | 
| 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 | Weekly during inpatient stay, in average 3 weeks | 
| 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 | 3 weeks | 
| 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 | 3 months | 
| 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 | 6 months | 
| 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 | 12 months | 
| EQ-5D-5L | Health related quality of life | 3 weeks | 
| EQ-5D-5L | Health related quality of life | 3 months | 
| EQ-5D-5L | Health related quality of life | 6 months | 
| EQ-5D-5L | Health related quality of life | 12 months | 
| PROMIS | Health related quality of life | 3 weeks | 
| PROMIS | Health related quality of life | 3 months | 
| PROMIS | Health related quality of life | 6 months | 
| PROMIS | Health related quality of life | 12 months | 
| 10 meter walk test | Walking speed, time in m/sec | Weekly through stay, average of 3 weeks | 
| 10 meter walk test | Walking speed, time in m/sec | 3 weeks | 
| 10 meter walk test | Walking speed, time in m/sec | 3 months | 
| 10 meter walk test | Walking speed, time in m/sec | 6 months | 
| 6 minute walk test | Walking distance in meters | Weekly through stay, average of 3 weeks | 
| 6 minute walk test | Walking distance in meters | 3 weeks | 
| 6 minute walk test | Walking distance in meters | 3 months | 
| 6 minute walk test | Walking distance in meters | 6 months | 
| Berg balance scale | Balance measured on a scale 0-56 points, higher scores indicate a better outcome | Weekly through stay, average of 3 weeks | 
| Berg balance scale | Balance measured on a scale 0-56 points, higher scores indicate a better outcome | 3 weeks | 
| Berg balance scale | Balance measured on a scale 0-56 points, higher scores indicate a better outcome | 3 months | 
| Berg balance scale | Balance measured on a scale 0-56 points, higher scores indicate a better outcome | 6 months | 
| MiniBESTest | Balance measured on a scale 0-28, higher scores indicate a better outcome | Weekly through stay, average of 3 weeks | 
| MiniBESTest | Balance measured on a scale 0-28, higher scores indicate a better outcome | 3 weeks | 
| MiniBESTest | Balance measured on a scale 0-28, higher scores indicate a better outcome | 3 months | 
| MiniBESTest | Balance measured on a scale 0-28, higher scores indicate a better outcome | 6 months | 
| MiniBESTest | Balance measured on a scale 0-28, higher scores indicate a better outcome | 12 months | 
| Patient Satisfaction with treatment | 6 questions on satisfaction with treatment, Likert scale, | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Intensity Gait Training