NCT07619807

Brief Summary

A randomized clinical trial will be conducted at Realm Educational School. Children aged 6-12 years will be randomly assigned to either the AFE or DBT group using convenient sampling. Participants must be physically active and free from neurological, orthopedic, or cognitive impairments, while those with sensory impairments or recent musculoskeletal injuries will be excluded. Outcome measures will include the Pediatric Balance Scale (PBS), Y-Balance Test, Observational Gait Scale (OGS), Timed Up and Go (TUG) test, and BOT-2. Pre- and post-intervention assessments will evaluate the effectiveness of both interventions on balance, gait, mobility, and motor coordination.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

June 2, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

December 14, 2025

Last Update Submit

June 1, 2026

Conditions

Keywords

Balance, Motor coordination, Gait, Frenkel Exercises

Outcome Measures

Primary Outcomes (5)

  • Pediatric Balance Scale

    Assesses functional balance in children through 14 task-based items. Scale Range: 0-56 Interpretation: Higher scores indicate better balance performance.

    10 weeks

  • Y Balance Test - Pediatric version

    The Y Balance Test is a dynamic balance assessment that measures a child's ability to maintain single-leg stance while reaching in three directions: anterior, posteromedial, and posterolateral. Scale Range: Reach distance measured in centimeters (%) normalized to limb length. Interpretation: Higher reach distances indicate better dynamic balance and postural control.

    10 weeks

  • Observational Gait Scale

    Evaluates gait parameters, including stance, swing, and foot placement during walking. Scale Range: 0-22 Interpretation: Higher scores indicate better gait performance.

    10 weeks

  • Timed Up and Go Test

    Measures functional mobility and dynamic balance during sit-to-stand, walking, turning, and sitting. Scale Range: Measured in seconds (no fixed minimum or maximum score). Interpretation: Lower completion times indicate better functional mobility and balance performance.

    10 weeks

  • Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) - Selected subtests

    Assesses gross motor coordination, bilateral coordination, and balance in children.

    10 weeks

Study Arms (2)

Adapted Frenkle Exercises

EXPERIMENTAL

For 10 weeks, 40 minutes session, twice a week. Frenkle Exercises will be perform from simple to complex ones. These are coordinated exercises that improve motor function, proprioception and balance.

Behavioral: Adapted Frenkle Exercises

Dynamic Balance Training

EXPERIMENTAL

For 10 weeks, dynamic balance training will be performed for 40 minutes in each session. These activities involve the sensory system and require muscle power and coordination.

Behavioral: Dynamic Balance Training

Interventions

Participants will receive adapted Frenkel exercises progressing from simple to complex movements, focusing on controlled, precise lower-limb movements to improve coordination and balance. Sitting: Controlled leg movements (side leg placement to floor markers, drawing shapes with toes, slow leg lifts). Standing: Marching in place, side leg lifts, and controlled weight shifting. Walking drills: Straight-line walking with visual cues, step-and-stop walking, and figure-8 walking to negotiate obstacles.

Adapted Frenkle Exercises

Participants will receive dynamic balance training emphasizing postural control, coordination, strength, and functional balance through varied movement tasks. Mat-based balance exercises Rope activities (e.g., jumping) Balance equipment and ground-based balance tasks Paired movements, rhythm and coordination activities, stepping stones, and non-dominant limb tasks

Dynamic Balance Training

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy school-going children aged 8-10 years
  • Both male and female participants
  • No history of neurological, orthopedic, or developmental disorders
  • Informed parental consent and child assent obtained
  • MMSE score ≥ 24
  • TUG score \< 20 seconds
  • Pediatric Berg Balance Scale score ≥ 40

You may not qualify if:

  • History of diagnosed balance or coordination issues.
  • Children with orthopedic and motor impairments.
  • Behavior or attention disorders limiting participation.
  • Neuromuscular conditions, Visual and mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Center, Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Mani H, Miyagishima S, Kozuka N, Inoue T, Hasegawa N, Asaka T. Development of the Relationships Among Dynamic Balance Control, Inter-limb Coordination, and Torso Coordination During Gait in Children Aged 3-10 Years. Front Hum Neurosci. 2021 Oct 28;15:740509. doi: 10.3389/fnhum.2021.740509. eCollection 2021.

    PMID: 34776908BACKGROUND

Study Officials

  • Mehwish Javed, MS-PPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Khadija Liaquat MS-NMPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2025

First Posted

June 2, 2026

Study Start

June 1, 2026

Primary Completion

July 1, 2026

Study Completion

August 1, 2026

Last Updated

June 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations