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.
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.
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.
- Conditions
- Post Menopaused Female
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Other: Without Sensorimotor training exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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.
- First posted29 Mar 2021
- Study start15 Feb 2020
- Primary completion20 Oct 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Post Menopaused FemaleStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binash Afzal, PHD*, Principal investigator, Riphah international university lahore campus
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 32349543Marsden JF. Cerebellar ataxia. Handb Clin Neurol. 2018;159:261-281. doi: 10.1016/B978-0-444-63916-5.00017-3.
PubMed 30482319Yang 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 26279172Silva 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 29193314Ravi 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 28109566Skards 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 2977590Geiger 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 29061169Martins 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 26511625Pellegrino 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 29037206Gomiero 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sensory Motor Training on Balance and Proprioception Among Post-Menopausal Obese Women
- ClinicalTrials.gov ID
- NCT04820738
- Acronym / sponsor ID
- REC/Lhr/20/2050 Sehar Shabeer
- Conditions
- Post Menopaused Female
- Keywords
- Postmenopausal, Obese, Balance, Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 29 Mar 2021 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Sensorimotor training exercisesSensorimotor 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). |
| Control group | Active comparator | Other: Without Sensorimotor training exercisesCut 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 |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Post-menopausal obese women
Key exclusion criteria (7 listed)
- • History of ankle sprain
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 |
|---|---|---|
| Sensorimotor training exercisesSensorimotor 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 | Experimental group |
| Without Sensorimotor training exercisesCut 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 | Control group |
Primary outcome
Functional Reach Test (FRT)
Time frame: 2 months
Functional Reach Test (FRT) is a clinical outcome measure used to asses dynamic balance in one simple task.
Time Up and Go Test (TUG)
Time frame: 2 months
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
One Leg Stance Test (OLS)
Time frame: 2 months
The Single leg Stance (SLS) Test is used to evaluate static postural and balance control with one eye open and standing on one leg
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Background: PubMed 32349543Cabrera-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.
- Background: PubMed 30482319Marsden JF. Cerebellar ataxia. Handb Clin Neurol. 2018;159:261-281. doi: 10.1016/B978-0-444-63916-5.00017-3.
- Background: PubMed 26279172Yang 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.
- Background: PubMed 29193314Silva 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.
- Background: PubMed 28109566Ravi 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.
- Background: PubMed 2977590Skards 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.
- Background: PubMed 29061169Geiger 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.
- Background: PubMed 26511625Martins 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.
- Background: PubMed 29037206Pellegrino 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.
- Background: PubMed 29236934Gomiero 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.
- Individual participant dataSharing planned: No
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.
Binash Afzal, PHD* principal investigator
Riphah international university lahore campus
1 site in 1 country: see every site and its status.
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.