Comparison of Tenascin-C Value Rates and Functional Outcomes Between Exergame Therapy and Robotic Therapy in Post-Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Nine Hole Peg Test Value
研究概览
简要总结
This clinical trial aims to compare the effectiveness of Robotic versus Exergame versus Standard therapy to improve hand function among post-stroke patients. The main questions it aims to answer are:
1, Effectiveness of interventions in functional outcome recovery across time 2. Effectiveness of interventions in affecting Tenascin-C level 3. Clinical outcome difference between all interventions
Participants will be allocated into three groups, either a robotic group, exergame group as the main interventions, and standard rehabilitation group as the active comparator. A serial follow-up will be conducted to assess the selected clinical outcome and differences in outcome
详细描述
1, Research design This research is an experimental study with a randomized controlled trial research design.
2. Study Setting The research will be carried out among post-stroke patients at two teaching hospitals and one physical rehabilitation center in Makassar
3. Procedure
a. Standard Rehabilitation Comprehensive medical management and rehabilitation of disabilities caused by stroke through the neurorehabilitation approach with the aim of optimizing recovery and or modifying existing remaining symptoms so that stroke people are able to carry out functional activities independently, can adapt to the environment and achieve quality life
b. Exergame Physical exercise of the entire body carried out through active video games that require gross motor skills, visual-spatial coordination, balance, and energy expenditure that are proportional to the intensity of moderate physical activity
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigator will be masked from the allocation as well as outcome assessor
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients after ischemic or hemorrhagic stroke
- •stable hemodynamics and neurologic state.
- •Patients have never undergone treatment with any intervention
- •Able to watch television with or without glasses from a distance of 1 meter.
- •Patients can understand informed consent to participate in research
排除标准
- •Patients with a history of seizures or epilepsy.
- •Patients with severe cognitive disorders that can interfere with research objectives (MMSE score <24).
- •Patients with field deficits or severe vision disorders.
- •The patient is unable to sit upright without help.
- •Patients with significant pain in the affected upper limb.
- •Patients with significant sensory decreases in the upper limb that are affected
- •Patients with other medical conditions (musculoskeletal, neuromuscular, cardio respiration) are uncontrolled and are at risk of disrupting the ability to exercise.
- •Dropout Criteria
- •Patients who were declared dead
- •Refusing to continue the training session or less < 50% of all sessions.
- •Experiencing hemodynamic and neurological disorders during the training program process.
- •Experiencing cybersickness twice in successive training sessions
结局指标
主要结局
Nine Hole Peg Test Value
时间窗: changes of NHPT values from pre-intervention to six weeks after intervention
an assessment for finger dexterity and coordination where the time of the subject to accomplish task will be recorded. Average healthy adult male completed the NHPT in 19.0 seconds (SD 3.2) with the right hand, and in 20.6 seconds (SD 3.9) with the left hand. For healthy adult women, the NHPT was completed in 17.9 seconds (SD 2.8) and 19.6 seconds (SD 3.4) with the right and left hands, respectively.
Handgrip Dynamometer value
时间窗: changes of handgrip values from pre-intervention to six weeks after intervention
The handgrip dynamometer measures hand strength, with a typical range of 0 to 100 kg (0 to 220 lb). For men, normal handgrip strength usually falls between 30-60 kg (66-132 lb), while for women it ranges from 20-40 kg (44-88 lb).
Fugl-Meyer Assessment Upper Extremity (FMA-EU) Score
时间窗: changes of FMA-UE score from pre-intervention to six weeks after intervention
a motoric assessment with each score range from 0-2 with a total score range from 0-66. Higher score indicates better and free movement
Tenascin-C value
时间窗: changes of Tenascin-C value from pre-intervention to six weeks after intervention
The normal range of Tenascin-C levels in healthy individuals typically falls between 50 to 200 ng/mL.
次要结局
未报告次要终点
研究者
Bumi Herman
Lecturer
Hasanuddin University