CTRI

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CTRI Number

CTRI/2025/05/087744 [Registered on: 28/05/2025] Trial Registered Prospectively

Last Modified On:

27/05/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Nil

Scientific Title of Study

To study the effectiveness of foot strengthening exercises with Kinesio taping on flat feet in children with autism spectrum disorder

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Priya
Designation	MPT Student
Affiliation	Gurugram University
Address	Department of Physiotherapy, Gurugram University, sec-87, Kankrola, Gurugram, Haryana, pin cord- 122001, India Gurgaon HARYANA 122001 India
Phone	9582173667
Fax
Email	priyukadam958@gmail.com

Details of Contact Person
Scientific Query

Name	Bharti Sharma
Designation	Assistant Professor
Affiliation	Gurugram University
Address	Department of Physiotherapy, Sector-87,Kankrola Village, Gurugram University Gurugram, Haryana, 122505,India Gurgaon HARYANA 122001 India
Phone	9899381400
Fax
Email	bhartibpt@gmail.com

Details of Contact Person
Public Query

Name	Bharti Sharma
Designation	Assistant Professor
Affiliation	Gurugram University
Address	Department of Physiotherapy, Sector-87,Kankrola Village, Gurugram University Gurugram, Haryana, 122505,India Gurgaon HARYANA 122001 India
Phone	9899381400
Fax
Email	bhartibpt@gmail.com

Source of Monetary or Material Support

Department of Physiotherapy, Sector-87,Kankrola Village, Gurugram(Haryana), pin cord-122001

Primary Sponsor

Name	Gurugram University
Address	Sector-87,Kankrola Village, Gurugram(Haryana). Pin cord-122001, India
Type of Sponsor	Other [[Gurugram University]]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Priya	CogniAble International Private Limited	sec- 46 Gurugram (Haryana) physiotherapy department ground floor room no 1 Gurgaon HARYANA	09582173667 priyukadam958@gmail.com
Dr Priya	CogniAble International Private Limited	The Child, Sector-46, 122001, Gurugram, Haryana Gurgaon HARYANA	09582173667 priyukadam958@gmail.com

Details of Ethics Committee

No of Ethics Committees= 2
Name of Committee	Approval Status
Institutional Ethical Committee, Department of Physiotherapy, Gurugram University	Approved
Institutional Ethical Committee, Department of Physiotherapy, Gurugram University	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	, (1) ICD-10 Condition: M958\|\|Other specified acquired deformities of musculoskeletal system,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Strengthening Exercises	Heel raise exercise is a static exercise that involves the stabilizing muscles that form the arch of the foot. To strengthen the gastrocnemius, apart from that, heel raise exercises can also improve static balance in children. The heel-raise exercise movement involves the muscles of the lower legs and feet. Duration- The heel raises exercise is carried out 3 times a week for 4 weeks with 10 repetitions in 3 sets Towel curl exercise is an exercise program to improve the morphology of the medial longitudinal arch by activating the intrinsic muscles of the legs. This exercise involves shortening the legs with the toes pulled towards the heels without flexing the legs like "gripping" (Masud 2019). Duration- Exercises were given 3 times a week for 4 weeks with 5 repetitions with resistance for 15 seconds. Ball roll exercise is a strengthening exercise carried out by stepping on and rolling a ball using the sole which aims to stretch the plantar fascia thereby increasing the height of the arch of the foot . Duration- This exercise is given 3 times a week for 4 weeks with a duration of 2 min.
Comparator Agent	Strengthening Exercises along with Kinesiotaping	Heel raise exercise is a static exercise that involves the stabilizing muscles that form the arch of the foot. Duration- The heel raises exercise is carried out 3 times a week for 4 weeks with 10 repetitions in 3 sets Towel curl exercise is an exercise program to improve the morphology of the medial longitudinal arch by activating the intrinsic muscles of the legs. . Duration- Exercises were given 3 times a week for 4 weeks with 5 repetitions with resistance for 15 seconds. Ball roll exercise is a strengthening exercise carried out by stepping on and rolling a ball using the sole which aims to stretch the plantar fascia thereby increasing the height of the arch of the foot . Duration- This exercise is given 3 times a week for 4 weeks with a duration of 2 min. Kinesiotaping - Kinesiotaping has recently become increasingly popular for the management of musculoskeletal impairments, including foot pronation. Kinesio Taping will be applied two times a week for 4 weeks. The first piece of tape was applied on the plantar aspect starting from metatarsal head to calcaneum. The second piece of tape was anchored on the lateral midfoot and then diagonally under calcaneus and medially around posterior ankle. This piece of tape helped to maintain calcaneus in a more neutral position and limit calcaneal eversion.The third piece of tape was anchored on medial midfoot and brought diagonally under calcaneus and laterally around posterior ankle which assisted to “lock” calcaneus in position or “close the loop” for sensory input.The fourth piece of tape extended from the lateral midfoot, over navicular and up the medial distal third of the lower leg, just above the malleolus which supported the midfoot. Along with the taping, the patient was asked to do foot strengthening exercises for 4 weeks.

Inclusion Criteria

Age From	4.00 Year(s)
Age To	12.00 Year(s)
Gender	Both
Details	Children diagnosed by Physician or Psychologist with mild Autism Spectrum Disorder aged between 4 to 12 years. Able to accept and follow simple commands. Flexible flat feet 1 Grade – partial fall of the arch mild 2 Grade – fall of the entire arch moderate 3 Grade – total fall of the arch with valgus deviation of the foot Severe Male and female. Participants.

ExclusionCriteria

Details

Uncooperative child.[14]
If any allergic reactions on skin is seen in children using kinesio taping will be excluded for this study.[16]
Recent or Chronic Injuries Affecting the foot and ankle like- previous fractures or Surgeries of the Ankle joint.[15]
Any metabolic disease like rickets, hypothyroidism or neuropathy subject will be excluded from this study.[15]

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Force Gauges Medial Longitudinal Arch Height by Vernier Caliper	4 weeks

Secondary Outcome

Outcome	TimePoints
Navicular Drop Test	At baseline(day0), Post intervention(Week4)

Target Sample Size

Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 2

Date of First Enrollment (India)

07/06/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="2"
Days="28"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Autism spectrum disorder (ASD) is a neurodevelopmental condition marked by difficulties in social and emotional interactions, along with repetitive behaviors and restricted interests (American Psychiatric Association, 2013). These challenges are often accompanied by reduced physical activity, delayed motor skills, and lower physical fitness, especially in children and adolescents.

With an overall prevalence of 0.3–1.0% Autism Spectrum Disorders (ASD), previously also referred to as Pervasive Developmental Disorders (PDD), cover a wide range of neuropsychological conditions that affect both individual and social functioning (Vandereijcken, Hoogduin, & Emmelkamp, 2006)

Flatfoot prevalence in children typically ranges from 21% to 57% for those aged two to six, and decreases to between 13.4% and 27.6% in primary school-aged children. In adults, the prevalence is generally between 5% and 14%. In children aged 7-14 years, the prevalence of flatfoot is 10.3%, with rates declining as age increases.

Taping is widely used intervention in various conditions treated by physiotherapist. Neurodevelopmental disorders in children leading to foot abnormality is one of the major concern. As taping is one of the Intervention in same the study is focusing taping on pronated feet in the selected age group. The aim of this study was to investigate whether the kinesiotaping and exercise improve pronated feet in neurodevelopmental disordered (NDD) children.

Exercises such as heel raises, towel exercises, and ball exercises target the intrinsic muscles of the legs as well as the muscles surrounding the pelvis, thighs, and knees, which may become imbalanced due to biomechanical changes. This article aims to: 1) Assess the impact of strengthening exercises on postural balance, and 2) Evaluate the effect of these exercises on functional abilities.