NCT06354803

Brief Summary

The effect of kinaesthetic training on performance and postural stability during pregnancy and 2 weeks postpartum

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_2

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

March 2, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

March 12, 2024

Last Update Submit

April 4, 2024

Conditions

Postural Stability

Keywords

Kinaesthetic training

Outcome Measures

Primary Outcomes (1)

  • change of postural stability

    By the use of balance check board 636-1 the balance of pregnant women changed significantly which appears in change in the rate of falling

    1 month

Study Arms (2)

intervention group

EXPERIMENTAL

23 women below 28 week gestation were received kinaesthetic exercises on the Pezzi ball and standard antenatal care

Other: proprioceptive training

control group

NO INTERVENTION

22 women belowe 28 week gestation were received just standard antenatal care

Interventions

proprioceptive trainingOTHER

Proprioceptive training using swiss ball for 12 sessions

Also known as: Standard antenatal care
intervention group

Eligibility Criteria

Age25 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnanc women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 25 and 30 years a body mass index (BMI) not exceeding 32 kg/m2, low-risk gestation primiparous pregnancy intact sensory motor integration in the lower extremities.

You may not qualify if:

  • more than 28 weeks gestation
  • had chronic disease
  • multiparous

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy kafrelshiekh university

Kafr ash Shaykh, Kafrelshiekh, 6850001, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The drawing procedure was conducted by a researcher without disclosure to the participants, ensuring unbiased allocation. Moreover, both the assessor and statistician remained blinded throughout the assessment period, unaware of the group assignments.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 45 participants with gestational age below 28 weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 12, 2024

First Posted

April 9, 2024

Study Start

March 2, 2023

Primary Completion

February 2, 2024

Study Completion

March 3, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations

EG(1)