Balance Disorders WaterNCT04499170

Effect of Muscular Energy Technique on Postural Control

A study testing Muscular Energy Technique G1 and Muscular Energy Technique G2 in people with Balance Disorders Water, run by Universidade Norte do Paraná at 1 site in Brazil.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Balance Disorders Water
What is being tested?: Muscular Energy Technique G1 and Muscular Energy Technique G2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteBrazil
Study dates: Jan 2024to Dec 2024
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 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Accepting to participate in a study on a voluntary basis;
Aged between 18 and 35 years old for young adults and over 60 years old up to 85 years old for elderly people;
Being physically independent;
Not practicing regular physical activity as recommended by the ACSM 3 to 5 times a week with moderate and severe;
Cognitive status> 18 in the Mini-Mental State Examination.

Who cannot join

Elderly with cognitive changes detectable by the Mini Mental State Examination (MMSE);
A score lower than the score predicted for their level of education;
Self-reported injuries;
Falls in the last year;
Musculoskeletal disorders;
Systemic neurological-degenerative disease;
Severe labyrinthitis and chronic diseases of the cardiovascular or respiratory system.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Laboratory of Functional Assessment and Human Motor Performance (LAFUP)
Londrina, Paraná, 86041-120

Other trials in Brazil

About this study

Official title: Immediate Effect of the Muscle Energy Technique on Postural Control in the Elderly and Young Adults

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.

Read the detailed description

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.

Conditions: Balance Disorders Water
Being tested: Muscular Energy Technique G1, Muscular Energy Technique G2
Keywords: Postural Balance, Musculoskeletal Manipulations, physiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Muscular Energy Technique G1Other
Also called "MET"
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.
Muscular Energy Technique G2Other
Also called ''MET''
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.

Study groups in NCT04499170
Study group	Role	What they receive
Muscle energy technique (G1)	Experimental	Group Elderly (G1) Receives: Other: Muscular Energy Technique G1
Muscle energy technique (G2)	Active comparator	Group of young people (G2) Receives: Other: Muscular Energy Technique G2

What is being measured

The primary outcome is the main question the study is designed to answer.

Balance
Balance measured by a Force platform
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2024Dec 2024

First posted5 Aug 2020
Study startJan 2024 (estimated)
Primary completionJul 2024 (estimated)
Study completionDec 2024 (estimated)

Why it stopped: I left Unopar

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Balance Disorders WaterStudies 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: Randomised
Intervention model: Parallel groups
Model description: Quasi-experimental research project to detect an immediate effect of a technique on postural balance measures.
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04499170
Sponsor's protocol ID: PP07009
Status last verified: May 2023
First submitted: 24 Apr 2020
Last updated: 10 May 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

MINATTO et al. Idade, maturação sexual, variáveis antropométricas e composição corporal: influências na flexibilidade. Rev Bras Cineantropom Desempenho Hum. 2010;12(3):151-8.
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.
Horak FB, Henry SM, Shumway-Cook A; New Collective Author. Postural perturbations: new insights for treatment of balance disorders. Phys Ther. 1997 May;77(5):517-33. doi: 10.1093/ptj/77.5.517.
PubMed 9149762
CHAITOW L. Técnicas de energia muscular. São Paulo: Manole; 2001
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.
PubMed 8607762
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.
PubMed 10699556
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.
PubMed 25231775
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.
PubMed 8002795
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.
PubMed 7137077
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.
PubMed 1956274
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.
PubMed 7715058
Adaptação do Habitual Physical Activity Questionnaire (Baecke), versão modificada, para a população portuguesa. Maria Celeste Bastos Almeida; José Luís Pais Ribeiro.
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.
PubMed 20730369
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.
Fitness Canada. Canadian Standardized Test of Fitness (CSTF) Operations Manual. 3rd Ed. Ottawa: Fitness and Amateur Sport, Canada, 1986

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Balanced Crystalloid vs Normal Saline in Pediatric Acute Gastroenteritis
Gastroenteritis Acute, Dehydration
RecruitingPhase 4
CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS
Critical Care, Intensive Care, Fluid Accumulation
RecruitingObservational study
Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial
Non-hypervolemic Hyponatremia
Not yet recruiting
Dynamic Hot Spring Hydrotherapy for Gait Disorders and Balance Function Recovery After Stroke
Stroke
Recruiting
Effects of Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy Children

All Balance Disorders Water trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immediate Effect of the Muscle Energy Technique on Postural Control in the Elderly and Young Adults
ClinicalTrials.gov ID: NCT04499170
Acronym / sponsor ID: PP07009
Conditions: Balance Disorders Water
Keywords: Postural Balance, Musculoskeletal Manipulations, physiotherapy
Study type: Interventional
Recruitment status: WithdrawnReason stopped: I left Unopar
Enrolment: 0 participants (actual)
Lead sponsor: Universidade Norte do ParanáUniversity, hospital or other
Study start: Jan 2024 (estimated)
Primary completion: Jul 2024 (estimated)
Study completion: Dec 2024 (estimated)
First posted: 5 Aug 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Quasi-experimental research project to detect an immediate effect of a technique on postural balance measures.

Arm	Type	Receives
Muscle energy technique (G1)	Experimental	Other: Muscular Energy Technique G1Group Elderly (G1)
Muscle energy technique (G2)	Active comparator	Other: Muscular Energy Technique G2Group of young people (G2)

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Accepting to participate in a study on a voluntary basis;
Aged between 18 and 35 years old for young adults and over 60 years old up to 85 years old for elderly people;
Being physically independent;
Not practicing regular physical activity as recommended by the ACSM 3 to 5 times a week with moderate and severe;
Cognitive status> 18 in the Mini-Mental State Examination.

Key exclusion criteria (7 listed)

Elderly with cognitive changes detectable by the Mini Mental State Examination (MMSE);
A score lower than the score predicted for their level of education;
Self-reported injuries;
Falls in the last year;
Musculoskeletal disorders;

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
Muscular Energy Technique G1Also: "MET"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.	Other	Muscle energy technique (G1)
Muscular Energy Technique G2Also: ''MET''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.	Other	Muscle energy technique (G2)

Primary outcome

Balance
Time frame: Baseline
Balance measured by a Force platform

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
BackgroundMINATTO et al. Idade, maturação sexual, variáveis antropométricas e composição corporal: influências na flexibilidade. Rev Bras Cineantropom Desempenho Hum. 2010;12(3):151-8.
BackgroundFRYER 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.
Background: PubMed 9149762Horak FB, Henry SM, Shumway-Cook A; New Collective Author. Postural perturbations: new insights for treatment of balance disorders. Phys Ther. 1997 May;77(5):517-33. doi: 10.1093/ptj/77.5.517.
BackgroundCHAITOW L. Técnicas de energia muscular. São Paulo: Manole; 2001
Background: PubMed 8607762Magnusson 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.
Background: PubMed 10699556Lariviere 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.
Background: PubMed 25231775Shultz 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.
Background: PubMed 8002795Bertolucci 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.
Background: PubMed 7137077Baecke 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.
Background: PubMed 1956274Voorrips 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.
Background: PubMed 7715058Province 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.
BackgroundAdaptação do Habitual Physical Activity Questionnaire (Baecke), versão modificada, para a população portuguesa. Maria Celeste Bastos Almeida; José Luís Pais Ribeiro.

Related trials for Balance Disorders Water

RecruitingObservational study
Balanced Crystalloid vs Normal Saline in Pediatric Acute Gastroenteritis
Gastroenteritis Acute, Dehydration
RecruitingPhase 4
CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS
Critical Care, Intensive Care, Fluid Accumulation
RecruitingObservational study
Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial
Non-hypervolemic Hyponatremia
Not yet recruiting
Dynamic Hot Spring Hydrotherapy for Gait Disorders and Balance Function Recovery After Stroke
Stroke
Recruiting
Effects of Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy Children

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Muscular Energy Technique G1 and Muscular Energy Technique G2 in people with Balance Disorders Water, run by Universidade Norte do Paraná 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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 10 May 2023. 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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Balance (time frame: Baseline). 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 NCT04499170, which also lists 16 linked publications.

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 10 May 2023.