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

NCT02118480 | Completed DMC

• 1 other identifier: NSMC-001-UD
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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).

Conditions

PARKINSON DISEASE (Disorder)

Keywords

Parkinson disease, cognitive rehabilitation, REHACOP

Outcome Measures

Primary Outcomes (5)

• Change in processing speed after receiving cognitive rehabilitation treatment

  3 months

• Change in verbal memory performance after receiving cognitive remediation treatment

  3 months

• Change in visual memory after receiving cognitive remediation treatment

  3 months

• Change in executive functioning after receiving cognitive remediation treatment

  3 months

• Change in theory of mind after receiving cognitive remediation treatment

  3 months

Secondary Outcomes (3)

• Change in apathy after receiving cognitive remediation treatment

  3 months

• Change in functional disability after receiving cognitive remediation treatment

  3 months

• Change in depression after receiving cognitive remediation treatment

  3 months

Study Arms (2)

cognitive remediation program: REHACOP

EXPERIMENTAL

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

Occupational Therapy

ACTIVE COMPARATOR

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

Interventions

cognitive remediation program: REHACOP OTHER

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.

cognitive remediation program: REHACOP

Occupational Therapy OTHER

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.

Occupational Therapy

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Deusto: lead

Study Sites (1)

University of Deusto

Bilbao, Biskai, 48007, Spain

Location

Related Publications (1)

• Pena J, Ibarretxe-Bilbao N, Garcia-Gorostiaga I, Gomez-Beldarrain MA, Diez-Cirarda M, Ojeda N. Improving functional disability and cognition in Parkinson disease: randomized controlled trial. Neurology. 2014 Dec 2;83(23):2167-74. doi: 10.1212/WNL.0000000000001043. Epub 2014 Oct 31.

  PMID: 25361785 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Naroa Ibarretxe-Bilbao, Doctor

  University of Deusto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 21, 2014
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 24, 2018

Record last verified: 2018-01

Locations

ES (1)