NCT06937008

Brief Summary

Postmenopausal diabetic women have significant balance deficits and increased fall risk. Whole-body vibration may improve balance in these population but needs further research. The purpose of the current study was to determine the effect of whole-body vibration on balance in postmenopausal diabetic women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
Last Updated

April 20, 2025

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

January 6, 2025

Last Update Submit

April 17, 2025

Conditions

Keywords

balancequality of lifewhole body vibrationdiabetespostmenopausal

Outcome Measures

Primary Outcomes (1)

  • OSI

    TThe BBS measures, in degrees, the tilt about each axis during dynamic conditions and calculates a medial-lateral stability index (MLSI), anterior-posterior stability index (APSI), and an overall stability index (OSI). The OSI score is believed to be the best indicator of the overall ability.

    pre and after 3 months of intervention

Study Arms (2)

WBV group

EXPERIMENTAL

consisted of twenty postmenopausal women with diabetic neuropathy who received whole body vibration and balancing exercise (three times per week for 12 weeks).

Other: Whole body vibrationOther: Balance training

Balance group

ACTIVE COMPARATOR

consisted of twenty postmenopausal women with diabetic neuropathy who received the same balancing exercises as for group A (three times per week for 12 weeks).

Other: Balance training

Interventions

All women in group (A) received whole body vibration and balance board training, three times per week for three months. Parameters: The WBV was performed by using whole body vibration which is a side-alternating vibration device working as a teeterboard with amplitude of 0 to 5.3 mm (medial to distal) and a variable frequency of 5 to 30 Hz. The amplitude was controlled by adjusting the foot position from 1 to 3, with the larger the position, the greater the amplitude. Before the treatment, procedures of using the Galileo 900 were instructed by the research assistant and its safety issues explained. Patient's position: The patient was asked to stand on WBV device by Hold hand support for those elderly women. the vibrating platform in a 100 to 110° squat position, the oscillating platform operating at 20Hz in bare feet at the second foot position for 15 minutes a day for 3 days a week for 3 months. All unusual or uncomfortable complaints from subjects during the WBV treatment were docu

WBV group

Balance training exercises treatment: All women in both group (A, B) received balance training exercises on balance ball, half ball and balance board exercises three times per week for 3 months

Balance groupWBV group

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients were examined by a gynaecologist before the study and were selected according to the following criteria:
  • Diabetic postmenopausal women who suffered from peripheral neuropathy
  • Their ages ranged from 50 to 65 years.
  • Body Mass Indices (BMI) ≤ 30kg/m2
  • They were medically stable.

You may not qualify if:

  • Patients were examined by a gynaecologist before the study and were excluded if they had:
  • Inner ear disturbance.
  • Musculoskeletal problems.
  • Active tuberculosis and tumours.
  • Implanted cardiac rhythm devices.
  • Any hormonal replacement therapy or drug treatment that could affect normal metabolism of musculoskeletal system.
  • Habitual exercise or participate in any supervised exercise.
  • Hypo- or hyperparathyroidism, renal, liver, or chronic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haven Police and El Bagour specialized Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Physical Therapy for Women's Health Faculty of Physical Therapy Cairo University

Study Record Dates

First Submitted

January 6, 2025

First Posted

April 20, 2025

Study Start

May 28, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

April 20, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations