Down Syndrome and Effects of Foot Muscle Exercise

Effects of Foot Muscle Exercise on Gross Motor Function and Balance Among Pes Planus Down Syndrome Patients

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.

Study Overview

• Status: Completed
• Conditions: Pes Planus Down Syndrome Patients
• Intervention / Treatment: Other: Foot Muscle Exercise Protocol; Combination product: Arch Support Insole and One Leg Balance Activities

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75530
      • ACELP (Institute of Child Development)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Foot Muscle Exercise	Other: Foot Muscle Exercise Protocol; Foot Muscle Exercise was given for 3 days per week for 40 minutes for the period of 6 months including home program
Active Comparator: Arch Support Insole and One Leg Balance Activities	Combination product: Arch Support Insole and One Leg Balance Activities; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross Motor Function	Gross Motor Function was assessed using GMFM-88 Dimensions D and E	Baseline
Gross Motor Function	Gross Motor Function was assessed using GMFM-88 Dimensions D and E	12 weeks
Gross Motor Function	Gross Motor Function was assessed using GMFM-88 Dimensions D and E	24 weeks
Balance	Balance was assessed using Pediatric Balance Scale	Baseline
Balance	Balance was assessed using Pediatric Balance Scale	12 weeks
Balance	Balance was assessed using Pediatric Balance Scale	24 weeks

Collaborators and Investigators

• Sponsor: Ziauddin University

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: February 12, 2022
• First Submitted That Met QC Criteria: February 12, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 12, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Down syndrome; exercise training; pes planus; foot deformities; muscle hypotonia; joint laxity
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Musculoskeletal Diseases; Intellectual Disability; Musculoskeletal Abnormalities; Abnormalities, Multiple; Chromosome Disorders; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Syndrome; Down Syndrome; Flatfoot
• Other Study ID Numbers: Nazia Adeeb

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No