FIRST-Oslo Long-term Follow-up

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0514
    • Oslo University Hospital
  • Oslo, Norway
    • Oslo municipality - Enhanced Rehabilitation Aker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Sunnaas Rehabilitation Hospital; Indiana University School of Medicine; Norwegian Fund for Postgraduate Training in Physiotherapy; City of Oslo
• Investigators: Principal Investigator: Elisabeth Bø, PhD, Oslo Univeristy Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2021
• Primary Completion (Actual): September 4, 2023
• Study Completion (Actual): September 4, 2023

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: High Intensity Gait Training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 216346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No