Cognitive ImpairmentNCT07578896
Maze Balance Board Training Effects on Mobility and Motor Skills in Cognitively Impaired Children
A study testing Maze Balance Board traing and Conventional Physical Therapy in people with Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
Trial 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)… Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Maze Balance Board traing and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Oct 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-10 years
- Mild to Moderate Mini Mental State Examination (MMSE score =18 to 25)
- Gross motor skill delay (10).
- Ability to follow verbal instructions
- Parents are willing to make sure their child's participation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Maze Balance Board Training on Functional Mobility and Gross Motor Skills in Children With Cognitive Impairment
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.
Read the detailed description
Difficulties with Functional Mobility, Gross and fine motor skills are common in children with Cognitive Impairment, significantly impacting their ability to perform everyday activities and acquire new motor skills. These difficulties often arise from impaired integration of sensory information and deficits in motor planning, resulting in poor functional mobility and increased risk of instability. As a result, affected children may struggle with maintaining upright positions, transitioning between movements, and executing coordinated actions, all of which are essential for functional mobility and participation in age-appropriate activities. To address these concerns, this study will assess the effects of Maze Balance Board Training on Functional Mobility and Gross Motor Skills in Children with Cognitive Impairment.
The study design will be a Randomized Controlled Trial. The study will recruit 22 children aged 6-10 years with identified deficits in Functional Mobility and Gross motor skills.
Participants will be randomly assigned to either the experimental group (n=11) which will follow a seven-stage progressive Maze Balance board protocol, and a control group (n=11) receiving standard Conventional physical therapy exercises. These interventions will be performed for 30 mins, thrice a week over 8 weeks. All the referred participants will be assessed on the basis of eligibility criteria. Guardians of participants fulfilling the eligibility criteria will be asked to sign the consent forms before entering them to study. This study will utilize three standardized assessment tools to objectively measure Cognition level, Functional Mobility and gross motor skills in children with Cognitive Impairment: Montreal Cognitive Assessment (MoCA) to measure cognition, Time Up and Go (TUG) Test for the functional mobility, While the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) for Gross Motor Skills. The synopsis will be presented to the Research Ethical Committee of Riphah International University, Lahore, for ethical approval to conduct this study. Data will be analyzed through SPSS version 27.0.
- Conditions
- Cognitive Impairment
- Being tested
- Maze Balance Board traing, Conventional Physical Therapy
- Keywords
- Cognitive impairment, Functional mobility, Gross motor skills, Maze balance board
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maze Balance Board traingOther
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.
Conventional Physical TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start28 Oct 2025
- Primary completion5 May 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Shafique, MS-PT, Principal investigator, Riphah International University Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578896
- Sponsor's protocol ID
- REC/RCR&AHS/25/0728
- Status last verified
- Sep 2026
- First submitted
- 5 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40255464
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Maze Balance Board Training on Functional Mobility and Gross Motor Skills in Children With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07578896
- Acronym / sponsor ID
- REC/RCR&AHS/25/0728
- Conditions
- Cognitive Impairment
- Keywords
- Cognitive impairment, Functional mobility, Gross motor skills, Maze balance board
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Difficulties with Functional Mobility, Gross and fine motor skills are common in children with Cognitive Impairment, significantly impacting their ability to perform everyday activities and acquire new motor skills. These difficulties often arise from impaired integration of sensory information and deficits in motor planning, resulting in poor functional mobility and increased risk of instability. As a result, affected children may struggle with maintaining upright positions, transitioning between movements, and executing coordinated actions, all of which are essential for functional mobility and participation in age-appropriate activities. To address these concerns, this study will assess the effects of Maze Balance Board Training on Functional Mobility and Gross Motor Skills in Children with Cognitive Impairment.
The study design will be a Randomized Controlled Trial. The study will recruit 22 children aged 6-10 years with identified deficits in Functional Mobility and Gross motor skills.
Participants will be randomly assigned to either the experimental group (n=11) which will follow a seven-stage progressive Maze Balance board protocol, and a control group (n=11) receiving standard Conventional physical therapy exercises. These interventions will be performed for 30 mins, thrice a week over 8 weeks. All the referred participants will be assessed on the basis of eligibility criteria. Guardians of participants fulfilling the eligibility criteria will be asked to sign the consent forms before entering them to study. This study will utilize three standardized assessment tools to objectively measure Cognition level, Functional Mobility and gross motor skills in children with Cognitive Impairment: Montreal Cognitive Assessment (MoCA) to measure cognition, Time Up and Go (TUG) Test for the functional mobility, While the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) for Gross Motor Skills. The synopsis will be presented to the Research Ethical Committee of Riphah International University, Lahore, for ethical approval to conduct this study. Data will be analyzed through SPSS version 27.0.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Maze Balance Board Training | Experimental | Other: Maze Balance Board traingThe 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. |
| Conventional Physical Therapy | Other | Other: Conventional Physical TherapyThe 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 6-10 years
- Mild to Moderate Mini Mental State Examination (MMSE score =18 to 25)
- Gross motor skill delay (10).
- Ability to follow verbal instructions
- Parents are willing to make sure their child's participation
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maze Balance Board traingThe 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 Training |
| Conventional Physical TherapyThe 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 |
Primary outcome
Functional Mobility
Time frame: Baseline, 8 weeks
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.
Gross motor Skills
Time frame: Baseline, 8 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 40255464Karnad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam Shafique, MS-PT principal investigator
Riphah International University Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maze Balance Board traing and Conventional Physical Therapy in people with Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Mobility (time frame: Baseline, 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07578896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.