Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
69 participants
INTERVENTIONAL
2017-06-15
2021-08-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Intensified Occupational Therapy on Basic Activities of Daily Living
NCT05638607
Stroke and Rehabilitation in North of Norway and Central Denmark
NCT03948906
Interdisciplinary Home Rehabilitation of Patients With Stroke. A Randomised Controlled Intervention Trial.
NCT00626353
MONitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke
NCT05793177
Quality of Life and Rehabilitation Pathway in Northern Norway and Denmark.
NCT02369055
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The aim of this study is to investigate the effect of a novel self-management intervention supporting older adults after stroke
Methods/Design: Randomized controlled observer-blind trial. More than sixty stroke survivors over 65 years will two weeks before leaving a rehabilitation hospital be randomized to either a group receiving conventional rehabilitation (control) or a novel self-management intervention addition to standard rehabilitation.
During a period of 6 months the patients will be offered additional 6-8 sessions of self-management intervention of 45-60 minutes duration by a physiotherapist or an occupational therapist.
Study outcome measurements: Stroke Self-efficacy questionnaire, Stroke Specific Quality of Life Scale and Impact on participation and Autonomy and activity by accelerometers will be evaluated at baseline, three and nine months post hospital treatment.
Patient, informal caregiver and therapist satisfaction will be with examined with questionnaires and interviews.
Discussion: Self-management interventions are promising tools for rehabilitation of self-efficacy, quality of life as well as participation and autonomy. The introduction of novel self management intervention in combination with traditional physical and occupational therapy may enhance recovery after stroke, quality of life and burden on relatives. Stroke 65+ trial will provide further evidence of self management strategies to clinicians, patients and health economists.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mentor
An independent centralized randomization database will provide allocation concealed to the involved clinicians and assessors. A stratified block randomization of severity of impairment will be performed within each rehabilitation hospital
Mentor
Traditional rehabilitation.
Traditional rehabilitation
An independent centralized randomization database will provide allocation concealed to the involved clinicians and assessors. A stratified block randomization of severity of impairment will be performed within each rehabilitation hospital
Mentor
Traditional rehabilitation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mentor
Traditional rehabilitation.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Central Jutland Regional Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hanne Pallesen
Physiotherapist, PhD. Head of Clinical Physiotherapy Research, at Hammel Neurorehabilitation Centre and University Research Clinic, Hammel, Denmark
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hanne Pallesen, Post Doc
Role: PRINCIPAL_INVESTIGATOR
Hammel Neurorehabilitation Centre and University Research Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Region Hospital Hammel Neurocentre
Hammel, Jutland, Denmark
Region Hospital Hammmel Neurorehabilitation
Hammel, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pallesen H, Pedersen SKS, Sorensen SL, Naess-Schmidt ET, Brunner I, Nielsen JF, Kjeldsen SS. "Stroke - 65 plus. Continued active life." A randomized controlled trial of a self-management neurorehabilitation intervention for elderly people after stroke. Disabil Rehabil. 2025 Jan;47(1):104-113. doi: 10.1080/09638288.2024.2338190. Epub 2024 Apr 8.
Pedersen SKS, Pallesen H. Stroke self-efficacy questionnaire - Denmark (SSEQ-DK): test-retest of the Danish version. Top Stroke Rehabil. 2023 Mar;30(2):193-202. doi: 10.1080/10749357.2021.2016097. Epub 2022 Jan 7.
Sorensen SL, Pedersen SKS, Pallesen H. Social psychological mechanisms and processes in a novel, health professional-led, self-management intervention for older stroke individuals: a synthesis and phenomenological study. BMC Health Serv Res. 2019 May 22;19(1):320. doi: 10.1186/s12913-019-4150-x.
Pallesen H, Naess-Schmidt ET, Kjeldsen SS, Pedersen SKS, Sorensen SL, Brunner I, Nielsen JF. "Stroke - 65 Plus. Continued Active Life": a study protocol for a randomized controlled cross-sectoral trial of the effect of a novel self-management intervention to support elderly people after stroke. Trials. 2018 Nov 19;19(1):639. doi: 10.1186/s13063-018-2961-4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JutlandRH54962
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.