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Cognitive Rehabilitation in Patients With Spina Bifida

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Sunnaas Rehabilitation Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Oslo
New York University School of Medicine
The Rusk Institute of Rehabilitation Medicine
Rotman Research Institute at Baycrest
University of Toronto
Information provided by:
Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01302314
First received: February 23, 2011
Last updated: March 1, 2011
Last verified: March 2011
History of Changes
  Purpose

This study will examine the effects of a theoretically grounded and manualized cognitive rehabilitation program on patients with Spina Bifida (SB). SB is often associated with deficit in higher order control over cognition, emotion and behaviour; which is typically referred to as executive functions. The present study will examine the efficacy of Goal Management Training (GMT) in patients with SB that experience executive difficulties. It is expected that GMT will have a favourable effect on cognitive executive functioning, psychological and health related factors.


Condition Intervention
Executive Dysfunction
Cognitive Deficits
Spina Bifida
 Behavioral: Goal management training (GMT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation in Patients With Spina Bifida: Effects on Executive Functions, Psychological and Health Related Factors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunnaas Rehabilitation Hospital:

Primary Outcome Measures:
  • Self and informant report of cognitive difficulties [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Behavior Rating Inventory for Executive Functions (BRIEF-A; Gioia et al., 2000).

  • Self and informant report of cognitive difficulties [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    The Dysexecutive Questionnaire (DEX; Burgess, Alderman, Emslie, Evans & Wilson, 1996).

  • self report of cognitive failures [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    Cognitive Failures Questionnaire (Broadbent, Cooper, FitzGerald, & Parkes, 1982).

  • self report of psychological problems [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    Symptom Checklist 25 (SCL-25; Derogatis, 1994).

  • self report of quality of life [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    SF36 (Ware & Sherbourne, 1992).

  • Self report of coping strategies [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    General Coping Questionnaire (GCQ-30; Joseph, Williams & Yule, 1992a).


Secondary Outcome Measures:
  • Cognitive functions measured by neuropsychological tests [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Tower from Delis- Kaplan Executive Function System (D-KEFS; Delis, Kaplan & Kramer, 2001).

  • Cognitive functions measured by neuropsychological tests [ Time Frame: baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    TMT from Delis- Kaplan Executive Function System (D-KEFS; Delis, Kaplan & Kramer, 2001).

  • Cognitive functions measured by neuropsychological tests [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    Stroop from Delis- Kaplan Executive Function System (D-KEFS; Delis, Kaplan & Kramer, 2001).

  • Cognitive functions measured by neuropsychological tests [ Time Frame: baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Conners Continuous Performance Test II (CPT-II; Conners, 2000)

  • Cognitive functions measured by neuropsychological tests [ Time Frame: baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    The Hotel Task (Manly, Hawkins, Evans, Woldt, & Robertson, 2002).


Estimated Enrollment: 38
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cognitive rehabilitation Behavioral: Goal management training (GMT)
Fourteen hours of GMT during a time period of three months.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 46 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spina bifida with myelomeningocele (MMC)
  • Between 20 and 46 years of age
  • Problems in the domain of executive functioning

Exclusion Criteria:

  • Major psychiatric disorder
  • Reported alcohol or substance abuse within the past year
  • Aphasia or other specified language problems causing potential validity problems
  • IQ < 70
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302314

Locations
Norway
Sunnaas rehabilitation hospital
Oslo, Nesoddtangen, Norway, 1450
Sponsors and Collaborators
Sunnaas Rehabilitation Hospital
University of Oslo
New York University School of Medicine
The Rusk Institute of Rehabilitation Medicine
Rotman Research Institute at Baycrest
University of Toronto
Investigators
Principal Investigator: Jan Stubberud, Psychologist Sunnaas Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Jan Stubberud Ph.D. Candidate, Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01302314     History of Changes
Other Study ID Numbers: HSØ-2011041
Study First Received: February 23, 2011
Last Updated: March 1, 2011
Health Authority: Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Regional Ethics Commitee
Norway: Ministry of Health and Care Services
Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Spinal Dysraphism
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 22, 2013