NCT06198192

Brief Summary

This study will determine the effects of Pilates exercises on static and dynamic balance in children with hearing impairment. Children with hearing impairment often encounter challenges in their motor development, including difficulties in maintaining balance and mobility. Impaired balance and limited mobility can significantly impact their overall physical well-being and functional independence. Therefore, it becomes crucial to explore effective interventions that can address these specific needs and promote improve balance and mobility in this population. Pilates, a mind-body exercise approach, has gained recognition for its potential benefits in enhancing balance, flexibility, and core strength in various populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

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

December 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

December 26, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

BalanceHearing ImpairmentPilate exercises

Outcome Measures

Primary Outcomes (3)

  • Pediatric Balance Scale

    It is 14-item criterion-referenced measure that examines functional balance in the context of everyday tasks in the pediatric population in 3 domains sitting, standing and changing of position. It measures steady state and anticipatory balance activities of varying difficulty that will be performed with or without visual inputs. Item score from 0-4 which may be measured by the ability to perform the assessed activity. Item scores will be summed having maximum score of 56 points that indicate perfect score. Time of administration is 20 minutes. It has excellent test retest reliability in typically developmental child that is (ICC 0.850)

    10 weeks

  • Pediatric Reach Test (Pediatric Functional Reach Test):

    It is used to measure standing balance in pediatric population, it is only done in standing position. The standing position will be described first and target will be set under the supervision first forward reach will be tested and after this lateral reach will be tested. Reliability of this test is within rater (0.54, 0.88 ICC) and among the rater is (0.50, 0.93ICC)

    10 weeks

  • Time Up and Go Test (TUG)

    It provides valuable measures how quickly one can stand up, walk 10 feet, turn around, walk back and sit down. Patient sit in the chair on the command go patient rises from the chair walks 3 meters at comfortable and safe pace, turns, walk back to the chair and sits down. Timings begins with the instruction go and end when the patient is seated. Reliability of TUG test was high, with ICC of 0.99 for within-session reliability and 0.99 for test-retest reliability analyzes on CP children

    10 weeks

Study Arms (2)

Balance Exercises

ACTIVE COMPARATOR

This group will receive conventional exercises for balance.

Other: Conventional Therapy and Balance Exercises

Pilates Exercises

EXPERIMENTAL

This group will receive Pilate exercises along with Balance exercises

Other: Pilates Exercises

Interventions

Ten repetitions of Pilates exercises will be performed with a 2-minute rest period between repetitions. Pilate group will receive the intervention program three times/week for total 10 weeks

Pilates Exercises

this group receive conventional therapy along with balance exercises. Standing with feet together while the therapist sitting behind and manually locking the child knees, and then slowly tilt him to each side, forward and backward. Step standing with therapist behind the child guiding him to shift his weight forward then backward alternately. High step standing and try to keep balanced. Standing with manual locking of the knees then tries actively to stoop and recover. Equilibrium, righting and protective reactions training. Open environment gait training will be conducted with the different obstacles. Session includes three times/week for total 10 weeks

Balance Exercises

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 5 to10 years
  • Having greater than 24 score of mini mental state examination (MMSE-C) for children
  • Children diagnosed with congenital sensorIneural hearing impairment
  • Having a hearing loss\>75dB
  • Able to follow instructions

You may not qualify if:

  • Presence of any visual, physical or mental disability in addition to hearing loss, or any orthopedic or neurological problem that may affect balance
  • Severe hearing losses were greater than75dB
  • Parents or patient refuse to take part
  • Have participated in other therapy programs during our intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

  • Rajendran V, Roy FG. An overview of motor skill performance and balance in hearing impaired children. Ital J Pediatr. 2011 Jul 14;37:33. doi: 10.1186/1824-7288-37-33.

    PMID: 21756300BACKGROUND
  • Melo RS, Lemos A, Paiva GS, Ithamar L, Lima MC, Eickmann SH, Ferraz KM, Belian RB. Vestibular rehabilitation exercises programs to improve the postural control, balance and gait of children with sensorineural hearing loss: A systematic review. Int J Pediatr Otorhinolaryngol. 2019 Dec;127:109650. doi: 10.1016/j.ijporl.2019.109650. Epub 2019 Aug 21.

    PMID: 31466025BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Khushbakhat Butt, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 10, 2024

Study Start

December 1, 2023

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations