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临床试验/NCT07283211
NCT07283211已完成不适用

Using a NAO Robot to Enhance Occupational Therapy for Children With Cerebral Palsy

Ankara Medipol University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年1月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Quality of Upper Extremity Skills Test (QUEST)

研究概览

简要总结

Cerebral Palsy (CP) is a non-progressive neurological disorder that affects movement and posture, often impairing upper extremity function and daily activity performance. Technological tools, such as social robots, have shown promise in supporting rehabilitation. This study investigated the effects of NAO robot-assisted therapy on functional performance, motivation, and emotional states in children with unilateral CP.

Sixteen children participated in a 14-week intervention, which included 12 weeks of task-oriented therapy. In six of those weeks, sessions incorporated the NAO robot, which simulated three daily activities identified using the Canadian Occupational Performance Measure (COPM) and offered motivational feedback. Emotional responses were tracked using the Empatica E4 wristband, measuring blood volume pulse (BVP), electrodermal activity (EDA), and skin temperature (ST).

详细描述

This single-group interventional study investigated the effect of adding the social humanoid robot NAO to occupational therapy sessions on upper extremity function, hand skills, and motivation in children with unilateral spastic cerebral palsy (CP). Sixteen children aged 5-15 years, classified as GMFCS I-III, MACS 1-3, CFCS 1-2, and MAS 0-2, participated.

The study consisted of two sequential 6-week phases:

Phase 1: Routine occupational therapy sessions (40 minutes each).

Phase 2: Routine occupational therapy supplemented with NAO robot-assisted activities (same duration).

Sessions targeted functional tasks identified using the Canadian Occupational Performance Measure (COPM), such as eating, throwing a ball, and brushing teeth. Upper extremity function was assessed with the Quality of Upper Extremity Skills Test (QUEST); functional abilities with PEDI; activity limitations and bimanual hand use with GMFCS and BFMF; and occupational performance and satisfaction with COPM.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 5-15 years
  • Diagnosis of unilateral spastic cerebral palsy
  • Classified as Level I-III according to the Gross Motor Function Classification System (GMFCS)
  • Classified as Level 1-3 on the Manual Ability Classification System (MACS)
  • Level 0-2 on the Modified Ashworth Scale, indicating mild to moderate spasticity

排除标准

  • History of upper extremity orthopedic surgery within the past year
  • Presence of epileptic symptoms
  • Receipt of botulinum toxin treatment within the last six months

研究组 & 干预措施

Single Group - Occupational Therapy With and Without Social Robot Support

Experimental

This single-group arm includes all participants, who receive two sequential phases of occupational therapy. In Phase 1, children receive routine occupational therapy sessions delivered by a licensed occupational therapist. After a 2-week interval, participants enter Phase 2, during which they receive the same occupational therapy activities supplemented with robot-assisted interaction using the NAO humanoid robot. All participants experience both phases in the same order, and no randomization or group allocation is performed.

干预措施: Occupational Therapy Intervention (Other)

Single Group - Occupational Therapy With and Without Social Robot Support

Experimental

This single-group arm includes all participants, who receive two sequential phases of occupational therapy. In Phase 1, children receive routine occupational therapy sessions delivered by a licensed occupational therapist. After a 2-week interval, participants enter Phase 2, during which they receive the same occupational therapy activities supplemented with robot-assisted interaction using the NAO humanoid robot. All participants experience both phases in the same order, and no randomization or group allocation is performed.

干预措施: NAO Robot-Assisted Occupational Therapy (Other)

结局指标

主要结局

Quality of Upper Extremity Skills Test (QUEST)

时间窗: 20 minutes

Pediatric Evaluation of Disability Inventory (PEDI)

时间窗: 10 minutes

Bimanual Fine Motor Function

时间窗: 10 minutes

Canadian Occupational Performance Measure

时间窗: 10 minutes

次要结局

未报告次要终点

研究者

发起方
Ankara Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilal Bostancı Seçkin

LECTURER

Ankara Medipol University

研究点 (1)

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