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Effects of Two Home Ergonomics Programmes in Post-stroke Patients

Primary Purpose

Stroke, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ergonomic adjustments
Kinesiotherapy plus ergonomic adjustments
Healthcare education
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • José Manuel Pérez Mármol

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Ergonomic adjustment group

Kinesiotherapy + ergonomics group

Healthcare education

Arm Description

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.

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).

A conservative intervention program for post-stroke patients

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 6, 2018
Last Updated
July 5, 2021
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT03665220
Brief Title
Effects of Two Home Ergonomics Programmes in Post-stroke Patients
Official Title
Effects of Two Home Ergonomics Programmes on Post-stroke Patients' Quality of Life and Functional Capacity: a Randomised Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
May 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ergonomic adjustment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Kinesiotherapy + ergonomics group
Arm Type
Experimental
Arm Description
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).
Arm Title
Healthcare education
Arm Type
Active Comparator
Arm Description
A conservative intervention program for post-stroke patients
Intervention Type
Other
Intervention Name(s)
Ergonomic adjustments
Intervention Description
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 Type
Other
Intervention Name(s)
Kinesiotherapy plus ergonomic adjustments
Intervention Description
This group received, in addition to the ergonomic adjustments described above, sessions of postural orientation and kinesiotherapy (therapeutic exercises).
Intervention Type
Other
Intervention Name(s)
Healthcare education
Intervention Description
This group received health education information, based on an illustrated manual with advice for patients with chronic stroke.
Primary Outcome Measure Information:
Title
Change from the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 12 weeks
Description
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.
Time Frame
Twelve weeks
Title
Change from the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 24 weeks
Description
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.
Time Frame
Twenty four weeks
Secondary Outcome Measure Information:
Title
Change from the Older Americans Resources and Services (OARS) scale at 12 weeks
Description
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.
Time Frame
Twelve weeks
Title
Change from the Older Americans Resources and Services (OARS) scale at 24 weeks
Description
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.
Time Frame
Twenty four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Manuel Pérez Mármol
Organizational Affiliation
Department of Physiotherapy. Faculty of Health Sciences, University of Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
José Manuel Pérez Mármol
City
Granada
ZIP/Postal Code
18007
Country
Spain

12. IPD Sharing Statement

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Effects of Two Home Ergonomics Programmes in Post-stroke Patients

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