Down Syndrome and Effects of Foot Muscle Exercise
Primary Purpose
Pes Planus Down Syndrome Patients
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Foot Muscle Exercise Protocol
Arch Support Insole and One Leg Balance Activities
Sponsored by
About this trial
This is an interventional treatment trial for Pes Planus Down Syndrome Patients focused on measuring Down syndrome, foot deformities, muscle hypotonia, pes planus, joint laxity, exercise training
Eligibility Criteria
Inclusion Criteria:
• Clinically diagnosed cases of DS including both male and female.
- Bilateral flexible pes planus on the basis of Navicular Drop Test.
- Able to follow instructions and adhere to the exercise program.
- Ambulating independently.
Exclusion Criteria:
• Visual or auditory impairment.
- Lower limb trauma or surgical intervention past six months.
Sites / Locations
- ACELP (Institute of Child Development)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Foot Muscle Exercise
Arch Support Insole and One Leg Balance Activities
Arm Description
Outcomes
Primary Outcome Measures
Gross Motor Function
Gross Motor Function was assessed using GMFM-88 Dimensions D and E
Gross Motor Function
Gross Motor Function was assessed using GMFM-88 Dimensions D and E
Gross Motor Function
Gross Motor Function was assessed using GMFM-88 Dimensions D and E
Balance
Balance was assessed using Pediatric Balance Scale
Balance
Balance was assessed using Pediatric Balance Scale
Balance
Balance was assessed using Pediatric Balance Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT05251935
First Posted
February 12, 2022
Last Updated
February 12, 2022
Sponsor
Ziauddin University
1. Study Identification
Unique Protocol Identification Number
NCT05251935
Brief Title
Down Syndrome and Effects of Foot Muscle Exercise
Official Title
Effects of Foot Muscle Exercise on Gross Motor Function and Balance Among Pes Planus Down Syndrome Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziauddin 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 (DS) is a common chromosomal pediatric disorder and accounts for approximately 8 % of all congenital anomalies. Children with DS experience delays in Cognitive, Physical, Speech and Language development. Hypotonity and laxity that is part of its features causes delay on motor acquisition. Furthermore it causes musculoskeletal issues and lower extremity malalignment resulting in inefficient and abnormal pattern of movement compromising locomotion and day to day functions therefore, problems for the population further aggravates. Combined effects of these factors causes a high level of stress on foot as it provides the foundation for whole body therefore, individuals with Down syndrome are at risk for foot alignment problems. Pes planus being the most common amongst them and accounts for 91% of the total DS patients diagnosed. Pes planus causes alteration in foot kinetics and kinematics that not only interferes significantly with normal daily life activities as balance and gait but also increases the risk of musculoskeletal injuries. Hence researchers have shown interest in addressing this condition for the effective management of DS population. Conventional treatment approach are the use of insoles, foot orthosis and arch taping however, they fail to produce residual effect. Hence the present study is to determine the role of foot muscles exercises in Down Syndrome having pes planus since its effects are positively recorded in normal population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pes Planus Down Syndrome Patients
Keywords
Down syndrome, foot deformities, muscle hypotonia, pes planus, joint laxity, exercise training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Foot Muscle Exercise
Arm Type
Experimental
Arm Title
Arch Support Insole and One Leg Balance Activities
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Foot Muscle Exercise Protocol
Intervention Description
Foot Muscle Exercise was given for 3 days per week for 40 minutes for the period of 6 months including home program
Intervention Type
Combination Product
Intervention Name(s)
Arch Support Insole and One Leg Balance Activities
Intervention Description
Arch Support Insoles were provided that the child had to wear for 5 hours per day thrice weekly for 6 months plus performed one leg balance activities
Primary Outcome Measure Information:
Title
Gross Motor Function
Description
Gross Motor Function was assessed using GMFM-88 Dimensions D and E
Time Frame
Baseline
Title
Gross Motor Function
Description
Gross Motor Function was assessed using GMFM-88 Dimensions D and E
Time Frame
12 weeks
Title
Gross Motor Function
Description
Gross Motor Function was assessed using GMFM-88 Dimensions D and E
Time Frame
24 weeks
Title
Balance
Description
Balance was assessed using Pediatric Balance Scale
Time Frame
Baseline
Title
Balance
Description
Balance was assessed using Pediatric Balance Scale
Time Frame
12 weeks
Title
Balance
Description
Balance was assessed using Pediatric Balance Scale
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Clinically diagnosed cases of DS including both male and female.
Bilateral flexible pes planus on the basis of Navicular Drop Test.
Able to follow instructions and adhere to the exercise program.
Ambulating independently.
Exclusion Criteria:
• Visual or auditory impairment.
Lower limb trauma or surgical intervention past six months.
Facility Information:
Facility Name
ACELP (Institute of Child Development)
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75530
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Down Syndrome and Effects of Foot Muscle Exercise
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