More Steps Towards an Active Life After Stroke - ActForStroke
ActForStroke
2 other identifiers
interventional
50
1 country
10
Brief Summary
The main goal of this quasi-experimental study is to prevent the negative consequences of mobility impairments after stroke. These include recurrent strokes, general deconditioning, and overweight on the physical side, and dependency, isolation, caregiver strain, and reduced quality of life from a psycho-social perspective. ActForStroke, a combination of high-intensity gait training and subsequent remote coaching and activity monitoring, will contribute to more steps, higher activity levels and increased participation. ActForStroke requires minimal extra resources and can easily be implemented within existing staffing levels. The investigators want to examine if patients who participate in the ActForStroke intervention are more active one year after stroke. Patients with stroke will either participate in a combined intervention of high-intensity gait training and subsequent coaching to facilitate physical and social activity or receive standard care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2025
Typical duration for not_applicable
10 active sites
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
November 18, 2024
CompletedFirst Posted
Study publicly available on registry
December 4, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
December 4, 2024
November 1, 2024
1.6 years
November 18, 2024
December 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical activity
The main outcome measure will be the average number of non-sedentary minutes per day measured during 3 days of sensor measurements. The SENS motion® wearable sensor will be used to monitor physical activity during 3 days. The SENS motion® registers acceleration on x,y,z axes.
From baseline up to 12 months after stroke, 4 assessments will be conducted at inclusion to the study, 2 weeks after inclusion, 6 months and 12 months after stroke.
Secondary Outcomes (9)
10m walk test
Two assessments: At inclusion to the study, 2 weeks after inclusion.
Timed-up-and-go
Two assessments: At inclusion to the study, 2 weeks after inclusion.
6 minutes walk test
Two assessments: At inclusion to the study, 2 weeks after inclusion.
Sit-to-stand test
Two assessments: At inclusion to the study, 2 weeks after inclusion.
Five-level EQ5d (EQ5D) (there is no full name)
Four assessments up to 12 months after stroke: At inclusion, after two weeks, 6 months and 12 months after stroke.
- +4 more secondary outcomes
Study Arms (2)
ActForStroke
EXPERIMENTALA combination of high-intensity gait training and coaching to encourage physical and social activity.
Standard care
ACTIVE COMPARATORStandard care usually provided
Interventions
ActForStroke is a combination of 10 sessions high-intensity gait training and subsequent with up 7 coaching sessions until 1 year after stroke.
Eligibility Criteria
You may qualify if:
- ≥18 years
- stroke within the last 6 months
- able to give informed consent according to the neurorehabilitation team's evaluation and/or cognitive testing
- receiving rehabilitation for post-stroke functional impairments.
You may not qualify if:
- 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 (independent ambulator on all surfaces)
- uncontrolled cardiopulmonary, metabolic, infectious or psychiatric disorders
- any disorder that prevented walking \> 50 meters prior to injury
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Regional Hospital Hammel Neurorehabilitation Centrecollaborator
- University College Nordjyllandcollaborator
Study Sites (10)
Genoptræning Aalborg Municipality
Aalborg, Denmark, 9000, Denmark
Neuroenhed Nord Brønderslev
Brønderslev, Denmark, 9700, Denmark
Neurocentet København
Copenhagen, Denmark, 2100, Denmark
Hammel Neurocenter and University Research Clinic, Denmark
Hammel, Denmark, 8000, Denmark
Favrskov Municipality
Hammel, Denmark, 8450, Denmark
Jammerbugt Municipality Neuroteam
Jammerbugt, Denmark, 9460, Denmark
Skive Sundhedsafdeling
Skive, Denmark, 7800, Denmark
Svendborg Neurorehabilitation
Svendborg, Denmark, 5700, Denmark
Thisted Municipality
Thisted, Denmark, 7700, Denmark
Vejle Municipality
Vejle, Denmark, 7100, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Iris C. Brunner, Phd
Aarhus University, Hammel Neurocenter
- PRINCIPAL INVESTIGATOR
Gunhild M. Hansen, PhD
University College Nord, Aalborg, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2024
First Posted
December 4, 2024
Study Start
January 1, 2025
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
December 4, 2024
Record last verified: 2024-11