Effects of an Adapted Physical Activity With an Interactive Gaming Platform on Fall Apprehension and Risk: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in the Fall Efficacy Scale-International (FES-I)
研究概览
简要总结
This study evaluates the effects of an adapted physical activity with an interactive gaming platform on fall apprehension and risks. Half of the participants will receive a rehabilitation program using the Medimoov gaming program, the other half will receive the standard rehabilitation program.
详细描述
Medimoov is an innovative interactive gaming platform offering adapted physical activity. Like most serious games, it targets both physical and cognitive components. Studies that evaluate serious games lack an appropriate control group, thus this study aims to evaluate the efficacy of serious games played with the Medimoov platform on fear of falling and fall risks. This pilot study is an open randomized controlled trial in parallel groups with blind data collection for the primary outcome.
The intervention group will follow bi-weekly sessions with Medimoov. The control group will follow the usual rehabilitation program: the standard psychomotor therapy program.
Both interventions will be consistent with rehabilitation programs prescribed by participants' physicians. Each intervention, guided by a psychomotor therapist, will last eight weeks with bi-weekly sessions of 35 minutes.
Participants will be randomly assigned to one of the two groups. Three assessments will be conducted focusing on physical and cognitive capacities. The first assessment will be conducted five or fewer days before the beginning of the rehabilitation program, the second will occur during week 4 and the third one during week 8, at the end of the rehabilitation program. Assessments will be blinded: assessors will not know the assigned group of each participant.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be at least 65 years old,
- •To be able to give consent,
- •French-speaking,
- •To be able to stand upright in a bipedal position, feet together for a time greater than 10 seconds with/without an assistive device,
- •To have a score ≥13 on the Short Fall Efficacy Scale (FES-I) (moderate fear of falling).
排除标准
- •Not being able to answer the questionnaires,
- •Not being able to correctly distinguish the elements on the screen,
- •To be in palliative care,
- •To be under a legal protection measure,
- •To score under 16 at the Mini Mental State Examination,
- •To have an acute pathology,
- •To have had recent hip surgery (<2 months).
结局指标
主要结局
Change in the Fall Efficacy Scale-International (FES-I)
时间窗: Before, at mid-term (Week 4) and at the end of the program (Week 8).
This five-minute questionnaire is composed of seven questions on daily activities and focus on the fear of falling. Each question can be scored between 1 (" Not at all concerned ") to 4 points (" Very concerned "). Higher scores mean a worse outcome.
Change in the Score Physical Performance Battery
时间窗: Before, at mid-term (Week 4) and at the end of the program (Week 8).
This 5-minute test focuses on the static balance, walks, lower limb strength and fall risk. The score varies between 0 and 12, a score under 6 indicates a low performance and a high fall risk. Higher scores mean a better outcome.
次要结局
- Change in the Trail Making Test A and B(Before, at mid-term (Week 4) and at the end of the program (Week 8))
- Change in the Victoria Stroop test(Before, at mid-term (Week 4) and at the end of the program (Week 8))
- Change in the One-Leg Stand test(Before, at mid-term (Week 4) and at the end of the program (Week 8))
- Change in the Timed Up And Go(Before, at mid-term (Week 4) and at the end of the program (Week 8))
- Satisfaction questionnaire(At the end of the program (Week 8))
研究者
Joel Belmin
Professor
RIVAGES