Long-Term Effect of Motor-Cognitive Intervention on Functioning based on ICF Framework in Adolescents with Juvenile Diabetes: A 12-Month Experimental Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Balance:
研究概览
简要总结
Study setting is
-
MGM School of Physiotherapy, Chh Sambhajinagar.
-
Udaan Empowering Children with Type 1 Diabetes, NGO, Chh Sambhajinagar
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
- 12.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Adolescents aged 12–18 years diagnosed with Type1 diabetes mellitus for at least 6 months, Primary Care givers of these adolescents, Willingness to participate and provide informed consent/assent.
排除标准
- •Adolescents or caregivers with diagnosed significant cognitive impairments, Non- consenting adolescents or caregivers.
结局指标
主要结局
Balance:
时间窗: Baseline, 3 months, 6 months,12 months
Physical Function:
时间窗: Baseline, 3 months, 6 months,12 months
•Flexibility: Sit and Reach Test
时间窗: Baseline, 3 months, 6 months,12 months
•
时间窗: Baseline, 3 months, 6 months,12 months
Strength: Hand Grip Strength
时间窗: Baseline, 3 months, 6 months,12 months
Endurance: Shuttle Run Test
时间窗: Baseline, 3 months, 6 months,12 months
Cognitive Function:
时间窗: Baseline, 3 months, 6 months,12 months
•Wechsler Intelligence Scale for Children (WISC-V)
时间窗: Baseline, 3 months, 6 months,12 months
Fine Motor Skills:
时间窗: Baseline, 3 months, 6 months,12 months
Bruininks-Oseretsky Test of Motor Proficiency (BOT-2)
时间窗: Baseline, 3 months, 6 months,12 months
•Pediatric Berg Balance Scale
时间窗: Baseline, 3 months, 6 months,12 months
Social and Physical Participation:
时间窗: Baseline, 3 months, 6 months,12 months
•Pediatirc Quality of Life Inventory (PedsQL)
时间窗: Baseline, 3 months, 6 months,12 months
•Children’s Assessment of Participation and Enjoyment (CAPE)
时间窗: Baseline, 3 months, 6 months,12 months
次要结局
- Personal Factors(•Glycemic Level)
研究者
Chayarani Bora
Assistant Professor, Department of Neurophysiotherapy,MGM School of Physiothreapy, Chh. Sambhajinagar,a Constituent Unit of MGM Institute of Health Sciences, Navi Mumbai