NCT06673836

Brief Summary

Hearing loss is generally identified initially in life leading to difficulties in communication. In children, vestibular dysfunctions can cause a deficit in gross motor development and balance stability. At an early age, delayed gross motor development can cause impairment in the bilateral vestibular system and sensorineural hearing. The children with balance impairment cannot usually participate in physical activities. Running, cycling, hoping and leading to social isolation3. In Pakistan, 2.49% of the population suffers from some disability; the hearing loss population is 7.4%. In Pakistan, hearing loss is more reported in males as compared to females. According to the non-official data, nearly 1.2 in every 1000 Pakistani children suffer from moderate to severe bilateral hearing loss5. In this, 15% population is suffering from profound and nearly 85% from moderate to severe hearing loss.Children who have vestibular dysfunctions may experience many disorders of the vestibular system.Acute unilateral vestibular loss (AUVL) is the most frequent vestibular dysfunction. The etiology of acute unilateral vestibular loss is unknown, but the studies say it may be due to genetic and acquired causes (inflammatory and viral infections). The symptoms include static

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

September 27, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 3, 2024

Last Update Submit

November 3, 2024

Conditions

Keywords

balancedynamic cyclinggait

Outcome Measures

Primary Outcomes (2)

  • Dynamic gate index

    The Dynamic Gait Index was developed by Anne Shumway-Cook (1995) and has been used with older adults to determine their likelihood of falling. Scores of 19 and less are related to falls in older adults. It tests 8 facets of gait and can be used with an assistive device.

    10-15 min

  • CTSIB TEST

    The test is the therapist\'s version of the Computerized Dynamic Post urography which attempts to measure the way that vision, Vestibular and somatosensory interaction allows us to maintain our balance against the forces of gravity. The test was developed by Shumway Cook and Horak in 1986 and further discussed as a clinical tool in 1987 Patients with uncompensated unilateral vestibular deficits have been shown to have difficulty when visual and support surface information are manipulated.

    10 min

Study Arms (2)

dynamic cycling

EXPERIMENTAL

one group will perform dynamic cycling for 6 consecutive weeks,3 days a week for 30 minutes per session.

Device: DYNAMIC CYCLING

inclined treadmill

EXPERIMENTAL

one group will perform treadmil for 3 days a week with 10 degree inclination for 6 six consecutive weeks.

Device: INCLINED TREAD MILL

Interventions

Balance Training: Exercises focused on improving coordination and balance, such as standing on one leg, walking on uneven surfaces, or using balance boards. Core Strengthening: Strengthening core muscles helps children maintain stability during dynamic movements, such as walking or running. Proprioceptive Training: Exercises that improve awareness of the body's position in space, such as obstacle courses or activities that challenge movement coordination.

Also known as: Balance Training: Exercises focused on improving coordination and balance, such as standing on one leg, walking on uneven surfaces, or using balance boards. Core Strengthening: Strengthening core musc, inclined treadmill training is a powerful tool for addressing the balance and gait challenges faced by hearing-impaired children. Through gradual and progressive training, this intervention helps to s
dynamic cycling

Dynamic Cycling: Refers to the fluctuating nature of movement patterns, often used in therapies like stationary biking or recumbe.nt cycling, where the intensity and resistance vary. Dynamic cycling can also refer to training that involves alternating between high and low-intensity phases or cycling between different positions (sitting, standing) or speeds during the activity

Also known as: dynamic cyling
inclined treadmill

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • children with any acute or chronic disease recurrent falls history of any MSK disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

  • Strader DB, Wright T, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004 Apr;39(4):1147-71. doi: 10.1002/hep.20119. No abstract available.

    PMID: 15057920BACKGROUND

Study Officials

  • Asra Ghafoor, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad Dr, PhD

CONTACT

Muhammad Asif Javed, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participant will get separate treatment protocols and possible effort will be put to mask the both group about the treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallal assignment. it will be randomized controlled study,in which probability convenient sampling will be usd.two groups of hearing impaired children will be randomly divided.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2024

First Posted

November 5, 2024

Study Start

September 27, 2024

Primary Completion

November 28, 2024

Study Completion

December 30, 2024

Last Updated

November 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations