Effects of Two Home Ergonomics Programmes on Post-stroke Patients' Quality of Life and Functional Capacity: a Randomised Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Granada
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change from the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 12 weeks
Study Overview
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.
Detailed Description
For post-stroke patients, rehabilitation must address different aspects. When the resulting condition has become established, treatment should take the form of a mixed intervention model, incorporating preventive, rehabilitational and compensatory or adaptive approaches, aimed at enhancing the patient's performance within the environment. Physiotherapy and occupational therapy are key disciplines in the composition of multi- and inter-disciplinary teams for the care of stroke patients. In this clinical trial we evaluate the effectiveness of two programmes of ergonomic intervention in the home, with respect to levels of functionality (performance of activities of daily living) and the quality of life of post-stroke patients, by reference to a control group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •stroke diagnosed 6-24 months previously
- •aged over 18 years
- •ability to speak and understand Portuguese.
Exclusion Criteria
- •severe cognitive deficit
- •severe aphasia
- •other associated neurological disease
- •musculoskeletal pathology
- •drug or alcohol abuse.
Arms & Interventions
Ergonomic adjustment group
Ergonomic 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.
Intervention: Ergonomic adjustments (Other)
Kinesiotherapy + ergonomics group
A 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).
Intervention: Kinesiotherapy plus ergonomic adjustments (Other)
Healthcare education
A conservative intervention program for post-stroke patients
Intervention: Healthcare education (Other)
Outcomes
Primary Outcomes
Change from the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 12 weeks
Time Frame: Twelve 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.
Change from the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 24 weeks
Time Frame: Twenty four 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.
Secondary Outcomes
- 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)
Investigators
José Manuel Pérez Mármol
Principal Investigator
Universidad de Granada