NCT05392309

Brief Summary

Down syndrome occurs due to abnormal cell division of extra chromosome 21. It is a genetic disorder that causes postural un stability, leads to poor foot function and causes them difficulty that they can't fulfill their daily life activities and can't be independent. Strengthening exercise of lower limb and core strengthening of trunk muscle will provide postural stability and lower limb strengthening. Aim of this research is to determine the effects of manual Ankle rocking training on postural control and foot function in children with Down syndrome. Those who are diagnosed with down syndrome and are between age 8-15 and both of the genders are included in this research and those who have any surgical issue, visual impairment and musculoskeletal contractures are not included in the study we will use static standing balance test to check postural control and foot function index for Ankle rocking training from two group in which one will be given the baseline treatment of lower limb exercise and core strengthening with ankle rocking training and the other group without ankle rocking training and then the collected data will be analyzed by SPSS. 22

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

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

March 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

May 23, 2022

Last Update Submit

January 4, 2023

Conditions

Keywords

Down syndromePostural controlPostural stabilityBalance

Outcome Measures

Primary Outcomes (2)

  • Changes in foot function index score

    A Foot Function Index (FFI) was developed in 1991 to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. It is a self-administered index consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced.

    Baseline and 9th week

  • Static standing balance test

    Static standing balance test for postural control and stability

    baseline and 9th week

Study Arms (2)

Manual ankle rocking training

EXPERIMENTAL

Group will receive manual ankle rocking training with lower limb exercise and core strengthening of trunk

Other: Manual ankle rocking trainingOther: Conventional

conventional

ACTIVE COMPARATOR

Group will receive lower limb exercises and core strengthening of trunk. Sessions will be 4 days in a week

Other: Conventional

Interventions

Group will receive manual ankle rocking training with lower limb exercise and core strengthening of trunk

Manual ankle rocking training

Group will receive lower limb exercises and core strengthening of trunk. Sessions will be 4 days in a week

Manual ankle rocking trainingconventional

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed children with down syndrome
  • Age 8 to 15
  • Both gender (male and female)

You may not qualify if:

  • Musculoskeletal contractures
  • Visual or other sensory input impairment
  • Any surgical procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rising Sun Institute For Special Children, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (8)

  • Balan V, Georgescu M. Postural control in Down syndrome subjects. European Proceedings of Social and Behavioural Sciences. 2019;11.

    BACKGROUND
  • Palomba A, Perez D, Tafuri D. THE EFFECTS OF PHYSICAL ACTIVITY ON BALANCE AND POSTURAL CONTROL IN PEOPLE WITH DOWN SYNDROME.

    BACKGROUND
  • Shields N, Lim P, Wollersheim D, Nikolopoulos N, Barrett J, Evans A, et al. Do foot posture, deformity, and footwear fit influence physical activity levels in children with Down syndrome? A prospective cohort study. Journal of Intellectual & Developmental Disability. 2017;42(4):332-8

    BACKGROUND
  • Wang HY, Long IM, Liu MF. Relationships between task-oriented postural control and motor ability in children and adolescents with Down syndrome. Res Dev Disabil. 2012 Nov-Dec;33(6):1792-8. doi: 10.1016/j.ridd.2012.05.002. Epub 2012 Jun 13.

    PMID: 22699252BACKGROUND
  • Zago M, Duarte NAC, Grecco LAC, Condoluci C, Oliveira CS, Galli M. Gait and postural control patterns and rehabilitation in Down syndrome: a systematic review. J Phys Ther Sci. 2020 Apr;32(4):303-314. doi: 10.1589/jpts.32.303. Epub 2020 Apr 2.

    PMID: 32273655BACKGROUND
  • Eltohamy AM, Mahran MA, Elassal MI, Kamel AH. Ankle Rocking Training and Functional Abilities in Children with Cerebral Palsy. The Egyptian Journal of Hospital Medicine. 2021;85(1):3301-5

    BACKGROUND
  • Chen HL, Yeh CF, Howe TH. Postural control during standing reach in children with Down syndrome. Res Dev Disabil. 2015 Mar;38:345-51. doi: 10.1016/j.ridd.2014.12.024. Epub 2015 Jan 13.

    PMID: 25590172BACKGROUND
  • Brugnaro BH, Oliveira MFP, de Campos AC, Pavao SL, Rocha NACF. Postural control in Down syndrome and relationships with the dimensions of the International Classification of Functioning, Disability and Health - a systematic review. Disabil Rehabil. 2022 Jun;44(11):2207-2222. doi: 10.1080/09638288.2020.1830439. Epub 2020 Oct 13.

    PMID: 33049152BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Sidra Afzal, PP-DPT

    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

May 23, 2022

First Posted

May 26, 2022

Study Start

March 15, 2022

Primary Completion

September 15, 2022

Study Completion

October 31, 2022

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations