FIRST-Oslo Long-term Follow-up

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04870619
• Other study ID #: 216346
• Status: Completed
• Start date: June 20, 2021
• Est. completion date: September 4, 2023

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. These data will determine if the observed gains from the high-intensity gait training are retained after discharge from inpatient rehabilitation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 4, 2023
• Est. primary completion date: September 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo municipality - Enhanced Rehabilitation Aker	Oslo
Norway	Oslo University Hospital	Oslo

Sponsors (5)

Lead Sponsor	Collaborator
Oslo University Hospital	City of Oslo, Indiana University School of Medicine, Norwegian Fund for Postgraduate Training in Physiotherapy, Sunnaas Rehabilitation Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10 meter walk test	Walking speed	12 months
Primary	6-minute walk test	Walking distance	12 months
Primary	Berg balance scale	Balance measured on a scale 0-56 points, higher scores mean a better outcome	12 months
Primary	Steps	Number of Steps	Daily through stay, average of 3 weeks
Primary	Intensity	Heart Rate during training	Each PT session trough stay, and average of 3 weeks
Secondary	Sit-to-stand x5	Functional strength, time to complete in sec	3 weeks
Secondary	Sit-to-stand x5	Functional strength, time to complete in sec	3 months
Secondary	Sit-to-stand x5	Functional strength, time to complete in sec	6 months
Secondary	Sit-to-stand x5	Functional strength, time to complete in sec	12 months
Secondary	Manual muscle testing	Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome	3 weeks
Secondary	Manual muscle testing	Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome	3 months
Secondary	Manual muscle testing	Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome	6 months
Secondary	Manual muscle testing	Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	EQ-5D-5L	Health related quality of life	3 weeks
Secondary	EQ-5D-5L	Health related quality of life	3 months
Secondary	EQ-5D-5L	Health related quality of life	6 months
Secondary	EQ-5D-5L	Health related quality of life	12 months
Secondary	PROMIS	Health related quality of life	3 weeks
Secondary	PROMIS	Health related quality of life	3 months
Secondary	PROMIS	Health related quality of life	6 months
Secondary	PROMIS	Health related quality of life	12 months
Secondary	10 meter walk test	Walking speed, time in m/sec	Weekly through stay, average of 3 weeks
Secondary	10 meter walk test	Walking speed, time in m/sec	3 weeks
Secondary	10 meter walk test	Walking speed, time in m/sec	3 months
Secondary	10 meter walk test	Walking speed, time in m/sec	6 months
Secondary	6 minute walk test	Walking distance in meters	Weekly through stay, average of 3 weeks
Secondary	6 minute walk test	Walking distance in meters	3 weeks
Secondary	6 minute walk test	Walking distance in meters	3 months
Secondary	6 minute walk test	Walking distance in meters	6 months
Secondary	Berg balance scale	Balance measured on a scale 0-56 points, higher scores indicate a better outcome	Weekly through stay, average of 3 weeks
Secondary	Berg balance scale	Balance measured on a scale 0-56 points, higher scores indicate a better outcome	3 weeks
Secondary	Berg balance scale	Balance measured on a scale 0-56 points, higher scores indicate a better outcome	3 months
Secondary	Berg balance scale	Balance measured on a scale 0-56 points, higher scores indicate a better outcome	6 months
Secondary	MiniBESTest	Balance measured on a scale 0-28, higher scores indicate a better outcome	Weekly through stay, average of 3 weeks
Secondary	MiniBESTest	Balance measured on a scale 0-28, higher scores indicate a better outcome	3 weeks
Secondary	MiniBESTest	Balance measured on a scale 0-28, higher scores indicate a better outcome	3 months
Secondary	MiniBESTest	Balance measured on a scale 0-28, higher scores indicate a better outcome	6 months
Secondary	MiniBESTest	Balance measured on a scale 0-28, higher scores indicate a better outcome	12 months
Secondary	Patient Satisfaction with treatment	6 questions on satisfaction with treatment, Likert scale,	12 months