NCT07578896

Brief Summary

The study will be a Randomized Controlled Trial including 22 children aged 6-10 years with deficits in functional mobility and gross motor skills. Participants will be randomly divided into an experimental group (n=11), receiving a seven-stage progressive Maze Balance Board protocol, and a control group (n=11), receiving conventional physical therapy. Both groups will undergo 30-minute sessions, three times per week, for 8 weeks. Eligible participants will be enrolled after guardian consent. Outcomes will be assessed using the Montreal Cognitive Assessment (MoCA) for cognition, Timed Up and Go (TUG) test for functional mobility, and Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) for gross motor skills. Ethical approval will be obtained from Riphah International University, Lahore, and data will be analyzed using SPSS version 27.0.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Oct 2025Jun 2026

Study Start

First participant enrolled

October 28, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Expected
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 5, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

Cognitive impairmentFunctional mobilityGross motor skillsMaze balance board

Outcome Measures

Primary Outcomes (2)

  • Functional Mobility

    Functional mobility will be assessed using the Timed Up and Go (TUG) test as the primary outcome measure. It evaluates a child's ability to stand up from a chair, walk a short distance, turn, return, and sit down, measuring mobility, balance, and functional movement efficiency.

    Baseline, 8 weeks

  • Gross motor Skills

    Gross motor skills will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) as a primary outcome measure. It evaluates motor abilities including balance, coordination, strength, and agility through standardized tasks, providing a reliable measure of overall gross motor performance in children with cognitive impairment.

    Baseline, 8 weeks

Study Arms (2)

Maze Balance Board Training

EXPERIMENTAL

The experimental group (n=11) will receive Maze Balance Board Training in a one-on-one setting, conducted three times per week for 8 weeks. A seven-stage progressive protocol will be followed, where participants advance only after successfully completing each stage, with earlier stages revisited to reinforce learning. Stage 1 involves rotating a marble with hands; Stage 2 focuses on manual maze navigation; Stage 3 develops static balance on a board; Stage 4 includes unassisted rotational balance; Stage 5 introduces foot-mediated marble rotation; Stage 6 requires foot-based maze navigation; and Stage 7 combines dynamic balance with precise marble placement as a dual task. Progression will depend on task performance over consecutive days, aiming to improve functional mobility and gross motor skills in children with cognitive impairment.

Other: Maze Balance Board traing

Conventional Physical Therapy

OTHER

The control group (n=11) will receive conventional physical therapy as a standard-of-care baseline, conducted to improve postural control and gross motor skills. Sessions will include structured exercises performed regularly throughout the study. Activities include animal walks (bear walk, bunny hops, frog jumps) to enhance core and limb strength; bridging exercises to strengthen glutes and hamstrings; sit-to-stand training to improve lower limb strength and functional movement; tandem walking to challenge balance; standing on varied surfaces (foam/cushions) to improve proprioception; beam/line walking forward and backward for coordination and dynamic balance; and obstacle negotiation involving stepping over or around objects. These exercises will be consistently practiced to enhance mobility and motor performance in children with cognitive impairment.

Other: Conventional Physical Therapy

Interventions

The experimental group (n=11) will receive Maze Balance Board Training in a one-on-one setting, conducted three times per week for 8 weeks. A seven-stage progressive protocol will be followed, where participants advance only after successfully completing each stage, with earlier stages revisited to reinforce learning. Stage 1 involves rotating a marble with hands; Stage 2 focuses on manual maze navigation; Stage 3 develops static balance on a board; Stage 4 includes unassisted rotational balance; Stage 5 introduces foot-mediated marble rotation; Stage 6 requires foot-based maze navigation; and Stage 7 combines dynamic balance with precise marble placement as a dual task. Progression will depend on task performance over consecutive days, aiming to improve functional mobility and gross motor skills in children with cognitive impairment.

Maze Balance Board Training

The control group (n=11) will receive conventional physical therapy as a standard-of-care baseline, conducted to improve postural control and gross motor skills. Sessions will include structured exercises performed regularly throughout the study. Activities include animal walks (bear walk, bunny hops, frog jumps) to enhance core and limb strength; bridging exercises to strengthen glutes and hamstrings; sit-to-stand training to improve lower limb strength and functional movement; tandem walking to challenge balance; standing on varied surfaces (foam/cushions) to improve proprioception; beam/line walking forward and backward for coordination and dynamic balance; and obstacle negotiation involving stepping over or around objects. These exercises will be consistently practiced to enhance mobility and motor performance in children with cognitive impairment.

Conventional Physical Therapy

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6-10 years
  • Mild to Moderate Cognitive Impairment (MoCA score =18 to 25)
  • Gross motor skill delay (10).
  • Ability to follow verbal instructions
  • Parents are willing to make sure their child's participation

You may not qualify if:

  • Use of medications that may influence neuromotor functions (e.g., sedatives, antiepileptic's)
  • Children with visual and hearing impairments
  • Receiving concurrent therapies
  • Recent lower limb injuries , surgeries, or musculoskeletal conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imran Amjad, PhD

Lahore, Punjab Province, 05450, Pakistan

RECRUITING

Related Publications (1)

  • Karnad SD, Narayan A, Kamath N, Rao BK, Sharma M, K VK. A protocol to evaluate the effect of Modified Scooter Board Therapy on Trunk Control and Hip muscles Activation in children with Cerebral Palsy. MethodsX. 2025 Apr 5;14:103301. doi: 10.1016/j.mex.2025.103301. eCollection 2025 Jun.

    PMID: 40255464BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Maryam Shafique, MS-PT

    Riphah International University Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif Javed

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocols, and possible efforts will be put to mask both groups about the treatment.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study will be a randomized controlled trial including 22 children aged 6-10 years with deficits in functional mobility and gross motor skills. Participants will be randomly assigned to an experimental group (n=11), following a seven-stage Maze Balance Board protocol, or a control group (n=11), receiving conventional physical therapy. Interventions will be conducted for 30 minutes, three times per week, for 8 weeks. Participants will be screened based on eligibility criteria, and informed consent will be obtained from their guardians. Outcomes will be assessed using the Montreal Cognitive Assessment (MoCA) for cognition, Timed Up and Go (TUG) test for functional mobility, and Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) for gross motor skills. Ethical approval will be obtained from Riphah International University, Lahore, and data will be analyzed using SPSS version 27.0.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 11, 2026

Study Start

October 28, 2025

Primary Completion

May 5, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations