<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04499170</url>
  </required_header>
  <id_info>
    <org_study_id>PP07009</org_study_id>
    <nct_id>NCT04499170</nct_id>
  </id_info>
  <brief_title>Effect of Muscular Energy Technique on Postural Control</brief_title>
  <official_title>Immediate Effect of the Muscle Energy Technique on Postural Control in the Elderly and Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Norte do Paraná</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Norte do Paraná</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The research aims to evaluate the immediate effect of the muscle energy technique (TEM) on&#xD;
      postural control responses in the elderly and young adults. The sample will be selected for&#xD;
      convenience, being participants of both sexes, young and old. Evaluation of postural control&#xD;
      through the force platform will be performed during the unipodal and semi-tandem balance&#xD;
      tests. The main parameters of postural control will be calculated using the pressure center&#xD;
      derivative. After the balance tests, the participants will be submitted to TEM and&#xD;
      immediately afterwards reassessed on the force platform.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aging is considered a dynamic and progressive process, in which morphological, functional and&#xD;
      biochemical changes occur. One of the factors associated with old age is the decrease in the&#xD;
      ability to balance posture and the high risk of falls. The literature brings the benefits of&#xD;
      physical exercise in improving balance and preventing falls. However, few studies point to&#xD;
      the benefits of flexibility techniques and their relationship with balance. The objective of&#xD;
      this research is to evaluate the immediate effect of the muscle energy technique (TEM) on&#xD;
      postural control responses in the elderly and young adults. The sample will be selected for&#xD;
      convenience, with 50 participants of both sexes, young people between 18 and 35 years old and&#xD;
      elderly people between 60 and 85 years old. Evaluation of postural control will be performed&#xD;
      through the force platform during the unipodal and semi-tandem balance tests (2 repetitions&#xD;
      of 30 seconds each, with rest of 30 seconds between them). The main parameters of postural&#xD;
      control will be calculated using the pressure center derivative. After the balance tests, the&#xD;
      participants will be submitted to TEM and immediately afterwards reassessed on the force&#xD;
      platform. An analysis of variance will be used to compare the effects between groups (young&#xD;
      versus elderly) and intervention (pre- and post-TEM) and the effects of interaction on the&#xD;
      main variables of postural control. A beneficial effect of TEM is expected, especially in the&#xD;
      elderly group. The results found in this study will contribute to the use of TEM and the&#xD;
      increase of relevant clinical information to benefit the ability to balance in the elderly,&#xD;
      in order to reduce the risk of falls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    I left Unopar&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2024</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Quasi-experimental research project to detect an immediate effect of a technique on postural balance measures.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Balance</measure>
    <time_frame>Baseline</time_frame>
    <description>Balance measured by a Force platform</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Balance Disorders Water</condition>
  <arm_group>
    <arm_group_label>Muscle energy technique (G1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group Elderly (G1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Muscle energy technique (G2)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group of young people (G2)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Muscular Energy Technique G1</intervention_name>
    <description>Group of older (G1) - The muscular energy technique (TEM) based on Chaitow's proposal will be applied to the postural posterior muscles of the lower limbs such as gastrocnemius, soleus, ischiostibials, gluteus medius and paravertebral. During TEM, the contraction will be maintained from 7 to 10 seconds, against the resistance imposed by the therapist. After relaxation, range of motion will be gained until your new restriction barrier. This process will be repeated for 3 times.</description>
    <arm_group_label>Muscle energy technique (G1)</arm_group_label>
    <other_name>&quot;MET&quot;</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Muscular Energy Technique G2</intervention_name>
    <description>Group of young people (G2) - The muscular energy technique (TEM) based on Chaitow's proposal will be applied to the postural posterior muscles of the lower limbs such as gastrocnemius, soleus, ischiostibials, gluteus medius and paravertebral. During TEM, the contraction will be maintained from 7 to 10 seconds, against the resistance imposed by the therapist. After relaxation, range of motion will be gained until your new restriction barrier. This process will be repeated for 3 times.</description>
    <arm_group_label>Muscle energy technique (G2)</arm_group_label>
    <other_name>''MET''</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Accepting to participate in a study on a voluntary basis;&#xD;
&#xD;
          -  Aged between 18 and 35 years old for young adults and over 60 years old up to 85 years&#xD;
             old for elderly people;&#xD;
&#xD;
          -  Being physically independent;&#xD;
&#xD;
          -  Not practicing regular physical activity as recommended by the ACSM 3 to 5 times a&#xD;
             week with moderate and severe;&#xD;
&#xD;
          -  Cognitive status&gt; 18 in the Mini-Mental State Examination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Elderly with cognitive changes detectable by the Mini Mental State Examination (MMSE);&#xD;
&#xD;
          -  A score lower than the score predicted for their level of education;&#xD;
&#xD;
          -  Self-reported injuries;&#xD;
&#xD;
          -  Falls in the last year;&#xD;
&#xD;
          -  Musculoskeletal disorders;&#xD;
&#xD;
          -  Systemic neurological-degenerative disease;&#xD;
&#xD;
          -  Severe labyrinthitis and chronic diseases of the cardiovascular or respiratory system.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Laboratory of Functional Assessment and Human Motor Performance (LAFUP)</name>
      <address>
        <city>Londrina</city>
        <state>Parana</state>
        <zip>86041-120</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>MINATTO et al. Idade, maturação sexual, variáveis antropométricas e composição corporal: influências na flexibilidade. Rev Bras Cineantropom Desempenho Hum. 2010;12(3):151-8.</citation>
  </reference>
  <reference>
    <citation>FRYER G, FOSSUMC. Therapeutic mechanisms underlying muscle energy approaches. In: Fernandez-de-las-Penas C, Arendt-Nielsen Lars, Gerwin R D editor(s). Tension-Type and Cervicogenic Headache: Pathophysiology, Diagnosis, and Management. Sudbury, MA: Jones and Bartlett Publishers,2010.</citation>
  </reference>
  <reference>
    <citation>Horak FB, Henry SM, Shumway-Cook A. Postural perturbations: new insights for treatment of balance disorders. Phys Ther. 1997 May;77(5):517-33. doi: 10.1093/ptj/77.5.517.</citation>
    <PMID>9149762</PMID>
  </reference>
  <reference>
    <citation>CHAITOW L. Técnicas de energia muscular. São Paulo: Manole; 2001</citation>
  </reference>
  <reference>
    <citation>Magnusson SP, Simonsen EB, Aagaard P, Dyhre-Poulsen P, McHugh MP, Kjaer M. Mechanical and physical responses to stretching with and without preisometric contraction in human skeletal muscle. Arch Phys Med Rehabil. 1996 Apr;77(4):373-8. doi: 10.1016/s0003-9993(96)90087-8.</citation>
    <PMID>8607762</PMID>
  </reference>
  <reference>
    <citation>Lariviere C, Gagnon D, Loisel P. The comparison of trunk muscles EMG activation between subjects with and without chronic low back pain during flexion-extension and lateral bending tasks. J Electromyogr Kinesiol. 2000 Apr;10(2):79-91. doi: 10.1016/s1050-6411(99)00027-9.</citation>
    <PMID>10699556</PMID>
  </reference>
  <reference>
    <citation>Shultz S, Averell K, Eickelman A, Sanker H, Donaldson MB. Diagnostic accuracy of self-report and subjective history in the diagnosis of low back pain with non-specific lower extremity symptoms: A systematic review. Man Ther. 2015 Feb;20(1):18-27. doi: 10.1016/j.math.2014.08.002. Epub 2014 Aug 29.</citation>
    <PMID>25231775</PMID>
  </reference>
  <reference>
    <citation>Bertolucci PH, Brucki SM, Campacci SR, Juliano Y. [The Mini-Mental State Examination in a general population: impact of educational status]. Arq Neuropsiquiatr. 1994 Mar;52(1):1-7. Portuguese.</citation>
    <PMID>8002795</PMID>
  </reference>
  <reference>
    <citation>Baecke JA, Burema J, Frijters JE. A short questionnaire for the measurement of habitual physical activity in epidemiological studies. Am J Clin Nutr. 1982 Nov;36(5):936-42. doi: 10.1093/ajcn/36.5.936.</citation>
    <PMID>7137077</PMID>
  </reference>
  <reference>
    <citation>Voorrips LE, Ravelli AC, Dongelmans PC, Deurenberg P, Van Staveren WA. A physical activity questionnaire for the elderly. Med Sci Sports Exerc. 1991 Aug;23(8):974-9.</citation>
    <PMID>1956274</PMID>
  </reference>
  <reference>
    <citation>Province MA, Hadley EC, Hornbrook MC, Lipsitz LA, Miller JP, Mulrow CD, Ory MG, Sattin RW, Tinetti ME, Wolf SL. The effects of exercise on falls in elderly patients. A preplanned meta-analysis of the FICSIT Trials. Frailty and Injuries: Cooperative Studies of Intervention Techniques. JAMA. 1995 May 3;273(17):1341-7.</citation>
    <PMID>7715058</PMID>
  </reference>
  <reference>
    <citation>Adaptação do Habitual Physical Activity Questionnaire (Baecke), versão modificada, para a população portuguesa. Maria Celeste Bastos Almeida; José Luís Pais Ribeiro.</citation>
  </reference>
  <reference>
    <citation>Camargos FF, Dias RC, Dias JM, Freire MT. Cross-cultural adaptation and evaluation of the psychometric properties of the Falls Efficacy Scale-International Among Elderly Brazilians (FES-I-BRAZIL). Rev Bras Fisioter. 2010 May-Jun;14(3):237-43. English, Portuguese.</citation>
    <PMID>20730369</PMID>
  </reference>
  <reference>
    <citation>Wells KF, Dillon EK. The sit and reach: a test of back and leg flexibility. Research Quarterly for Exercise and Sport, Washington, 1952, 23:115-118.</citation>
  </reference>
  <reference>
    <citation>Fitness Canada. Canadian Standardized Test of Fitness (CSTF) Operations Manual. 3rd Ed. Ottawa: Fitness and Amateur Sport, Canada, 1986</citation>
  </reference>
  <reference>
    <citation>Podsiadlo D, Richardson S. The timed &quot;Up &amp; Go&quot;: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.</citation>
    <PMID>1991946</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>April 24, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postural Balance</keyword>
  <keyword>Musculoskeletal Manipulations</keyword>
  <keyword>physiotherapy</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04499170
org study id: PP07009
nct id: NCT04499170
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The research aims to evaluate the immediate effect of the muscle energy technique (TEM) on
      postural control responses in the elderly and young adults. The sample will be selected for
      convenience, being participants of both sexes, young and old. Evaluation of postural control
      through the force platform will be performed during the unipodal and semi-tandem balance
      tests. The main parameters of postural control will be calculated using the pressure center
      derivative. After the balance tests, the participants will be submitted to TEM and
      immediately afterwards reassessed on the force platform.
Aging is considered a dynamic and progressive process, in which morphological, functional and
      biochemical changes occur. One of the factors associated with old age is the decrease in the
      ability to balance posture and the high risk of falls. The literature brings the benefits of
      physical exercise in improving balance and preventing falls. However, few studies point to
      the benefits of flexibility techniques and their relationship with balance. The objective of
      this research is to evaluate the immediate effect of the muscle energy technique (TEM) on
      postural control responses in the elderly and young adults. The sample will be selected for
      convenience, with 50 participants of both sexes, young people between 18 and 35 years old and
      elderly people between 60 and 85 years old. Evaluation of postural control will be performed
      through the force platform during the unipodal and semi-tandem balance tests (2 repetitions
      of 30 seconds each, with rest of 30 seconds between them). The main parameters of postural
      control will be calculated using the pressure center derivative. After the balance tests, the
      participants will be submitted to TEM and immediately afterwards reassessed on the force
      platform. An analysis of variance will be used to compare the effects between groups (young
      versus elderly) and intervention (pre- and post-TEM) and the effects of interaction on the
      main variables of postural control. A beneficial effect of TEM is expected, especially in the
      elderly group. The results found in this study will contribute to the use of TEM and the
      increase of relevant clinical information to benefit the ability to balance in the elderly,
      in order to reduce the risk of falls.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Quasi-experimental research project to detect an immediate effect of a technique on postural balance measures.
primary purpose: Treatment
masking: None (Open Label)
measure: Balance
time frame: Baseline
description: Balance measured by a Force platform
arm group label: Muscle energy technique (G1)
arm group type: Experimental
description: Group Elderly (G1)
arm group label: Muscle energy technique (G2)
arm group type: Active Comparator
description: Group of young people (G2)
intervention type: Other
intervention name: Muscular Energy Technique G1
description: Group of older (G1) - The muscular energy technique (TEM) based on Chaitow's proposal will be applied to the postural posterior muscles of the lower limbs such as gastrocnemius, soleus, ischiostibials, gluteus medius and paravertebral. During TEM, the contraction will be maintained from 7 to 10 seconds, against the resistance imposed by the therapist. After relaxation, range of motion will be gained until your new restriction barrier. This process will be repeated for 3 times.
arm group label: Muscle energy technique (G1)
other name: "MET"
intervention type: Other
intervention name: Muscular Energy Technique G2
description: Group of young people (G2) - The muscular energy technique (TEM) based on Chaitow's proposal will be applied to the postural posterior muscles of the lower limbs such as gastrocnemius, soleus, ischiostibials, gluteus medius and paravertebral. During TEM, the contraction will be maintained from 7 to 10 seconds, against the resistance imposed by the therapist. After relaxation, range of motion will be gained until your new restriction barrier. This process will be repeated for 3 times.
arm group label: Muscle energy technique (G2)
other name: ''MET''
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
citation: MINATTO et al. Idade, maturação sexual, variáveis antropométricas e composição corporal: influências na flexibilidade. Rev Bras Cineantropom Desempenho Hum. 2010;12(3):151-8.
citation: FRYER G, FOSSUMC. Therapeutic mechanisms underlying muscle energy approaches. In: Fernandez-de-las-Penas C, Arendt-Nielsen Lars, Gerwin R D editor(s). Tension-Type and Cervicogenic Headache: Pathophysiology, Diagnosis, and Management. Sudbury, MA: Jones and Bartlett Publishers,2010.
citation: Horak FB, Henry SM, Shumway-Cook A. Postural perturbations: new insights for treatment of balance disorders. Phys Ther. 1997 May;77(5):517-33. doi: 10.1093/ptj/77.5.517.
PMID: 9149762
citation: CHAITOW L. Técnicas de energia muscular. São Paulo: Manole; 2001
citation: Magnusson SP, Simonsen EB, Aagaard P, Dyhre-Poulsen P, McHugh MP, Kjaer M. Mechanical and physical responses to stretching with and without preisometric contraction in human skeletal muscle. Arch Phys Med Rehabil. 1996 Apr;77(4):373-8. doi: 10.1016/s0003-9993(96)90087-8.
PMID: 8607762
citation: Lariviere C, Gagnon D, Loisel P. The comparison of trunk muscles EMG activation between subjects with and without chronic low back pain during flexion-extension and lateral bending tasks. J Electromyogr Kinesiol. 2000 Apr;10(2):79-91. doi: 10.1016/s1050-6411(99)00027-9.
PMID: 10699556
citation: Shultz S, Averell K, Eickelman A, Sanker H, Donaldson MB. Diagnostic accuracy of self-report and subjective history in the diagnosis of low back pain with non-specific lower extremity symptoms: A systematic review. Man Ther. 2015 Feb;20(1):18-27. doi: 10.1016/j.math.2014.08.002. Epub 2014 Aug 29.
PMID: 25231775
citation: Bertolucci PH, Brucki SM, Campacci SR, Juliano Y. [The Mini-Mental State Examination in a general population: impact of educational status]. Arq Neuropsiquiatr. 1994 Mar;52(1):1-7. Portuguese.
PMID: 8002795
citation: Baecke JA, Burema J, Frijters JE. A short questionnaire for the measurement of habitual physical activity in epidemiological studies. Am J Clin Nutr. 1982 Nov;36(5):936-42. doi: 10.1093/ajcn/36.5.936.
PMID: 7137077
citation: Voorrips LE, Ravelli AC, Dongelmans PC, Deurenberg P, Van Staveren WA. A physical activity questionnaire for the elderly. Med Sci Sports Exerc. 1991 Aug;23(8):974-9.
PMID: 1956274
citation: Province MA, Hadley EC, Hornbrook MC, Lipsitz LA, Miller JP, Mulrow CD, Ory MG, Sattin RW, Tinetti ME, Wolf SL. The effects of exercise on falls in elderly patients. A preplanned meta-analysis of the FICSIT Trials. Frailty and Injuries: Cooperative Studies of Intervention Techniques. JAMA. 1995 May 3;273(17):1341-7.
PMID: 7715058
citation: Adaptação do Habitual Physical Activity Questionnaire (Baecke), versão modificada, para a população portuguesa. Maria Celeste Bastos Almeida; José Luís Pais Ribeiro.
citation: Camargos FF, Dias RC, Dias JM, Freire MT. Cross-cultural adaptation and evaluation of the psychometric properties of the Falls Efficacy Scale-International Among Elderly Brazilians (FES-I-BRAZIL). Rev Bras Fisioter. 2010 May-Jun;14(3):237-43. English, Portuguese.
PMID: 20730369
citation: Wells KF, Dillon EK. The sit and reach: a test of back and leg flexibility. Research Quarterly for Exercise and Sport, Washington, 1952, 23:115-118.
citation: Fitness Canada. Canadian Standardized Test of Fitness (CSTF) Operations Manual. 3rd Ed. Ottawa: Fitness and Amateur Sport, Canada, 1986
citation: Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
PMID: 1991946
responsible party type: Sponsor