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临床试验/NCT04946695
NCT04946695Unknown不适用

Feasibility and Efficacy of the Use of Telephysiotherapy for Improving Functional Independence and Quality of Life in Children and Young People With Lower Limb Fracture in a Low Resource Setting in Anantapur (India)

University of Malaga0 个研究点目标入组 30 人开始时间: 2021年7月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
The Barthel Index (Functional Independence)

研究概览

简要总结

Injuries remain the most frequent cause of mortality in children and young people. Studies with: telephysiotherapy programmes have published results of effectiveness, validity, non-inferiority and important advantages, providing an opportunity to define new health and social intervention policies.

In rural regions such as Anantapur, there are few physiotherapists compared to the potential need; innovative strategies are needed to improve access to more specialised physiotherapy care. There is also a significant paucity of studies in low resources geographies, making this research highly justified.

This research is a quasi-experimental multicentre pre-post intervention pilot study in a population aged 5-16 years with a diagnosis of lower limb fracture in Anantapur (India).

The main objective is to assess the feasibility and efficacy of using a 4-week personalised telephone therapy programme, as well as adherence, identify barriers to use and satisfaction with the intervention.

Subjects will receive a baseline assessment (T0-pre) obtaining data on Physical Function (TUG), Functional Independence (FIM), Activities of Daily Living (ADL) and Quality of Life (ISF-12). At the end of the intervention (T1-post) a new evaluation of the outcome variables will be carried out by adding data on adherence, barriers to use and satisfaction (ad hoc questionnaire and TSQ).

This research should provide insights into the possibility of implementing telephone therapy programmes in hospital settings in low resources areas.

详细描述

This research is a quasi-experimental multicentre pre-post intervention pilot study in a population aged 5-16 years with a diagnosis of lower limb fracture in Anantapur (India).For the development of this research a non-probabilistic purposive sampling will be used for the convenience of the study, n=30

The main objective is to assess the feasibility and efficacy of using a personalised telephysiotherapy programme for improving functional independence and quality of life in children and young people with lower limb fracture in a low resource setting in Anantapur.

Secondary objectives:- To assess the frequency and distribution of injuries among study subjects.- To evaluate the satisfaction with the telephysiotherapy programme in rural areas with low resources of the participants. - To analyze the degree of adherence to the telephysiotherapy treatment.- To identify obstacles and possible barriers in the development of the intervention.

Participants in the study will receive a personalised telephysiotherapy programme adapted to their injury for 4 weeks.

For the monitoring of the telephysiotherapy programme, the participants will receive a free recycled mobile device.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children (aged 5-16 years) living in rural areas with referral hospitals Bathalapali and Kaliandur.
  • Diagnosed by the medical team of these hospitals with lower limb fracture.
  • Children and/or responsible family members must have reading and writing skills in English or Telugu (language of the Anantapur region).

排除标准

  • Presence of a diagnosis of neurological, mental or infectious disease, cognitive disorder and/or comorbidities to musculoskeletal involvement.

结局指标

主要结局

The Barthel Index (Functional Independence)

时间窗: Four weeks

Independence in self-care and mobility; it assesses the patient's level of independence with respect to the performance of some basic activities of daily living (ADLs), whereby different scores are assigned. Provides information both from the global score and from each of the partial scores for each activity. This helps to gain a better understanding of the person's specific impairments and facilitates the assessment of their evolution over time. The total score is reached by adding up the scores for each measurement and predicts the time and help that the patient will require. Scores can range from zero to 100, adding up to five points per category, so that higher scores indicate a greater degree of functional independence. It is an easy to apply measure, with a high degree of reliability and validity, capable of detecting changes, easy to interpret, and is not bothersome to apply.

The functional independence measure (FIM)

时间窗: Four weeks

A global ordinal scale for functional assessment (mobility and self-care) is useful in making decisions about the effectiveness of therapy. Several studies have used the FIM to investigate treatment outcome in self-care, transfers (mobility) and locomotion. The FIM uses a 7-level scale to rate functional performance. The total FIM score is obtained by summing the ratings of the 18 items included in the different levels. The scale has good reliability and its comparison with other instruments yields correlations of 0.84 with the Barthel Index.

Quality of life (SF12), 12- Item Short Form Survey

时间窗: Four weeks

The SF-12 questionnaire will be used for the assessment of health-related quality of life. The SF-12 questionnaire assesses eight dimensions of health-related quality of life: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health. The range of scores obtained is from 0 to 63 points. High internal consistency indices are observed both in the Spanish validation of the questionnaire 0.83 and 0.9039, as well as in several international studies.

The Timed "Up & Go" test (TUG) Functional mobility

时间窗: Four weeks

The original Get-up and Go test was intended to clinically assess dynamic balance in older people during the performance of a task involving fall-critical situations. The TUG test measures, in seconds, the time required for an individual to get up from a standard chair with armrests (approximately 46 cm high), walk 3 m, turn around, return to the chair and sit down again. The test has been widely used in clinical practice as an outcome measure to assess functional mobility, fall risk or dynamic balance in adults. The TUG test, proved to be a good tool for assessing functional mobility in the paediatric. Assessment in seconds, ranging from less than 10 seconds considered as independent mobility to more than 20 seconds considered as reduced mobility.

次要结局

  • Satisfaction, Obstacles and Barriers to the use of tele-physiotherapy, TSQ (Telemedicine Satisfaction Questionnaire)(Four weeks)
  • Adherence to treatment(Four weeks)
  • % of patients with type of injury(Pre-intervention)
  • Satisfaction, Obstacles and Barriers to the use of tele-physiotherapy, Satisfaction ad hoc questionaire(Four weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Jose Estebanez Perez

Feasibility and Efficacy of the Use of Telephysiotherapy in Anantapur

University of Malaga

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