Effectiveness of an App based Cognitive Intervention Program for Cognitive Rehabilitation Training in Adult Patients with Brain Tumors in a Tertiary Care Setting: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary Objective: To evaluate the Effect on Cognitive Function
研究概览
简要总结
Participants will be divided randomly into 2 groups.
The control group will not be receiving the computerized intervention whereas the experimental group will be receiving the computerized intervention program. The study population will consist of patients with brain tumours who have completed the medical treatment at Tata Memorial Centre.
The Control group will receive Non-Computerized Interventions for a duration of 45 minutes/session, 3 sessions/week for 12 weeks which will include 1) Attention process Training including Letter Cancellation and Sorting Task.2) Restorative Approaches for Memory which will include 5-digit recall and Image recall 3) Problem Solving Training through the use of 10-piece non-computerized picture puzzle. This group will also receive Deep Breathing Exercises, Conditioning Exercises and Motor Retraining.
The Experimental Group will receive intervention for a duration of 45 + 30 minutes which will include Cognitive Interventions through Non-Computerized Intervention 1) Attention process Training including Letter Cancellation and Sorting Task.2) Restorative Approaches for Memory which will include 5-digit recall and Image recall 3) Problem Solving Training through the use of 10-piece picture puzzle. This group will also receive Deep Breathing Exercises, Conditioning Exercises and Motor Retraining. In addition, the experimental group will receive a 12-week cognitive intervention training program will involve the use of Cognifit which consists of cognitive facilitation games which are directed at Attention, Memory, Processing Speed and Executive Functions administered over three sessions per week where each session is of 30-minute duration.
Evaluation of outcomes will be assessed at first visit and at end of every 4th week. Mean scores, percentages of cognitively impaired individuals will be compared between the groups.
In addition, a feasibility form will be administered to obtain the feedback of the patient and caregiver users on the convenience of use of the app-based intervention program
Each participant is expected to available at the Occupational Therapy Outpatient Department for 3 sessions per week for 12 weeks. If you are in the control group, each session will last for about 45 minutes. If you are in the experimental group, each session would be for a duration of 45 and 30 minutes totaling to 1 hour 15 min.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •This study will include Patient Participants with benign or malignant primary brain tumor who are of age above 18 years with a MoCA score between 10 -25 (Mild & Moderate Cognitive Impairment).
- •Patients who have completed Radiation Therapy will be taken.
- •Participants should be able to read and understand Basic English Language and should be of ECOG status 0,1 or 2.
排除标准
- •Exclusion Criteria: This study will exclude participants of age less than 18 with metastatic Brain Tumor or presence of any psychiatric illness.
- •Patients with MoCA score 26 or above 26 will not be included.
- •Severe Cognitive Impairment will not be included.
- •Poor general condition and an ECOG status of 3 or 4 will not be included.
结局指标
主要结局
Primary Objective: To evaluate the Effect on Cognitive Function
时间窗: Baseline 4weeks 8weeks 12weeks
次要结局
- To assess the impact of Computerized Cognitive Intervention on the Quality of Life of individuals with brain tumors(BASELINE 4WEEKS 8 WEEKS 12 WEEKS)
研究者
Dr Jagmohan Lal Meena
Advanced Centre for Treatment Research and Education in Cancer