NCT04870619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 20, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2023

Completed
Last Updated

November 3, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

April 23, 2021

Last Update Submit

November 1, 2023

Conditions

Stroke

Keywords

High Intensity Gait Training

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (39)

  • Sit-to-stand x5

    3 weeks

  • Sit-to-stand x5

    3 months

  • Sit-to-stand x5

    6 months

  • Sit-to-stand x5

    12 months

  • Manual muscle testing

    3 weeks

  • +34 more secondary outcomes

Interventions

High Intensity Gait TrainingOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oslo University Hospital

Oslo, 0514, Norway

Location

Oslo municipality - Enhanced Rehabilitation Aker

Oslo, Norway

Location

Related 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.119.027450. Epub 2019 Dec 30.

    PMID: 31884902RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Elisabeth Bø, PhD

    Oslo Univeristy Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist PhD

Study Record Dates

First Submitted

April 23, 2021

First Posted

May 3, 2021

Study Start

June 20, 2021

Primary Completion

September 4, 2023

Study Completion

September 4, 2023

Last Updated

November 3, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)