NCT06198049

Brief Summary

Static balance is the ability to hold the body in a specific position and posture, while dynamic balance is the ability to maintain balance while moving. Vision, somatosensation, vestibular, and hearing are integrated to achieve balance Ethical committee approval will be obtained. A written consent will be taken from all subjects in the language best understood by them, after fulfilling the inclusion criteria, Patients age 10-14 years will be recruited through Randomized Clinical trial in which convenient sampling technique will be used. Group A 17 participants will receive Pilates training and group B 17 participants will receive balance Proprioception exercises. Pediatric balance scale and Lower Extremity Functional scale will be used .The result after statistical analysis will either show both treatments equally effective or not. Data will be calculated before and after treatment with the help of outcome measure tools.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

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
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 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

Hearing ImpairmentBalancePilates

Outcome Measures

Primary Outcomes (2)

  • Pediatric Balance Scale

    The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.

    Six weeks

  • Lower Extremity Functional Scale

    This consists of 20 questions about a person's capacity to carry out daily chores. Clinicians can use the LEFS to assess patients' initial function, ongoing progress, and outcome, as well as to set functional goals. The maximum score is 80 points, indicating very high function. The minimum possible score is 0 points, indicating very low functions

    Six weeks

Study Arms (2)

Pilates Training

EXPERIMENTAL

Group A 17 participants will receive Pilates training General rehabilitation exercises. Balance and strengthening exercises. Stretching exercises will be performed.Each exercises will be performed with ten repetition for three sessions per week.

Other: Pilates Training

Balance Proprioception Exercises

EXPERIMENTAL

Group B 17 participants will receive balance Proprioception exercises. The training program will consist of 14 basic exercises on and off the balance board, with variations on each exercise. The program will be included four prescribed exercises: (a) exercise without any material, (b) exercise with a ball only, (c) exercise with a balance board only, and (d) exercise with a ball and a balance board. Also for gait and dynamic balance activity training use of Cobblestones walking mat that affects postural control. Walking task on the Cobblestone walking mat included: walking backward, walking sideways, and walking under dim light conditions. Mat walking time per session increased from 6 to 12 min during the acclimation period of the first two sessions and progressed gradually but incrementally to a maximum of 20 min per session over the 12 ensuing sessions.

Other: Balance Proprioception Exercises

Interventions

This group will receive Pilates training General rehabilitation exercises. Balance and strengthening exercises. Stretching exercises will be performed.Each exercises will be performed with ten repetition for three sessions per week

Pilates Training

This group will receive balance Proprioception exercises. The training program will consist of 14 basic exercises on and off the balance board, with variations on each exercise. Mat walking time per session increased from 6 to 12 min during the acclimation period of the first two sessions and progressed gradually but incrementally to a maximum of 20 min per session over the 12 ensuing sessions.

Balance Proprioception Exercises

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Both Gender will be included.
  • Age 10-14 years.
  • No history of lower extremity injuries or neuromuscular problems during the last 6 months
  • Child's physical fitness level to ensure they can safely participate in Pilates and balance proprioceptive exercises.
  • Children having Cochlear implant

You may not qualify if:

  • Patients will be excluded from the study if they had significant cardiac, pulmonary, or metabolic comorbidity or had an active disease that required therapy modification during the study.
  • If pain will be developed in skeletal muscles after training.
  • The presence of a neurologic disease, decompensated organ failure, intra-articular steroid injection or surgery in any joint, active synovitis, active arthritis psychiatric disease, and inability to understand and follow the prescribed exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah international university

Lahore, 54000, Pakistan

Location

Related Publications (1)

  • Mahafza MT, Wilson WJ, Brauer S, Timmer BHB, Hickson L. A Systematic Review of the Effect of Hearing Aids on Static and Dynamic Balance in Adults with Hearing Impairment. Trends Hear. 2022 Jan-Dec;26:23312165221121014. doi: 10.1177/23312165221121014.

    PMID: 36377351BACKGROUND

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

  • Iqra khan, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get a separate protocols and possible efforts will be put to mask the both groups about their treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This will be Randomized Clinical Trial to see the effect of Pilates Training versus Balance Proprioception exercises on lower extremity function in children with hearing impairment
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

January 31, 2024

Study Completion

February 15, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations