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Improving Functional Disability and Cognition in Parkinson Disease: Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02118480
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
University of Deusto

Brief Summary:

The study design was a parallel-group randomized trial with equal randomization. Recruitment and enrollment were conducted between June 2012 and January 2013. At base-line, clinical, cognitive and functional data was collected. Afterwards, the participants were randomly allocated to either the REHACOP group or the Control group. During 3 months the intervention with REHACOP program took place and at follow-up patients were again re-evaluated to evaluate the changes in clinical, cognitive and functional measures. Post-treatment assessment (finished by June 2013) was performed within the first week after completing the intervention.Optional enrollment in pre- post neuroimaging will also allow us to look at changes in the brain. Finally, longitudinal follow-up at 18 months with neuropsychological and neuroimaging assessements was also performed.

Objective: To examine the efficacy of an integrative cognitive training program (REHACOP) to improve cognition, clinical symptoms and functional disability of patients with Parkinson disease (PD).


Condition or disease Intervention/treatment Phase
PARKINSON DISEASE (Disorder) Other: cognitive remediation program: REHACOP Other: Occupational Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Functional Disability and Cognition in Parkinson Disease: Randomized Controlled Trial
Study Start Date : June 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: cognitive remediation program: REHACOP
Cognitive rehabilitation program (REHACOP) including intervention in: attention, memory, processing speed, language, executive functioning and social cognition during 3 months, 3 times per week
Other: cognitive remediation program: REHACOP
Specifically, REHACOP group remediation with PD patients consisted of: Attention unit (4 weeks) training sustained, selective, alternant and divided attention; Memory unit (3 weeks) focusing on visual and verbal learning, recall and recognizing memory; Language unit (3 weeks) including grammar, syntax, vocabulary, verbal fluency, verbal comprehension, abstract language; Executive functions unit (2 weeks) training cognitive planning, proverbs, analogies; and Social cognition unit (1 week) exercising theory of mind, social reasoning and moral dilemmas.

Active Comparator: Occupational Therapy
The activities included drawing, reading the daily news and constructing using different materials (such as paper or wood) during 3 months, 3 times per week.
Other: Occupational Therapy
The activities included drawing, reading the daily news and constructing using different materials (such as paper or wood). These activities were accomplished in a group format and with the same frequency as the implementation of REHACOP in the experimental group.




Primary Outcome Measures :
  1. Change in processing speed after receiving cognitive rehabilitation treatment [ Time Frame: 3 months ]
  2. Change in verbal memory performance after receiving cognitive remediation treatment [ Time Frame: 3 months ]
  3. Change in visual memory after receiving cognitive remediation treatment [ Time Frame: 3 months ]
  4. Change in executive functioning after receiving cognitive remediation treatment [ Time Frame: 3 months ]
  5. Change in theory of mind after receiving cognitive remediation treatment [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Change in apathy after receiving cognitive remediation treatment [ Time Frame: 3 months ]
  2. Change in functional disability after receiving cognitive remediation treatment [ Time Frame: 3 months ]
  3. Change in depression after receiving cognitive remediation treatment [ Time Frame: 3 months ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of PD based on the United Kingdom PD Society Brain Bank (PDSBB) diagnostic criteria
  • age 45-75 years
  • either male or female
  • Hoehn and Yahr disease stage 1-3 as evaluated by the neurologist

Exclusion Criteria:

  • the presence of dementia as defined by the (DSM-IV-TR) Diagnostic and statistical manual of mental disorders IV Test Revised and the Movement Disorders Society specific clinical criteria for PD-dementia
  • the presence of other neurological illness or injury (Traumatic Brain Injury, Multiple Sclerosis)
  • unstable psychiatric disorders such as schizophrenia or major depression
  • the presence of visual hallucinations as assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q)

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): NCT02118480


Locations
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Spain
University of Deusto
Bilbao, Biskai, Spain, 48007
Sponsors and Collaborators
University of Deusto
Investigators
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Principal Investigator: Naroa Ibarretxe-Bilbao, Doctor University of Deusto
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Deusto
ClinicalTrials.gov Identifier: NCT02118480    
Other Study ID Numbers: NSMC-001-UD
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Keywords provided by University of Deusto:
Parkinson disease, cognitive rehabilitation, REHACOP
Additional relevant MeSH terms:
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Parkinson Disease
Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathologic Processes