Effects of Two Home Ergonomics Programmes in Post-stroke Patients

Stroke Clinical Trial

Official title:

Effects of Two Home Ergonomics Programmes on Post-stroke Patients' Quality of Life and Functional Capacity: a Randomised Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665220
• Other study ID #: Rehab in post-stroke patients
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: May 15, 2020

Study information

• Verified date: July 2021
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life
• Stroke

Intervention

Other:
• Ergonomic adjustments
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 plus ergonomic adjustments
This group received, in addition to the ergonomic adjustments described above, sessions of postural orientation and kinesiotherapy (therapeutic exercises).
• Healthcare education
This group received health education information, based on an illustrated manual with advice for patients with chronic stroke.

Locations

Country	Name	City	State
Spain	José Manuel Pérez Mármol	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change from the Older Americans Resources and Services (OARS) scale at 12 weeks	Functional capacity is measured using the Older Americans Resources and Services (OARS) scale, which consists of two parts. The Brazilian-language version of this scale allows each part to be used independently. Each item is scored according to a Likert scale, ranging from 0 to 2 points, where 0 indicates a total level of dependence for the performance of ADL, 1 point corresponds to partial independence, and 2 points represents a satisfactory level of independence. The scale consists of 15 items that evaluate activities such as using the telephone, transport, shopping, preparing and consuming food, cleaning and housework, administering medicines, financial affairs, dressing and undressing, personal hygiene and grooming, functional mobility, getting into and out of bed, bathing and mobility in the bathroom.	Twelve weeks
Secondary	Change from the Older Americans Resources and Services (OARS) scale at 24 weeks	Functional capacity is measured using the Older Americans Resources and Services (OARS) scale, which consists of two parts. The Brazilian-language version of this scale allows each part to be used independently. Each item is scored according to a Likert scale, ranging from 0 to 2 points, where 0 indicates a total level of dependence for the performance of ADL, 1 point corresponds to partial independence, and 2 points represents a satisfactory level of independence. The scale consists of 15 items that evaluate activities such as using the telephone, transport, shopping, preparing and consuming food, cleaning and housework, administering medicines, financial affairs, dressing and undressing, personal hygiene and grooming, functional mobility, getting into and out of bed, bathing and mobility in the bathroom.	Twenty four weeks