Effects of Two Home Ergonomics Programmes in Post-stroke Patients
1 other identifier
interventional
34
1 country
1
Brief Summary
The main objective of the clinical trial is to evaluate the effectiveness of two home ergonomics programmes, by reference to a control group, on functional capacity and quality of life in post-stroke patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started May 2017
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 6, 2018
CompletedFirst Posted
Study publicly available on registry
September 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2020
CompletedJuly 7, 2021
July 1, 2021
3 years
September 6, 2018
July 5, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Change from the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 12 weeks
The quality of life is assessed on the WHOQoL-Bref scale, on a range from 0 to 100 points, where 100 is the highest level of quality of life. For each domain, with the exception of the first two questions, the quality of life was considered to be impaired when a score \<70 points was assigned.
Twelve weeks
Change from the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 24 weeks
The quality of life is assessed on the WHOQoL-Bref scale, on a range from 0 to 100 points, where 100 is the highest level of quality of life. For each domain, with the exception of the first two questions, the quality of life was considered to be impaired when a score \<70 points was assigned.
Twenty four weeks
Secondary Outcomes (2)
Change from the Older Americans Resources and Services (OARS) scale at 12 weeks
Twelve weeks
Change from the Older Americans Resources and Services (OARS) scale at 24 weeks
Twenty four weeks
Study Arms (3)
Ergonomic adjustment group
EXPERIMENTALErgonomic intervention program at home for post-stroke patients. The ergonomic adjustments made were based on a prior assessment of the patient's needs in this respect, using a purpose-made home inspection form.
Kinesiotherapy + ergonomics group
EXPERIMENTALA Kinesiotherapy plus ergonomic adjustments program for post-stroke patients. This group received, in addition to the ergonomic adjustments described above, sessions of postural orientation and kinesiotherapy (therapeutic exercises).
Healthcare education
ACTIVE COMPARATORA conservative intervention program for post-stroke patients
Interventions
The ergonomic adjustments made were based on a prior assessment of the patient's needs in this respect, using a purpose-made home inspection form .
This group received, in addition to the ergonomic adjustments described above, sessions of postural orientation and kinesiotherapy (therapeutic exercises).
This group received health education information, based on an illustrated manual with advice for patients with chronic stroke.
Eligibility Criteria
You may qualify if:
- stroke diagnosed 6-24 months previously
- aged over 18 years
- ability to speak and understand Portuguese.
You may not qualify if:
- severe cognitive deficit
- severe aphasia
- other associated neurological disease
- musculoskeletal pathology
- drug or alcohol abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
José Manuel Pérez Mármol
Granada, 18007, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José Manuel Pérez Mármol
Department of Physiotherapy. Faculty of Health Sciences, University of Granada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 6, 2018
First Posted
September 11, 2018
Study Start
May 1, 2017
Primary Completion
May 15, 2020
Study Completion
May 15, 2020
Last Updated
July 7, 2021
Record last verified: 2021-07