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Effects of Two Home Ergonomics Programmes in Post-stroke Patients

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ClinicalTrials.gov Identifier: NCT03665220
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
José Manuel Pérez Mármol, Universidad de Granada

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.

Condition or disease Intervention/treatment Phase
Stroke Quality of Life Other: Ergonomic adjustments Other: Kinesiotherapy plus ergonomic adjustments Other: Healthcare education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Two Home Ergonomics Programmes on Post-stroke Patients' Quality of Life and Functional Capacity: a Randomised Controlled Clinical Trial
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : April 15, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ergonomics

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.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Change from the Older Americans Resources and Services (OARS) scale at 12 weeks [ Time Frame: Twelve 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.

  2. Change from the Older Americans Resources and Services (OARS) scale at 24 weeks [ Time Frame: Twenty four 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665220


Locations
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Spain
José Manuel Pérez Mármol
Granada, Spain, 18007
Sponsors and Collaborators
Universidad de Granada
Investigators
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Principal Investigator: José Manuel Pérez Mármol Department of Physiotherapy. Faculty of Health Sciences, University of Granada

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Responsible Party: José Manuel Pérez Mármol, Principal Investigator, Universidad de Granada
ClinicalTrials.gov Identifier: NCT03665220     History of Changes
Other Study ID Numbers: Rehab in post-stroke patients
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

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

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases