Lower Extremity FractureTelefisioNCT04946695
Feasibility and Efficacy of the Use of Telephysiotherapy in Anantapur
A study testing Telefisio India in people with Lower Extremity Fracture, run by University of Malaga.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Lower Extremity Fracture
- What is being tested?
- Telefisio India
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- Presence of a diagnosis of neurological, mental or infectious disease, cognitive disorder and/or comorbidities to musculoskeletal involvement.
Trial locations and contacts
No sites are listed yet.
About this study
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)
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.
Read more
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.
Read the 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
- Conditions
- Lower Extremity Fracture
- Being tested
- Telefisio India
- Keywords
- telephysiotherapy, fracture, low resources, paediatrics
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telefisio IndiaOther
Also called Improving functional independence and quality of life in low-income areas
Implement telephysiotherapy programmes in low-resource areas.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Telefisio India |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Four weeks
Secondary outcomes (4)
Adherence to treatment
The telephone therapy application automatically records compliance with the scheduled sessions, as well as the non-compliance with the protocol indicated by the physiotherapist. This adherence is completed by the weekly control with the physiotherapist at the reference hospital, who will record attendance at the sessions.
Measured: Four weeks
Satisfaction, Obstacles and Barriers to the use of tele-physiotherapy, Satisfaction ad hoc questionaire
The investigators will use a questionnaire designed Ad hoc which includes a Likert scale (1 Dissatisfied - 5 Very satisfied), and open questions for the patient and relatives to point out the possible obstacles and barriers in the use of TelePhysiotherapy.
Measured: Four weeks
Satisfaction, Obstacles and Barriers to the use of tele-physiotherapy, TSQ (Telemedicine Satisfaction Questionnaire)
The TSQ is a 14-item questionnaire in its final version, the questionnaire items are scored on a five-point scale, from 1 being strongly disagree to 5 being strongly agree.. The internal consistency of the TSQ was 0.93, which is considered acceptable and indicates strong correlations between the items that make up the scale. Predictive validity supported the conclusion that the TSQ measured patient satisfaction with telemedicine (Pearson's correlation coefficient (r=0.45, P<0.05) (36).
Measured: Four weeks
% of patients with type of injury
The investigators will estimate this as a nominal qualitative variable; this variable coincides with the diagnosis provided by their doctor in one of the reference hospitals.
Measured: Pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start15 Jul 2021 (estimated)
- Primary completion15 Sep 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This research is a quasi-experimental multicentre pre-post intervention pilot study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Jose Estebanez Perez, University of Malaga
- Investigators
- María Jose MJ Estebanez- Pérez, MSC, PT, Principal investigator, University of Málaga (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946695
- Sponsor's protocol ID
- 15031973
- Acronym
- Telefisio
- Status last verified
- Jun 2021
- First submitted
- 10 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36249182
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04946695
- Acronym / sponsor ID
- Telefisio / 15031973
- Conditions
- Lower Extremity Fracture
- Keywords
- telephysiotherapy, fracture, low resources, paediatrics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 15 Jul 2021 (estimated)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This research is a quasi-experimental multicentre pre-post intervention pilot study
| Arm | Type | Receives |
|---|---|---|
| Telefisio India | Experimental | Other: Telefisio IndiaFeasibility 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). |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Presence of a diagnosis of neurological, mental or infectious disease, cognitive disorder and/or comorbidities to musculoskeletal involvement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telefisio IndiaAlso: Improving functional independence and quality of life in low-income areasImplement telephysiotherapy programmes in low-resource areas. | Other | Telefisio India |
Primary outcome
The Barthel Index (Functional Independence)
Time frame: 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)
Time frame: 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.
The Timed "Up & Go" test (TUG) Functional mobility
Time frame: 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.
Quality of life (SF12), 12- Item Short Form Survey
Time frame: 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.
4 secondary outcomes
Adherence to treatment
Time frame: Four weeks
Satisfaction, Obstacles and Barriers to the use of tele-physiotherapy, Satisfaction ad hoc questionaire
Time frame: Four weeks
Satisfaction, Obstacles and Barriers to the use of tele-physiotherapy, TSQ (Telemedicine Satisfaction Questionnaire)
Time frame: Four weeks
% of patients with type of injury
Time frame: Pre-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Derived from this study: PubMed 36249182Estebanez-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.
- Individual participant dataSharing planned: No
Related trials for Lower Extremity Fracture
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Recruiting
Investigating Auto Adjusting Dynamic AFO
Lower Limb; Fusion, Congenital, Lower Limb Fracture
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Jose MJ Estebanez- Pérez, MSC, PT principal investigator
University of Málaga (Spain)
Questions about this trial
What is this clinical trial studying?
A study testing Telefisio India in people with Lower Extremity Fracture, run by University of Malaga.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Jose MJ Estebanez- Pérez, MSC, PT (658561621, mariajoseestebanezperez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Barthel Index (Functional Independence) (time frame: Four weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04946695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.