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Post Menopaused FemaleNCT04820738

Effects of Sensory Motor Training on Balance and Proprioception Among Post-Menopausal Obese Women

A study testing Sensorimotor training exercises and Without Sensorimotor training exercises in people with Post Menopaused Female, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Postmenopausal obese women often have difficulties with balance and proprioception. Sensorimotor training is an important part of physical therapy interventions, with emerging evidence that it could be beneficial for postmenopausal obese women. Read more about this study

Who is it for?
Ages 45 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Post Menopaused Female
What is being tested?
Sensorimotor training exercises and Without Sensorimotor training exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 sitePakistan
Study dates
15 Feb 2020to 20 Dec 2020
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 45 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • • Post-menopausal obese women
  • BMI ≥30
  • Participants independent in ADLs
  • self-ambulatory
  • healthy (having no known condition in which sensorimotor exercises would be contraindicated.)

Who cannot join

  • • History of ankle sprain
  • Uncontrolled diabetes mullites
  • Presence of orthopaedic problems.
  • Neurological disorders.
  • Psychological problems.
  • Cognitive issues.
  • People with severe visual issues

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Binash afzal

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Postmenopausal obese women often have difficulties with balance and proprioception. Sensorimotor training is an important part of physical therapy interventions, with emerging evidence that it could be beneficial for postmenopausal obese women.

Objective: To find the impact of sensorimotor training on balance and proprioception among postmenopausal obese women.

Read the detailed description

Randomized clinical trial was conducted on postmenopausal obese women population with impaired balance and proprioception on inclusion \& exclusion criteria, sample size of 40, ages ranged from 45 to 65 years included. Group A received SMT and Group B received CT. The interval of treatment was 6 weeks. Data is collected from THQ Samundri. FRT, TUG, OLS utilized to assess the pre-and post-estimations of postural strength.

Being tested
Sensorimotor training exercises, Without Sensorimotor training exercises
Keywords
Postmenopausal, Obese, Balance, Proprioception
Medical subject headings
Obesity

What participants receive

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

  • Sensorimotor training exercisesOther

    Sensorimotor training exercises include wall slides , core exercises (Planks, leg raises, crunches, bridging) balance exercises (single leg side lift, leg lift with dumble, balance on stability ball) on unstable surface for 50-60 min (3 sets of 10 rep) of exercises and gait training (different patterns of walking

  • Without Sensorimotor training exercisesOther

    Cut back on high-fat foods. Drink plenty of water Use sugar and salt in moderation. Eat fruits and vegetables Get enough calcium Pump up your iron. Get enough fiber

Study groups in NCT04820738
Study groupRoleWhat they receive
Experimental groupExperimentalSensorimotor training exercises include wall slides , core exercises (Planks, leg raises, crunches, bridging) balance exercises (single leg side lift, leg lift with dumble, balance on stability ball) on unstable surface for 50-60 min (3 sets of 10 rep) of exercises and gait training (different patterns of walking).
Receives: Other: Sensorimotor training exercises
Control groupActive comparatorCut back on high-fat foods. Drink plenty of water Use sugar and salt in moderation. Eat fruits and vegetables Get enough calcium Pump up your iron. Get enough fiber
Receives: Other: Without Sensorimotor training exercises

What is being measured

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

  1. Functional Reach Test (FRT)

    Functional Reach Test (FRT) is a clinical outcome measure used to asses dynamic balance in one simple task.

    Measured: 2 months

  2. Time Up and Go Test (TUG)

    Time Up and Go test is used to assess the individual's mobility, static and dynamic balance walking ability and risk of fall among older adults. Intratester and intertester reliability (ICC) in elderly populations

    Measured: 2 months

  3. One Leg Stance Test (OLS)

    The Single leg Stance (SLS) Test is used to evaluate static postural and balance control with one eye open and standing on one leg

    Measured: 2 months

Timeline

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

  1. First posted29 Mar 2021
  2. Study start15 Feb 2020
  3. Primary completion20 Oct 2020
  4. Study completion20 Dec 2020

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04820738
Sponsor's protocol ID
REC/Lhr/20/2050 Sehar Shabeer
Status last verified
Mar 2021
First submitted
26 Mar 2021
Last updated
30 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cabrera-Martos I, Jimenez-Martin AT, Lopez-Lopez L, Rodriguez-Torres J, Ortiz-Rubio A, Valenza MC. Effects of a core stabilization training program on balance ability in persons with Parkinson's disease: a randomized controlled trial. Clin Rehabil. 2020 Jun;34(6):764-772. doi: 10.1177/0269215520918631. Epub 2020 Apr 29.

    PubMed 32349543

  • Marsden JF. Cerebellar ataxia. Handb Clin Neurol. 2018;159:261-281. doi: 10.1016/B978-0-444-63916-5.00017-3.

    PubMed 30482319

  • Yang WC, Wang HK, Wu RM, Lo CS, Lin KH. Home-based virtual reality balance training and conventional balance training in Parkinson's disease: A randomized controlled trial. J Formos Med Assoc. 2016 Sep;115(9):734-43. doi: 10.1016/j.jfma.2015.07.012. Epub 2015 Aug 13.

    PubMed 26279172

  • Silva PB, Oliveira AS, Mrachacz-Kersting N, Kersting UG. Effects of wobble board training on single-leg landing neuromechanics. Scand J Med Sci Sports. 2018 Mar;28(3):972-982. doi: 10.1111/sms.13027. Epub 2018 Jan 30.

    PubMed 29193314

  • Ravi DK, Kumar N, Singhi P. Effectiveness of virtual reality rehabilitation for children and adolescents with cerebral palsy: an updated evidence-based systematic review. Physiotherapy. 2017 Sep;103(3):245-258. doi: 10.1016/j.physio.2016.08.004. Epub 2016 Sep 27.

    PubMed 28109566

  • Skards IaV, Vitols AV, Matisone DR, Dzerve-Talums VIa, Skarda IIa. [Correlation of functional and structural changes of the cardiovascular system in hypertensive disease]. Fiziol Zh SSSR Im I M Sechenova. 1988 Nov;74(11):1628-35. Russian.

    PubMed 2977590

  • Geiger M, Supiot A, Zory R, Aegerter P, Pradon D, Roche N. The effect of transcranial direct current stimulation (tDCS) on locomotion and balance in patients with chronic stroke: study protocol for a randomised controlled trial. Trials. 2017 Oct 23;18(1):492. doi: 10.1186/s13063-017-2219-6.

    PubMed 29061169

  • Martins E Silva DC, Bastos VH, de Oliveira Sanchez M, Nunes MK, Orsini M, Ribeiro P, Velasques B, Teixeira SS. Effects of vestibular rehabilitation in the elderly: a systematic review. Aging Clin Exp Res. 2016 Aug;28(4):599-606. doi: 10.1007/s40520-015-0479-0. Epub 2015 Oct 28.

    PubMed 26511625

  • Pellegrino L, Giannoni P, Marinelli L, Casadio M. Effects of continuous visual feedback during sitting balance training in chronic stroke survivors. J Neuroeng Rehabil. 2017 Oct 16;14(1):107. doi: 10.1186/s12984-017-0316-0.

    PubMed 29037206

  • Gomiero AB, Kayo A, Abraao M, Peccin MS, Grande AJ, Trevisani VF. Sensory-motor training versus resistance training among patients with knee osteoarthritis: randomized single-blind controlled trial. Sao Paulo Med J. 2018 Jan-Feb;136(1):44-50. doi: 10.1590/1516-3180.2017.0174100917. Epub 2017 Dec 7.

    PubMed 29236934

Questions about this trial

What is this clinical trial studying?

A study testing Sensorimotor training exercises and Without Sensorimotor training exercises in people with Post Menopaused Female, run by Riphah International University at 1 site in Pakistan.

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: finished, as of the sponsor's last update on 30 Mar 2021. 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 Pakistan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Functional Reach Test (FRT) (time frame: 2 months). The study lists 3 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 NCT04820738, which also lists 10 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 30 Mar 2021.

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