Effect of Transcranial Direct Current Stimulation on Risk of Falling in Cerebral Palsy Spastic Hemiplegic Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The Fall Risk test
研究概览
简要总结
The purpose of this study was to determine:
- If there is an effect of transcranial direct current stimulation in improvement the functional balance in CP spastic hemiplegic children.
- If there are any changes in risk of falling in CP spastic hemiplegic children or not.
详细描述
With the decline of mobility comes a drastic increase in falling. However, people of all ages with cerebral palsy can fall easily due to imbalance issues and non-voluntary movements. Individuals with cerebral palsy (CP) can experience a variety of sensorimotor impairments that impact balance, making excessive tripping and falling among the most common concerns for ambulatory individuals with CP. Approximately 53-97% of ambulatory individuals fall at least once per year, causing injury, embarrassment, frustration, activity avoidance, and isolation. Although a study of over 1000 children found fall frequency was highest in gross motor function classification system (GMFCS) level II, research has not explored if this holds across the decades of adulthood.
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
- Single (Participant)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range between 8-12 years old.
- •Classified on levels II and III of the Gross Motor Function Classification System (GMFCS) (Palisiano et al.,1997).
- •the ability to walk without the assistance of another individual for at least 12 months prior to the onset of the study, regardless of whether a gait-assistance device was needed (GMFCS level III) or not (GMFCS level II).
- •(Pediatric Balance Scale, Timed Up and Go Test 'TUGT') and acceptance of the TDCS procedure.
- •Ability to understand and follow simple instructions.
- •Parent or guardian consent obtained
排除标准
- •Orthopedic deformities, a history of surgery or neurolytic block in the previous 12 months,
- •Diagnosis of epilepsy or having experienced convulsive crises (whether treated with medication or not) in at least the two years prior to the onset of the study, metal implants in the skull, or the use of hearing aids.
- •Previous participation in a tDCS study within the past 6 months.
研究组 & 干预措施
Group 1
will receive selected traditional physical therapy program for improve balance and decrease risk of falling only.
干预措施: Transcranial direct current stimulation (Device)
Group 1
will receive selected traditional physical therapy program for improve balance and decrease risk of falling only.
干预措施: Exercise (Other)
Group 2
will receive transcranial direct current stimulation plus selected traditional physical therapy program.
干预措施: Exercise (Other)
结局指标
主要结局
The Fall Risk test
时间窗: From enrollment to the end of treatment at 8 weeks
The fall risk test allowed identification of potential fall candidates. Test results were compared to age dependent normative data. Scores higher than normative values suggested more fall risk index
次要结局
未报告次要终点
研究者
Dr. Ahmed Fathy Mahmoud Awd
Physiotherapist
Cairo University