Effects of Two Home Ergonomics Programmes in Post-stroke Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Quality of Life
• Intervention / Treatment: Other: Ergonomic adjustments; Other: Kinesiotherapy plus ergonomic adjustments; Other: Healthcare education

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18007
    • José Manuel Pérez Mármol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 .
Experimental: 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).	Other: Kinesiotherapy plus ergonomic adjustments; This group received, in addition to the ergonomic adjustments described above, sessions of postural orientation and kinesiotherapy (therapeutic exercises).
Active Comparator: Healthcare education; A conservative intervention program for post-stroke patients	Other: Healthcare education; This group received health education information, based on an illustrated manual with advice for patients with chronic stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: José Manuel Pérez Mármol, Department of Physiotherapy. Faculty of Health Sciences, University of Granada

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): May 15, 2020
• Study Completion (Actual): May 15, 2020

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 5, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Rehab in post-stroke patients

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No