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临床试验/CTRI/2024/07/070652
CTRI/2024/07/070652尚未招募不适用

Feasibility of telephysiotherapy on glucose control and physical performance in patients with diabetic peripheral neuropathy at tertiary care center- A Pilot Study.

Sri Devaraj Academy of higher Education and research1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年7月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
HBA1c: for measuring the blood glucose levels

研究概览

简要总结

To determine the feasibility of a tele-physiotherapy program in diabetic peripheral neuropathy (DPN) patients. The purpose of this study is to determine the clinical effects of tele physical therapy intervention on glucose control, exercise capacity, and physical performance in patients with Diabetic Peripheral Neuropathy. Several literatures reported the effectiveness of exercises in controlling the complications of diabetes mellitus. DPN results in uncontrolled diabetes mellitus, lack of physical activities, poor lifestyle, and unawareness of exercise importance. Lack of compliance for exercise sessions among diabetic neuropathy patients. During our routine physiotherapy clinical services, it has been observed that the patient’s compliance with exercise sessions was poor with challenges including commuting to the center, dependency on family members, expenditure, etc. So, a physiotherapist provides remote care services to their patients through tele communication as they recognize the benefits that telehealth can bring such as cost savings, changes in their (exercise capacity), physical performance and quality of life, greater compliance with treatment plans, and a unique opportunity for to reach social disadvantage groups where cost, geographical location or cultural barriers may limit health services. So, a lack of regular supervised exercises can increase disease complications. The improvement in technology in the health field introduced tele physiotherapy, which has been effective in treating patients with various conditions and who have challenges being physically available. With the scope of literature reviewed, we observed only one literature on the use of tele rehab in Type 2 DM, in Western countries. Hence, this study intends to explore the use and feasibility of tele physiotherapy intervention with a focus on home-based exercises and education in DPN patients. The study will be started after obtaining ethical clearance from the institutional ethical committee. Study set up - R.L. Jalappa Hospital and Research Center. DPN patients will be contacted and those who consent to the study will be recruited. The participants will be recruited based on inclusion criteria. The variables mentioned will be documented during the initial contact with the patient. The outcome measures will be HBA1c level and short physical performance battery used for assessing the blood glucose level and physical performance in patients with DPN. The duration of the study will be three months weekly 1 session so total of 12 sessions. The time and date of the session will be informed before the start of the session. The follow-up of the included participants will be done by telephonic conversation. Home-based exercise guides using online platforms will be offered for 3 months. Glucose control and physical performance will be measured at baseline and after 12 weeks of sessions on an opd visit. Supervised Home exercise sessions to control diabetes and diabetic nerve damage offered through an online platform will make it easy and feasible for DPN patients to adhere to exercises. Hence the effects of exercise performance are expected to result in better glucose control and improved physical performance which include balance, flexibility, mobility, and stability and lower extremity functional capacity.

The results of this study will also throw light on the feasibility, adherence, and effect of Tele physiotherapy as a safe and alternative treatment mode for DPN. In addition to this, telerehabilitation services can provide health benefits, and save time, labor, treatment costs, and health access for remote areas (rural communities.)

Feasibility of setting the telerehabilitation services for DPN at RLJ center. Hence future studies should include the tele physiotherapy program for chronic DM patients. All information reporting on the feasibility, cost, access to rehabilitation services, and implementation process including the barriers and facilitators of telerehabilitation.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Eligible participants with mentioned age limit, both genders, diagnosed as diabetic peripheral neuropathy using MNSI.

排除标准

  • Presence of severe cardiovascular, respiratory, and other neurological diseases Severe disability, severe balance impairments.
  • Who has visual, auditory, and cognitive impairments Those unable or unwilling to comply with the required exercise will be excluded from the study.

结局指标

主要结局

HBA1c: for measuring the blood glucose levels

时间窗: Baseline, 12 weeks

次要结局

  • Short physical performance battery (SPPB): This includes gait speed, repeated chair stand test, & standing balance test(Baseline & 12th week)

研究者

发起方
Sri Devaraj Academy of higher Education and research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Deekshitha Y S

Sri Devaraj URS Academy of Higher Education and Research

研究点 (1)

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