Robot-Assisted Training Versus Enhanced Upper Limb training in Upper Limb Recovery following Stroke: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Motor recovery: Motor recovery will be assessed with Fugl-Meyer Assessment scale for upper extremity (FMA-UE). The FMA-UE is a widely used scale to assess UE motor impairment. The maximum possible score on the FMA-UE is 66, with higher scores indicating better motor function.
研究概览
简要总结
Upper limb (UL) rehabilitation in stroke patients remains a challenge. Many clinical trials showed significant advances in upper limb recovery with the use of a variety of sensory-motor techniques, i.e., intensive repetitive movements, functional electric stimulation, and constraint-induced movement therapy. But the recovery rates of UL rehabilitation trials are largely insignificant.
Recently, rehabilitation programs with robot-assisted devices have reported greater improvements in hand functional recovery. These robotic devices can provide consistent training with high-intensity, repetitive, and task-specific exercises with visual simulations, which conventional therapies could not provide. Patients are also motivated by the devices as they simulate real-life activities with audio-visual feedback.
After reviewing the literature, it was found that many of these trials had very small sample sizes, a large number of dropout participants, and a few studies have evaluated the functional efficacy of robot-assisted therapy on stroke rehabilitation in clinical settings. To date, no such studies have been done in Indian settings for evaluation of the effectiveness of robotic rehabilitation programs in stroke survivors.
The primary objective of the study was to compare the efficacy of robot-assisted therapy (RAT) and enhanced upper limb therapy (EULT) in UL motor recovery in stroke patients. Secondary objectives were (1) to compare the efficacy of robot-assisted therapy (RAT) and EULT in UL functional recovery, and (2) to compare the quality of life (QoL) following RAT and EULT in patients with 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
- 35.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Stroke occurred within six months
- •1st episode of stroke
- •Age between 35 to 75 years, hemodynamically stable.
- •Mild or no cognitive Deficit [Mini Mental Status Examination (MMSE) score more than 21 points)
- •Presence of minimal voluntary active shoulder (abduction and flexion) and elbow (flexion) (at least 10-20 degree active ROM at shoulder abduction and flexion and elbow movements (10-20 degree active flexion)
- •Presence of spasticity in the elbow flexors of grade one plus (1+) or more in the Modified Ashworth scale (MAS).
排除标准
- •Recurrent strokes
- •Presence of neuropathic pain in the affected upper limb
- •Presence of contractures of the affected wrist and fingers
- •Severe spasticity of the affected limb (MAS more than 3)
- •Cognitive dysfunction (Mini Mental Status Examination (MMSE) score less than 21 points)
- •Hemodynamically unstable patients
- •Presence of previous neurological disorder (due to any etiology).
结局指标
主要结局
Motor recovery: Motor recovery will be assessed with Fugl-Meyer Assessment scale for upper extremity (FMA-UE). The FMA-UE is a widely used scale to assess UE motor impairment. The maximum possible score on the FMA-UE is 66, with higher scores indicating better motor function.
时间窗: Assessments will be done at the baseline visit (V0), then at follow up visits V1, V2, and V3. (V1: 6-7 weeks follow-up, V2: 3 months follow-up, V3: 6 months follow-up).
次要结局
- Upper Limb Function: Upper limb (UL) function will be assessed with hand-function (HF) domain score of Stroke Impact Scale (SIS) and The Wolf Motor Function Test (WMFT).(Assessments will be done at the baseline visit (V0), then at follow up visits V1, V2, and V3. (V1: 6-7 weeks follow-up, V2: 3 months follow-up, V3: 6 months follow-up).)
- Quality of life (QoL): QOL will be assessed with SIS scale.(Assessments will be done at the baseline visit (V0), then at follow up visits V1, V2, and V3. (V1: 6-7 weeks follow-up, V2: 3 months follow-up, V3: 6 months follow-up).)
- Spasticity of UL: UL Spasticity will be assessed with modified Ashworth Scale (MAS) at elbow and wrist.(Assessments will be done at the baseline visit (V0), then at follow up visits V1, V2, and V3. (V1: 6-7 weeks follow-up, V2: 3 months follow-up, V3: 6 months follow-up).)
研究者
Dr Apurba Barman
AIIMS, Bhubaneswar, Odisha