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CompletedNCT03284580Updated Sep 15, 2017

Effectiveness of a Home-based Ergonomic Intervention Program in Caregivers of Chronic Post-stroke Patients

An interventional study of Ergonomic intervention and Postural plus kinesiotherapy intervention program in Stroke and Quality of Life, sponsored by Universidad de Granada. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-15.

Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The objective of the present study is to evaluate the effectiveness of two home-based ergonomic intervention programs compared to a control group on the quality of life of caregivers of post-stroke patients

Read the detailed description

Stroke is a neurological pathology that can cause functional problems and an impairment to perform activities of daily living at home.

For this reason, these patients need the support of a caregiver. Caregivers of post-stroke patients often have also problems with their quality of life because of the care that they must provide. These problems appear mainly during the support tasks in the activities performed at the patient's home.

The objective of the present study is to evaluate the effectiveness of two home-based ergonomic intervention programs compared to a control group on the quality of life of caregivers of post-stroke patients

02

Conditions studied

  • Stroke
  • Quality of Life

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03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Being caregivers of post-stroke patients
  • Being over 18 years old

Exclusion criteria

Exclusion Criteria:

  • Being caregiver of patients with other neurological patients
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Ergonomic intervention group

    Ergonomic intervention program at home for caregivers

    Other: Ergonomic intervention

  • Experimental
    Postural + kinesiotherapy intervention group

    A postural + kinesiotherapy intervention program at home for caregivers

    Other: Postural plus kinesiotherapy intervention program

  • Other
    Control or conservative group

    A conservative intervention by general information for caregivers

    Other: Control or conservative intervention

Interventions

  • OtherErgonomic intervention

    An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.

  • OtherPostural plus kinesiotherapy intervention program

    An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.

    Also known as: A postural plus kinesiotherapy intervention program, including excercises for caregivers

  • OtherControl or conservative intervention

    A control or conservative intervention, including general information about stroke disease for the caregivers of these patients

05

What researchers measure

Primary outcomes

  1. Change from WhoQol-Bref at 8 weeks

    This test measures quality of life

    Time frame: Eight weeks

  2. Change from WhoQol-Bref at 16 weeks

    This test measures quality of life

    Time frame: Sixteen weeks

Secondary outcomes

  1. Change from ergonomic evaluation of the domestic environment at 8 weeks

    This measurement evaluates if domestic environment is ergonomic

    Time frame: Eight weeks

  2. Change from ergonomic evaluation of the domestic environment at 16 weeks

    This measurement evaluates if domestic environment is ergonomic

    Time frame: Sixteen weeks

06

Study locations

1 site
  • José Manuel Pérez Mármol
    Córdoba, 18007, Spain
07

References and documents

Publications

  • de Araujo Freitas Moreira KL, Abalos-Medina GM, Villaverde-Gutierrez C, Gomes de Lucena NM, Belmont Correia de Oliveira A, Perez-Marmol JM. Effectiveness of two home ergonomic programs in reducing pain and enhancing quality of life in informal caregivers of post-stroke patients: A pilot randomized controlled clinical trial. Disabil Health J. 2018 Jul;11(3):471-477. doi: 10.1016/j.dhjo.2018.01.003. Epub 2018 Feb 13. PubMed 29452985 ↗
08

Registry details

Key details

Study ID
NCT03284580
Lead sponsor
Universidad de Granada
Responsible party
José Manuel Pérez Mármol (Principal Investigator, Universidad de Granada) — Principal investigator
First posted
Sep 15, 2017
Start date
Jan 8, 2017
Primary completion
Aug 9, 2017
Completion
Aug 20, 2017
Last update
Sep 15, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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