Effectiveness of an intensive, functional gamified rehabilitation in improving sensory-motor and cognitive function following chronic stroke: A multicenter randomized clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The Fugl-Meyer Assessment-upper extremity (FMA) (40),
研究概览
简要总结
Stroke is a major disabling disease which affects both upper and lower limbs resulting in a wide range of impairments, activity limitations and participation restrictions. However, upper limb impairments recover slowly and the amount of recovery is less compared to the lower limb. Studies have established that an intensive, repetitive, and task specific exercise program improves upper limb function in patients with stroke even after six months. ArmAble™ which is an interactive arm rehabilitation device has been developed recently which incorporates the principles of motor learning and neuroplasticity. Therapy using ArmAble™ caters intensive, repetitive training and it is fun based, motivating, challenging and provides feedback. No studies exist on investigating the effect of low-cost gaming rehabilitation using ArmAble™ which is commercially available, functionally relevant and on the chronic stages of stroke. Therefore, the aim of this study is to determine the effectiveness of an intensive, functional, gamified rehabilitation program compared to a conventional therapy program on upper limb sensorimotor and cognitive function in people with chronic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically and or radiologically confirmed unilateral chronic stroke (more than 6 months post-stroke) diagnosed by a physician Age between 18 and 80 years Male or female participants.
- •Hemodynamically stable.
- •Stroke severity score more than 6 on the National Institutes of Health Stroke Scale Brunnstrom voluntary control grade between 1 and 5 in the affected upper limb Modified Ashworth Scale score less than or equal to 3 in the affected upper limb Ability to sit independently or with support.
排除标准
- •Global or receptive aphasia Major medical problems or co-morbidities that preclude participation, such as shoulder pain in the paretic limb, shoulder subluxation/dislocation, severe arthritis, or prior surgery resulting in functional limitation.
- •Complex regional pain syndrome Functional vision or hearing impairments that limit computer use Vestibular disorders.
结局指标
主要结局
The Fugl-Meyer Assessment-upper extremity (FMA) (40),
时间窗: Pre-intervention (T0) | Post-intervention at 2 weeks (T1) | Follow up assessment at 6 weeks (T2)
The Action Research Arm Test (ARAT) Scale (41)
时间窗: Pre-intervention (T0) | Post-intervention at 2 weeks (T1) | Follow up assessment at 6 weeks (T2)
Nottingham sensory assessment (25)
时间窗: Pre-intervention (T0) | Post-intervention at 2 weeks (T1) | Follow up assessment at 6 weeks (T2)
Montreal Cognitive Assessment Scale (MoCA) (28)
时间窗: Pre-intervention (T0) | Post-intervention at 2 weeks (T1) | Follow up assessment at 6 weeks (T2)
次要结局
- The Motricity Index (MI) scale- arm component (32),(The modified Rankin Scale (mRS) (42),)
- The Game User Experience satisfaction scale (GUESS)(Post-intervention at 2 weeks only)
研究者
Dr Senthil Kumaran D
Manipal College of Health Professions