A Pilot Study of Neuro Hand Orthosis Program: A Promising Restorative Therapy Treatment for the Severe Paralytic Arm in Subacute Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
The implementation of Neuro Hand Orthosis Upper Limb Program can significantly improve the severe stroke paralytic arm in subacute rehabilitation as compared with the use of conventional therapy.
详细描述
The neuro hand orthosis is based on a design of dynamic hand orthosis for orthopaedic patients. We attempt to apply such an orthosis on stroke patients to aid in regaining movement from severe paralytic arm by helping the patients to support their wrist and finger in a functional position for grasping. The patient is then encouraged to produce voluntary movement from the severe paralytic arm to transport an object (ball) from place to place either in sitting or standing position.
Since intensive arm usage is associated with neuro reorganisation, we propose designing a program with the neuro hand to encourage usage of the paralysed hand and help overcome the barriers of poor motivation and lack of arm usage through self practice program.
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
- 50 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post stroke between one week to three months and medically stable
- •Right Hemiplegia with right hand dominant
- •Able to stand with minimum assistance
- •AMT score not lesser then 7/10
- •Motricity Index Arm Score <36/100
排除标准
- •Unable to commit to the Neuro Hand Orthosis Program (either as in or out patients) for 10 weeks according to the program regime or unable to follow the control group regime for 10 weeks
- •Pre-existence shoulder or upper limb pain
- •Pre-existence moderate or severe hand oedema
- •Patients with terminal disease
- •Resident of Institution (eg, Nursing home etc prior to admission)
- •Pre-existing upper limb disability on affected arm
- •Psychiatric problem
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: week 4 , week 10 , 6 months and 12 months
Motricity Index
时间窗: week 4 , week 10 , 6 months and 12 months
次要结局
- Modified Ashworth Scale for grading Spasticity(At admission, week 4 , week 10 , 6 months and 12 months)
- Shoulder pain at admission(At admission, week 4 , week 10 , 6 months and 12 months)
- Motor Activity Log (MAL)(At admission, week 4 , week 10 , 6 months and 12 months)