Clinical trial NCT04946695: Feasibility and Efficacy of the Use of Telephysiotherapy in Anantapur
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Extremity Fracture
Keywords: telephysiotherapy
fracture
low resources
paediatrics
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This research is a quasi-experimental multicentre pre-post intervention pilot study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

This device, as well as their intervention programme ,designed thanks to the Physiotec software , will be updated weekly by the research team and the hospital physiotherapist.

The personalised programme describes the exercises to be performed, the number of sets and repetitions and the progression criteria, which will be based on published clinical guidelines for patients with lower limb fractures.

Participants and their relatives will be instructed to perform the self-training by following the exercises on video through the programme to be carried out.

The investigators will consider three types of outcomes for this research study:

- Affiliation data and demographic outcomes: Name and surname, Contact Details, Age variable and Gender variable

- Primary explanatory outcomes: Physical Function, (TUG test), Functional Independence (FIM scale), , Activities of Daily Living variables (IB) and quality of life(SF-12 questionnaire)

- Secondary explanatory outcomes.Type of injury variable ,Adherence to treatment variable , and Variable Satisfaction, Obstacles and Barriers to the use of tele-physiotherapy (ad hoc questionnaire and TSQ).

Data collection will be carried out:

T0-pre intervention :

Physical Function (TUG), Functional Independence (FIM), Activities of Daily Living (IB) and Quality of Life (SF-12). Type of injury (medical history).

T1-post intervention:

A new evaluation of the outcome variables will be carried out by adding data on barriers to use and satisfaction (ad hoc questionnaire and TSQ).

Weekly check-ups :

Adherence to treatment will be measured by the application and during by the medical service.

The fundamental ethical precepts according to the Declaration of Helsinki and Law 14/2007 of 3 July on Biomedical Research will be respected, guaranteeing the protection and confidentiality of the data in accordance with the provisions of Organic Law 3/2018, of 5 December,, on the Protection of Personal Data (LOPD).

In order to carry out the study, acceptance will be requested from the Research Ethics Committee.

A document has been drawn up that includes the Informed Consent and prior information about the research, which must be signed by the legal guardians of the participants in the study.

Be informed of the possibility to revoke the consent given at any time, without having to justify its decision and without prejudice.

This research should provide knowledge on the possibility of implementing tele-physiotherapy programmes in a low resource setting.

The possible limitations:

Misuse of devices ,Technical problems, Lack of Internet connectivity,... The appearance of selection and information biases The possible alteration of the relationship dynamic between patients and their relatives and the medical team.

Lack of improvement and positive evolution of the patient Difficulty in obtaining the necessary resources.

In conclusion, the positive results of this intervention mean that the investigators are looking at an improvement in accessibility to specialised health care, an improvement in the quality of care received and a reduction in health care costs in terms of hospital admissions, health Centre care and travel for the health care needed today in Anantapur (India).

Thank you

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

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

Primary outcomes:
measure: The Barthel Index (Functional Independence)
timeFrame: Four weeks
measure: The functional independence measure (FIM)
timeFrame: Four weeks
measure: The Timed "Up & Go" test (TUG) Functional mobility
timeFrame: Four weeks
measure: Quality of life (SF12), 12- Item Short Form Survey
timeFrame: Four weeks
Secondary outcomes:
measure: Adherence to treatment
timeFrame: Four weeks
measure: Satisfaction, Obstacles and Barriers to the use of tele-physiotherapy, Satisfaction ad hoc questionaire
timeFrame: Four weeks
measure: Satisfaction, Obstacles and Barriers to the use of tele-physiotherapy, TSQ (Telemedicine Satisfaction Questionnaire)
timeFrame: Four weeks
measure: % of patients with type of injury
timeFrame: Pre-intervention
Other outcomes:
measure: First name and surname:
timeFrame: Pre-intervention
measure: Contact Details
timeFrame: Pre-intervention
measure: Age
timeFrame: Pre-intervention
measure: Gender
timeFrame: Pre-intervention
Locations:
Study officials:
affiliation: University of Málaga (Spain)
name: María Jose MJ Estebanez- Pérez, MSC, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Estebanez-Perez MJ, Martin-Valero R, Moreno-Morales N, Linan-Gonzalez A, Fernandez-Navarro R, Pastora-Bernal JM. Digital physiotherapy intervention in children in a low resource setting in Anantapur (India): Study protocol for a randomized controlled trial. Front Public Health. 2022 Sep 30;10:1012369. doi: 10.3389/fpubh.2022.1012369. eCollection 2022.