Feasibility and Efficacy of the Use of Telephysiotherapy in Anantapur

NCT04946695 | Unknown

• 1 other identifier: 15031973
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lower Extremity Fracture

Keywords

telephysiotherapy; fracture; low resources; paediatrics

Outcome Measures

Primary Outcomes (4)

• The Barthel Index (Functional Independence)

  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.

  Four weeks

• The functional independence measure (FIM)

  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.

  Four weeks

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

  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.

  Four weeks

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

  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.

  Four weeks

Secondary Outcomes (4)

• Adherence to treatment

  Four weeks

• Satisfaction, Obstacles and Barriers to the use of tele-physiotherapy, Satisfaction ad hoc questionaire

  Four weeks

• Satisfaction, Obstacles and Barriers to the use of tele-physiotherapy, TSQ (Telemedicine Satisfaction Questionnaire)

  Four weeks

• % of patients with type of injury

  Pre-intervention

Other Outcomes (4)

• First name and surname:

  Pre-intervention

• Contact Details

  Pre-intervention

• Age

  Pre-intervention

Study Arms (1)

Telefisio India

EXPERIMENTAL

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).

Other: Telefisio India

Interventions

Telefisio India OTHER

Implement telephysiotherapy programmes in low-resource areas.

Also known as: Improving functional independence and quality of life in low-income areas

Telefisio India

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaga: lead

Related Publications (1)

• 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.

  PMID: 36249182 DERIVED

MeSH Terms

Conditions

Fractures, Bone

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• María Jose MJ Estebanez- Pérez, MSC, PT

  University of Málaga (Spain)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María Jose MJ Estebanez- Pérez, MSC, PT

CONTACT

658561621; mariajoseestebanezperez@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Feasibility and Efficacy of the Use of Telephysiotherapy in Anantapur

Model Details: This research is a quasi-experimental multicentre pre-post intervention pilot study

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: July 1, 2021
• Study Start: July 15, 2021
• Primary Completion: September 15, 2021
• Study Completion: January 31, 2022
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share