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Manual Ankle Rocking Training on Postural Control and Foot Function in Children With Down Syndrome

Primary Purpose

Down S Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Manual ankle rocking training
Conventional
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down S Syndrome focused on measuring Down syndrome, Postural control, Postural stability, Balance

Eligibility Criteria

8 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Rising Sun Institute For Special Children, Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual ankle rocking training

conventional

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Static standing balance test
Static standing balance test for postural control and stability

Secondary Outcome Measures

Full Information

First Posted
May 23, 2022
Last Updated
January 4, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05392309
Brief Title
Manual Ankle Rocking Training on Postural Control and Foot Function in Children With Down Syndrome
Official Title
Effects of Manual Ankle Rocking Training on Postural Control and Foot Function in Children With Down Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down S Syndrome
Keywords
Down syndrome, Postural control, Postural stability, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual ankle rocking training
Arm Type
Experimental
Arm Description
Group will receive manual ankle rocking training with lower limb exercise and core strengthening of trunk
Arm Title
conventional
Arm Type
Active Comparator
Arm Description
Group will receive lower limb exercises and core strengthening of trunk. Sessions will be 4 days in a week
Intervention Type
Other
Intervention Name(s)
Manual ankle rocking training
Intervention Description
Group will receive manual ankle rocking training with lower limb exercise and core strengthening of trunk
Intervention Type
Other
Intervention Name(s)
Conventional
Intervention Description
Group will receive lower limb exercises and core strengthening of trunk. Sessions will be 4 days in a week
Primary Outcome Measure Information:
Title
Changes in foot function index score
Description
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.
Time Frame
Baseline and 9th week
Title
Static standing balance test
Description
Static standing balance test for postural control and stability
Time Frame
baseline and 9th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed children with down syndrome Age 8 to 15 Both gender (male and female) Exclusion Criteria: Musculoskeletal contractures Visual or other sensory input impairment Any surgical procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidra Afzal, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rising Sun Institute For Special Children, Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Balan V, Georgescu M. Postural control in Down syndrome subjects. European Proceedings of Social and Behavioural Sciences. 2019;11.
Results Reference
background
Citation
Palomba A, Perez D, Tafuri D. THE EFFECTS OF PHYSICAL ACTIVITY ON BALANCE AND POSTURAL CONTROL IN PEOPLE WITH DOWN SYNDROME.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
22699252
Citation
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.
Results Reference
background
PubMed Identifier
32273655
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
25590172
Citation
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.
Results Reference
background
PubMed Identifier
33049152
Citation
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.
Results Reference
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Manual Ankle Rocking Training on Postural Control and Foot Function in Children With Down Syndrome

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