NCT05281289

Brief Summary

The aim of this study is to investigate the effect of kinesio-tape application and stretching exercise on calf muscle cramp during pregnancy

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

March 20, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

March 7, 2022

Last Update Submit

March 7, 2022

Conditions

Keywords

kinesio-tape,stretching exercises, calf cramps, pregnants, cramp questionnaire

Outcome Measures

Primary Outcomes (1)

  • calf pain intensity

    cramp VAS is used to measure pain intensity

    2days

Secondary Outcomes (2)

  • weight bearing ankle dorsiflexion ROM

    2days

  • straight leg raising ROM

    2days

Study Arms (2)

Kinesio-tape application+stretchinge exercises

EXPERIMENTAL

the patient received A"Ystrip"of KT was applied to the testing leg 30% tension for 48h and was asked to assume comfortable supine position and the therapist applied 15 seconds of passive stretch to the calf muscle followed by 30 seconds of rest and this exercise was repeated 6 times per session for 2 days and ecieved instructions about dealing with calf cramps with self low sustained stretch of calf muscle.

Other: kinesio-tapeOther: stretching exerciseOther: instructions about dealing with calf cramps

self low sustained strestch

EXPERIMENTAL

the patient recieved instructions about dealing with calf cramps with self low sustained stretch of calf muscle.

Other: instructions about dealing with calf cramps

Interventions

KT is comprised of a polymer elastic strand warped by 100% cotton fibers and designed to allow a longitudinal stretch of 55-60% of its resting length.

Kinesio-tape application+stretchinge exercises

15 seconds of passive stretching exercise for calf muscle followed by 30 seconds of rest

Kinesio-tape application+stretchinge exercises

instructions about dealing with calf cramps by self low sustained stretch of calf muscle

Kinesio-tape application+stretchinge exercisesself low sustained strestch

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women who are suffering from calf cramps.
  • Their age range from 25 to 35 years.
  • Their body mass index range from 25 to 29.9 kg/m2 .

You may not qualify if:

  • Skin abnormalities (skin malignancy in the treated area or burned).
  • History of previous back surgery.
  • Neuromuscular diseases like multiple sclerosis.
  • Sensory disturbances.
  • Evidence of previous vertebral fractures or major spinal structural abnormality, spondylolisthesis or spinal stenosis.
  • Systemic disease of musculoskeletal system.
  • Viscerogenic cause of back pain.
  • Also, women who have eclampsia or pre-eclampsia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11311, Egypt

Location

MeSH Terms

Interventions

Athletic TapeMuscle Stretching Exercises

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical EquipmentExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 16, 2022

Study Start

March 20, 2021

Primary Completion

November 30, 2021

Study Completion

April 1, 2022

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations