Effects of Interactive Video Game-Based Exercise on Balance in Diabetic Patients With Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Change of Berg Balance Scale (BBS) score
研究概览
简要总结
This study evaluated the effects of interactive video game-based exercise (IVGB) on balance in diabetic patients with peripheral neuropathy. Twenty-four patients were randomly assigned to two groups (12 participants per group). Group A received IVGB training for the first 6 weeks, with no exercise in the subsequent 6 weeks. Group B had no exercise for the first 6 weeks and then underwent IVGB training in the subsequent 6 weeks. Both subjective and objective measures were used to determine whether IVGB exercise improves balance function.
详细描述
Participants in Group A received IVGB intervention for the first 6 weeks (intervention phase), with no exercise in the subsequent 6 weeks (control phase), whereas participants in Group B received no IVGB intervention in the first 6 weeks (control phase), followed by 6 weeks of IVGB intervention (intervention phase). The IVGB intervention protocol consisted of 30-minute training sessions comprising four tasks designed to focus on lower limb strength, balance, and coordination training. Balance assessments consisted of both subjective and objective measures, including the Modified Falls Efficacy Scale (MFES), Time Up and Go (TUG) test, Berg Balance Scale (BBS), and Unipedal Stance Test (UST). For all participants, these tests were conducted at weeks 0, 6, and 12 of the experiment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-80 years of age
- •medical diagnoses of diabetes under regular medication control and diabetic peripheral neuropathy confirmed using an electrodiagnostic test
- •independent community ambulatory individuals
- •intact cognition (Mini-Mental State Examination score of >24).
排除标准
- •other neurological diseases such as dementia, Parkinson's disease, spinal cord injury, or stroke;
- •severe visual impairment, musculoskeletal disorders, unhealed plantar ulceration, lower limb amputation, poor cardiopulmonary function, or other diseases affecting walking ability or any other disease due to which individuals were unable to walk without assistance
- •any other condition associated with a high risk of falling.
- •Inability to follow simple instructions
研究组 & 干预措施
Group A
Group A received interactive video game-based exercise training for the first 6 weeks, with no exercise in the subsequent 6 weeks. The exercise program consisted of 30-minute sessions 3 times per week for 6 weeks. Outcomes were measured at weeks 0, 6, and 12.
干预措施: interactive video game-based exercise (Other)
Group A
Group A received interactive video game-based exercise training for the first 6 weeks, with no exercise in the subsequent 6 weeks. The exercise program consisted of 30-minute sessions 3 times per week for 6 weeks. Outcomes were measured at weeks 0, 6, and 12.
干预措施: no exercise (Other)
Group B
Group B had no exercise in the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks. The exercise program consisted of 30-minute sessions 3 times per week for 6 weeks. Outcomes were measured at weeks 0, 6, and 12.
干预措施: interactive video game-based exercise (Other)
Group B
Group B had no exercise in the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks. The exercise program consisted of 30-minute sessions 3 times per week for 6 weeks. Outcomes were measured at weeks 0, 6, and 12.
干预措施: no exercise (Other)
结局指标
主要结局
Change of Berg Balance Scale (BBS) score
时间窗: 15 minutes/session; measured at weeks 0, 6, and 12 of the experiment
It consists of 14 functional tasks of varying difficulty, including sitting, standing, changing posture, transfers, reaching forward, retrieving objects, turning, tandem stance, and one-leg stance. It is a valid tool used in both clinical practice and research to evaluate the efficacy of intervention and provide a quantitative description of balance function. The ability to perform each a task is scored on a scale of 0-4, ranging from inability to independently perform the task to successfully completing it, respectively. The maximum possible score for the 14 functional tasks is 56.
次要结局
- Change of Unipedal Stance Test (UST) time(5 minutes/session; measured at weeks 0, 6, and 12 of the experiment)
- Change of Time Up and Go (TUG) test time(5 minutes/session; measured at weeks 0, 6, and 12 of the experiment)
- Change of Modified Falls Efficacy Scale (MFES) scores(10 minutes/session; measured at weeks 0, 6, and 12 of the experiment)
研究者
Lai chien hung
Professor
Taipei Medical University Hospital