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Completed

NCT Number: NCT05251935

Down Syndrome and Effects of Foot Muscle Exercise

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.

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Key information

Conditions

Pes Planus Down Syndrome Patients Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Flatfoot Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Genetic Diseases, Inborn Intellectual Disability Joint Diseases Joint Instability Limb Deformities, Congenital Lower Extremity Deformities, Congenital Muscle Hypotonia Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Talipes

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ACELP (Institute of Child Development)

Karachi, Sindh, 75530, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Foot Muscle Exercise Protocol

Other

Foot Muscle Exercise was given for 3 days per week for 40 minutes for the period of 6 months including home program

Arch Support Insole and One Leg Balance Activities

Combination Product

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 outcomes

  1. Gross Motor Function

    Time frame: Baseline

    Gross Motor Function was assessed using GMFM-88 Dimensions D and E

  2. Gross Motor Function

    Time frame: 12 weeks

    Gross Motor Function was assessed using GMFM-88 Dimensions D and E

  3. Gross Motor Function

    Time frame: 24 weeks

    Gross Motor Function was assessed using GMFM-88 Dimensions D and E

  4. Balance

    Time frame: Baseline

    Balance was assessed using Pediatric Balance Scale

  5. Balance

    Time frame: 12 weeks

    Balance was assessed using Pediatric Balance Scale

  6. Balance

    Time frame: 24 weeks

    Balance was assessed using Pediatric Balance Scale

Sponsors and collaborators

Lead sponsor

Ziauddin University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2022
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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