FIRST-Oslo Long-term Follow-up

Completed

• Conditions: Stroke

• Registration Number: NCT04870619
• Lead Sponsor: Oslo University Hospital

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.

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 Timeline

• Study First Submitted: 2021-04-23
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-05-03
• Study Start: 2021-06-20
• Primary Completion: 2023-09-04
• Study Completion: 2023-09-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Sit-to-stand x5	12 months	Functional strength, time to complete in sec
Action-Research-Arm-Test (ARAT)	12 months	Evaluation tool for motot function in the upper extremity after neurological injuries. Ordinal scale 0-57, higher score indicate better outcome
10 meter walk test	6 months	Walking speed, time in m/sec
EQ-5D-5L	12 months	Health related quality of life
Manual muscle testing	12 months	Strength of lower extremities, ordinal scale 0-5, higher score indicate better outcome
MiniBESTest	12 months	Balance measured on a scale 0-28, higher scores indicate a better outcome
PROMIS	12 months	Health related quality of life
6 minute walk test	6 months	Walking distance in meters
Berg balance scale	6 months	Balance measured on a scale 0-56 points, higher scores indicate a better outcome
Patient Satisfaction with treatment	12 months	6 questions on satisfaction with treatment, Likert scale,

Trial Locations

Locations (2)

Oslo municipality - Enhanced Rehabilitation Aker; 🇳🇴 Oslo, Norway

Oslo University Hospital; 🇳🇴 Oslo, Norway