Down Syndrome and Effects of Foot Muscle Exercise

NCT ID: NCT05251935

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-22
• Study Completion Date: 2021-11-30

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.

Conditions

Pes Planus Down Syndrome Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Foot Muscle Exercise

Group Type: EXPERIMENTAL

Foot Muscle Exercise Protocol

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Arch Support Insole and One Leg Balance Activities

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziauddin University

OTHER

Sponsor Role: lead

Responsible Party

Nazia Adeeb

Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ACELP (Institute of Child Development)

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

Nazia Adeeb

Identifier Type: -

Identifier Source: org_study_id