Effects of Robotic Hand Therapy in Comparison to Conventional Therapy on Hand Function and Dexterity in Children With Hemiplegic Cerebral Palsy; a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Jebsen-Taylor Hand Function Test
研究概览
简要总结
This randomized controlled trial aims to evaluate the effects of robotic hand therapy using the Syrebo E12 soft-robotic glove compared with conventional physiotherapy on hand function and manual dexterity in children with hemiplegic cerebral palsy. Children aged 7-15 years, classified as GMFCS I-III and MACS I-III, will be recruited from multiple rehabilitation centers in Pakistan. Participants will be randomly allocated (1:1) to either robotic therapy or standard physiotherapy, receiving 45-minute sessions, three times per week for 8 weeks.
The primary outcome is functional hand performance measured by the Jebsen-Taylor Hand Function Test (JTHFT). Secondary outcomes include ABILHAND-Kids, Box and Block Test, Nine-Hole Peg Test, grip strength, and qualitative feedback. Assessments will occur at baseline, week 4, week 8, and at a 6-month follow-up. A mixed-effects repeated-measures ANCOVA will be used for analysis following the intention-to-treat principle.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Hemiplegic type of Cerebral palsy
- •Age 7 to 15 years
- •Ability to understand and follow simple instructions
- •Gross Motor Function Classification System (GMFCS) levels I-III (ambulatory)
- •Manual Ability Classification system (MACS) I to III
- •Stable medical condition (no major changes in medication or therapy in the past 3 months).
排除标准
- •Patients with severe cognitive dysfunction.
- •Fixed contractures or deformities of the upper limb that would prevent safe use of the robotic device.
- •Recent upper limb surgery, botulinum toxin injection, or casting within the past 6 months.
- •Uncontrolled epilepsy or other unstable medical conditions.
- •Visual or auditory impairments that would interfere with assessment or therapy.
研究组 & 干预措施
Robotic Hand Therapy
干预措施: Robotic Hand Therapy (Device)
Conventional Physical Therapy
干预措施: Conventional physical Therapy (Other)
结局指标
主要结局
Jebsen-Taylor Hand Function Test
时间窗: 8 Weeks
Jebsen-Taylor Hand Function Test (JTHFT) will objectively quantify functional capacity of hand.
次要结局
- ABILHAND-Kids(8 Weeks)
- Box and Block Test(8 Weeks)
- Nine-Hole Peg Test (NHPT)(8 weeks)
- o'connor test(8 Weeks)