Evaluating the Impact Rhythmic-Amplitude Motor Progression (RAMP) Protocol on Gait, Balance, Endurance, and Functional Mobility in Individuals with Diabetic Peripheral Neuropathy:A Multicentric Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 2
研究概览
简要总结
I am conducting a randomized controlled trial on individuals with diabetic peripheral neuropathy aged between 45 and 65 years. Participants will be randomly assigned to either a control group receiving standardized physiotherapy or an experimental group receiving the RAMP protocol. The intervention will be delivered for 6 weeks, three sessions per week. Outcome measures will be assessed before and after the intervention. The primary outcomes include the 10-Meter Walk Test (10MWT), 6-Minute Walk Test (6MWT), and Berg Balance Scale (BBS). The secondary outcomes include the Dynamic Gait Index (DGI), Activities-specific Balance Confidence Scale (ABC), and Timed Up and Go Test (TUG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants will include individuals who are currently on medication for diabetes.
- •Eligible participants must present sensory impairment with an MNSI score of equal or more 2.5 points and have the ability to walk household distances without assistance.
- •Additionally, participants should have ankle muscle power greater than MRC grade 3 and a Berg Balance Scale (BBS) score of more than 21.
排除标准
- •Participants will be excluded if they have a foot ulcer at the time of intake, any orthopedic condition that influences gait, or neurological problems other than diabetic peripheral neuropathy.
- •Individuals with vestibular disorders, diabetic retinopathy, or middle ear infections that may affect balance or gait will also be excluded.
- •Additionally, patients with uncontrolled cardiovascular or respiratory disorders will not be eligible to participate.
研究者
SUNJYOTH H S
college of physiotherapy , Dayananda Sagar University