NCT04820738

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

March 26, 2021

Last Update Submit

March 29, 2021

Conditions

Keywords

Postmenopausal, Obese, Balance, Proprioception

Outcome Measures

Primary Outcomes (3)

  • Functional Reach Test (FRT)

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

    2 months

  • 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

    2 months

  • 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

    2 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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).

Other: Sensorimotor training exercises

Control group

ACTIVE COMPARATOR

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

Other: Without Sensorimotor training exercises

Interventions

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

Experimental group

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

Control group

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspost manupausal women obesty BMI More than 30
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binash afzal

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • 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.

    PMID: 32349543BACKGROUND
  • Marsden JF. Cerebellar ataxia. Handb Clin Neurol. 2018;159:261-281. doi: 10.1016/B978-0-444-63916-5.00017-3.

    PMID: 30482319BACKGROUND
  • 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.

    PMID: 26279172BACKGROUND
  • 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.

    PMID: 29193314BACKGROUND
  • 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.

    PMID: 28109566BACKGROUND
  • 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.

    PMID: 2977590BACKGROUND
  • 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.

    PMID: 29061169BACKGROUND
  • 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.

    PMID: 26511625BACKGROUND
  • 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.

    PMID: 29037206BACKGROUND
  • 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.

    PMID: 29236934BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Binash Afzal, PHD*

    Riphah international university lahore campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

March 29, 2021

Study Start

February 15, 2020

Primary Completion

October 20, 2020

Study Completion

December 20, 2020

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations