Assessment of Muscle Force IrradiationPhase 1NCT02255708
Effects of an Intervention Program by Proprioceptive Neuromuscular Facilitation, in Muscle Force Irradiation.
A Phase 1 study testing Proprioceptive Neuromuscular Facilitation - PNF in people with Assessment of Muscle Force Irradiation, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The present study aims to assess through surface electromyography, the effectiveness of proprioceptive neuromuscular facilitation protocols in the activation of the stabilizing muscles of the scapula and the anterior tibial muscle. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Assessment of Muscle Force Irradiation
- What is being tested?
- Proprioceptive Neuromuscular Facilitation - PNF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to Aug 2015
- Phase
- Phase 1
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals group: who agree to participate in the study with no history of previous trauma or disease of the shoulder girdle, with absence of clinical signs painful in the shoulder joint.
- Group with demyelinating polyneuropathy: both sexes, carriers of CMT-1A disease with functional changes in the lower limbs with good cognition and difficulty of to ambulate with and without assistance.
Who cannot join
- Healthy individuals group: subject with restricted range of motion, muscle weakness, cognitive impairment, which exhibits a pathology that leads to alterations in muscle recruitment.
- Patients with polyneuropathy: cardiac arrhythmias, uncontrolled hypertension, severe cardiovascular disease and respiratory problems. The use of own medicines to treat pathology was accepted.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratory of Neuropsychobiology and Motor Behavior,
Ribeirão Preto, São Paulo
Ana Cláudia s Ferreira, graduate student, +55-16-988027661, acsilvaf35@gmail.com
João Eduardo Araujo, lecturer, +55-16-6024416, araujoje@fmrp.usp.br
About this study
Official title: Electromyography Evaluation of the Stabilizing Muscles of the Scapula and Tibial Anterior Muscle, After an Intervention Program by Proprioceptive Neuromuscular Facilitation in Muscle Force Irradiation.
The present study aims to assess through surface electromyography, the effectiveness of proprioceptive neuromuscular facilitation protocols in the activation of the stabilizing muscles of the scapula and the anterior tibial muscle.
Read the detailed description
Healthy subjects and subjects with demyelinating polyneuropathy are involved in the study.
Healthy patients are arranged in two groups of stimulation: FNP Group (intervention proprioceptive neuromuscular facilitation) - CC Group (intervention classic cinesioterapia). The electromyographic response of the stabilizing muscles of the scapula of each individual will be assessed prior to application of the protocols, during the execution of the protocols and immediately after stopping in a single session.
Patients with demyelinating polyneuropathy are arranged in a single treatment group and will be treated at a frequency of twice a week for five weeks. In each session, the PNF patterns will be repeated four times, on both sides, stimulating muscle irradiation and evoking the contraction of the tibialis anterior muscle. During the repetition of the patterns, the dorsiflexor muscle response of each patient will be obtained by an electromyography (EMG) surface.
The data of the RMS values obtained in the first session will be normalized and transformed into percentage. The average RMS of each diagonal at the beginning of treatment corresponds to 100% of TA muscle activation. The RMS values obtained in the last session will be normalized as a percentage, taking into account the results of the first evaluation. After normalization, data from the first and last sessions will besubjected to the for paired t-test.
- Conditions
- Assessment of Muscle Force Irradiation
- Being tested
- Proprioceptive Neuromuscular Facilitation - PNF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular Facilitation - PNFOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy group. | Other | Group formed by healthy patients. Receives: Other: Proprioceptive Neuromuscular Facilitation - PNF |
| Group with demyelinating polyneuropathy | Other | Group formed by patients with demyelinating polyneuropathy. Receives: Other: Proprioceptive Neuromuscular Facilitation - PNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of muscle force irradiation, through surface electromyography.
Irradiation of muscle strength will be assessed using surface electromyography, which shows the activation or not of the muscles evaluated.
Measured: This evaluation of patients is performed in only one day, being made before, during and after the application of the protocols. It is estimated that the results are collected in one years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of Muscle Force IrradiationStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Cláudia Silva Ferreira, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255708
- Sponsor's protocol ID
- U1111-1161-5560
- Status last verified
- Sep 2014
- First submitted
- 23 Sep 2014
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyography Evaluation of the Stabilizing Muscles of the Scapula and Tibial Anterior Muscle, After an Intervention Program by Proprioceptive Neuromuscular Facilitation in Muscle Force Irradiation.
- ClinicalTrials.gov ID
- NCT02255708
- Acronym / sponsor ID
- U1111-1161-5560
- Conditions
- Assessment of Muscle Force Irradiation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2015 (estimated)
- First posted
- 2 Oct 2014 (estimated)
- 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.
The present study aims to assess through surface electromyography, the effectiveness of proprioceptive neuromuscular facilitation protocols in the activation of the stabilizing muscles of the scapula and the anterior tibial muscle.
Detailed description
Healthy subjects and subjects with demyelinating polyneuropathy are involved in the study.
Healthy patients are arranged in two groups of stimulation: FNP Group (intervention proprioceptive neuromuscular facilitation) - CC Group (intervention classic cinesioterapia). The electromyographic response of the stabilizing muscles of the scapula of each individual will be assessed prior to application of the protocols, during the execution of the protocols and immediately after stopping in a single session.
Patients with demyelinating polyneuropathy are arranged in a single treatment group and will be treated at a frequency of twice a week for five weeks. In each session, the PNF patterns will be repeated four times, on both sides, stimulating muscle irradiation and evoking the contraction of the tibialis anterior muscle. During the repetition of the patterns, the dorsiflexor muscle response of each patient will be obtained by an electromyography (EMG) surface.
The data of the RMS values obtained in the first session will be normalized and transformed into percentage. The average RMS of each diagonal at the beginning of treatment corresponds to 100% of TA muscle activation. The RMS values obtained in the last session will be normalized as a percentage, taking into account the results of the first evaluation. After normalization, data from the first and last sessions will besubjected to the for paired t-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy group. | Other | Other: Proprioceptive Neuromuscular Facilitation - PNFGroup formed by healthy patients. |
| Group with demyelinating polyneuropathy | Other | Other: Proprioceptive Neuromuscular Facilitation - PNFGroup formed by patients with demyelinating polyneuropathy. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy individuals group: who agree to participate in the study with no history of previous trauma or disease of the shoulder girdle, with absence of clinical signs painful in the shoulder joint.
- Group with demyelinating polyneuropathy: both sexes, carriers of CMT-1A disease with functional changes in the lower limbs with good cognition and difficulty of to ambulate with and without assistance.
Key exclusion criteria (2 listed)
- Healthy individuals group: subject with restricted range of motion, muscle weakness, cognitive impairment, which exhibits a pathology that leads to alterations in muscle recruitment.
- Patients with polyneuropathy: cardiac arrhythmias, uncontrolled hypertension, severe cardiovascular disease and respiratory problems. The use of own medicines to treat pathology was accepted.
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 |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation - PNF | Other | Group with demyelinating polyneuropathy, Healthy group. |
Primary outcome
Evaluation of muscle force irradiation, through surface electromyography.
Time frame: This evaluation of patients is performed in only one day, being made before, during and after the application of the protocols. It is estimated that the results are collected in one years.
Irradiation of muscle strength will be assessed using surface electromyography, which shows the activation or not of the muscles evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Proprioceptive Neuromuscular Facilitation - PNF in people with Assessment of Muscle Force Irradiation, run by University of Sao Paulo at 1 site in Brazil.
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 2 inclusion and 2 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 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ana Cláudia S Ferreira, graduate student (+55-16 988027661 ext. 0740, acsilvaf35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of muscle force irradiation, through surface electromyography. (time frame: This evaluation of patients is performed in only one day, being made before, during and after the application of the protocols. It is estimated that the results are collected in one years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2014.