Cognitive Rehabilitation in Patients With Spina Bifida: Effects on Executive Functions, Psychological and Health Related Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- self report of cognitive failures
研究概览
简要总结
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.
详细描述
INTRODUCTION:
Rationale and purpose:
Rehabilitation of impaired cognitive processes has come to be a standard component of medical care after traumatic brain injury (TBI) or stroke (Cicerone, Dahlberg, Malec, Langenbahn, Felicitti, Kneipp, et al., 2005), and sometimes for patients with infections of the brain, hypoxic brain damage, and progressive conditions (Wilson, 2008).
The objective of this study is to determine the effects of a recently developed cognitive rehabilitation program; Goal Management Training (GMT) on the executive functioning in people with SB that have cognitive complaints. To date, research efforts have only focused on categorizing cognitive impairments in SB with no research directed towards rehabilitation for these impairments. Given the extent, nature, and ramifications of cognitive impairments in SB, studies on compensatory-based cognitive rehabilitation that teaches management strategies such as GMT may be beneficial for this population. The research questions in this study are (1) What effect does GMT have on cognitive executive functions? Furthermore, what effect does GMT have on subjective and informant evaluation of executive functioning? (2) What effect does GMT have on mental health and quality of life? (3) What effect does GMT have on coping strategies? There will be a 6 months follow-up with regard to the research questions. It is expected that GMT will have a favourable effect on executive functioning, psychological and health related factors in patients with SB.
BACKGROUND:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 46 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spina bifida with myelomeningocele (MMC)
- •Between 20 and 46 years of age
- •Problems in the domain of executive functioning
排除标准
- •Major psychiatric disorder
- •Reported alcohol or substance abuse within the past year
- •Aphasia or other specified language problems causing potential validity problems
结局指标
主要结局
self report of cognitive failures
时间窗: baseline, 3 months, and 6 months
Cognitive Failures Questionnaire (Broadbent, Cooper, FitzGerald, \& Parkes, 1982).
Self and informant report of cognitive difficulties
时间窗: Baseline, 3 months, and 6 months
The Dysexecutive Questionnaire (DEX; Burgess, Alderman, Emslie, Evans \& Wilson, 1996).
self report of psychological problems
时间窗: baseline, 3 months, and 6 months
Symptom Checklist 25 (SCL-25; Derogatis, 1994).
self report of quality of life
时间窗: baseline, 3 months, and 6 months
SF36 (Ware \& Sherbourne, 1992).
Self report of coping strategies
时间窗: baseline, 3 months, and 6 months
General Coping Questionnaire (GCQ-30; Joseph, Williams \& Yule, 1992a).
次要结局
- Cognitive functions measured by neuropsychological tests(baseline, 3 months and 6 months)
研究者
Jan Stubberud
Neuropsychologist and PhD student
Sunnaas Rehabilitation Hospital