Down Syndrome and Effects of Foot Muscle Exercise

Sponsor

Ziauddin University (Other)

Overall Status

Completed

CT.gov ID

NCT05251935

Collaborator

(none)

Enrollment

Location

Arms

7.3

Actual Duration (Months)

6.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pes Planus Down Syndrome Patients	Other: Foot Muscle Exercise Protocol Combination Product: Arch Support Insole and One Leg Balance Activities	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 22, 2021

Actual Primary Completion Date :

Oct 31, 2021

Actual Study Completion Date :

Nov 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Gross Motor Function [Baseline]
Gross Motor Function was assessed using GMFM-88 Dimensions D and E
Gross Motor Function [12 weeks]
Gross Motor Function was assessed using GMFM-88 Dimensions D and E
Gross Motor Function [24 weeks]
Gross Motor Function was assessed using GMFM-88 Dimensions D and E
Balance [Baseline]
Balance was assessed using Pediatric Balance Scale
Balance [12 weeks]
Balance was assessed using Pediatric Balance Scale
Balance [24 weeks]
Balance was assessed using Pediatric Balance Scale