Mild Cognitive ImpairmentNCT06974890
Effects of Shuttle Balance Training on Balance , Gait and Postural Control in Children With Mild Cognitive Impairment
A study testing Shuttle Balance Training and Baseline Treatment in people with Mild Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study aims to investigate the impact of Shuttle Balance Training (SBT) on balance, gait, and postural control among children diagnosed with mild cognitive impairment (MCI). Mild cognitive impairment in children often manifests as challenges in cognitive processing, motor coordination, and daily activities that… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Shuttle Balance Training and Baseline Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2025to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with mild cognitive impairment (50-70%IQ)
- Age group from 6 to 12 years
- Both male and female
- Children must have the physical and cognitive ability to engage in the activities
- Children should be in generally good health, without severe medical conditions or orthopedic issues
Who cannot join
- Children with severe cognitive impairment
- Children who have severe neurological disorders
- Children with visual and auditory impairment
- Children with severe sensory processing disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Rising Sun Institute
Lahore, Punjab Province, 54900
asif javed, MS-PT, 923224209422, a.javed@riphah.edu.pk
About this study
This study aims to investigate the impact of Shuttle Balance Training (SBT) on balance, gait, and postural control among children diagnosed with mild cognitive impairment (MCI). Mild cognitive impairment in children often manifests as challenges in cognitive processing, motor coordination, and daily activities that involve balance and movement. The research will employ a randomized controlled trial (RCT) design, involving children aged 6-12 years diagnosed with MCI.
Participants will be randomly assigned to either an experimental group receiving Shuttle Balance Training or a control group receiving standard care or placebo interventions. The Shuttle Balance Training protocol consists of structured sessions focusing on dynamic balance exercises, coordination drills, and proprioceptive challenges using shuttle devices. Training sessions will be conducted thrice weekly over a period of 12 weeks, with each session lasting approximately 45 minutes. The study will be randomized controlled trial. Total __ subjects will be assigned by non probability convenient sampling technique. They were randomly assigned to experimental and control groups. The Berg balance scale, limits of stability test, GOAL test, Timed up and go tools will be used. Tests will be used as outcome measure tools for balance, walk, coordination and Physical activity. All measures will be taken at baseline and at the end of treatment session. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25.0 version. If data will be normally distributed then parametric if not normally distributed than non-parametric test will be apply.
Read the detailed description
This study aims to investigate the impact of Shuttle Balance Training (SBT) on balance, gait, and postural control among children diagnosed with mild cognitive impairment (MCI). Mild cognitive impairment in children often manifests as challenges in cognitive processing, motor coordination, and daily activities that involve balance and movement. The research will employ a randomized controlled trial (RCT) design, involving children aged 6-12 years diagnosed with MCI.
Participants will be randomly assigned to either an experimental group receiving Shuttle Balance Training or a control group receiving standard care or placebo interventions. The Shuttle Balance Training protocol consists of structured sessions focusing on dynamic balance exercises, coordination drills, and proprioceptive challenges using shuttle devices. Training sessions will be conducted thrice weekly over a period of 12 weeks, with each session lasting approximately 45 minutes. The study will be randomized controlled trial. Total __ subjects will be assigned by non probability convenient sampling technique. They were randomly assigned to experimental and control groups.
The Berg balance scale, limits of stability test, GOAL test, Timed up and go tools will be used.
Tests will be used as outcome measure tools for balance, walk, coordination and Physical activity.
All measures will be taken at baseline and at the end of treatment session. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25.0 version. If data will be normally distributed then parametric if not normally distributed than non-parametric test will be apply.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Shuttle Balance Training, Baseline Treatment
- Keywords
- Down syndrome, Shuttle balance training, Mild cognitive impairment, Pediatric balance scale, Berg balance scale
- Medical subject headings
- Cognitive Dysfunction, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shuttle Balance TrainingOther
Shuttle balance training is a form of dynamic balance exercise that uses a shuttle system-often a platform or track with resistance bands or gliders-to help improve stability, coordination, and strength. In children, this type of training plays a significant role in enhancing gait, balance, and posture by engaging core and lower limb muscles in controlled, functional movements. It encourages proprioceptive development, helping children become more aware of their body's position in space, which is crucial for maintaining upright posture and walking efficiently. Through repetitive and playful activities, shuttle balance training can aid in correcting abnormal gait patterns, improving postural alignment, and boosting confidence in physical activities.
Baseline TreatmentOther
Baseline treatment sets a foundation for managing the patient's condition effectively. It ensures that the patient receives appropriate care based on current medical knowledge and guidelines, with the goal of improving health outcomes and quality of life. Duration of session will be 45 min and 3 sessions per week.
Control Group Considerations: Clarifying how participants assigned to the control group will receive standard care or placebo intervention to maintain ethical standards and enable comparison with the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Shuttle Balance Training | Experimental | Shuttle balance training is a dynamic exercise program designed to improve balance, gait, and posture, especially beneficial for children with mild cognitive impairment. It includes activities like shuttle runs, lateral steps, single-leg balances, crossovers, figure-8 drills, obstacle courses, and reaction drills-all aimed at enhancing coordination, stability, and agility. The program typically runs for 45-minute sessions, three times a week. Pre-assessments are used to measure baseline abilities, and progress is monitored throughout. This type of training helps improve motor control, body awareness, and functional movement, leading to better balance, more stable gait, and improved postural control in daily activities. Receives: Other: Shuttle Balance Training |
| Baseline Treatment | Active comparator | "Baseline treatment" refers to the standard or initial treatment that is provided to a patient.
Baseline treatment sets a foundation for managing the patient's condition effectively. It ensures that the patient receives appropriate care based on current medical knowledge and guidelines, with the goal of improving health outcomes and quality of life. Duration of session will be 45 min and 3 sessions per week.
* Control Group Considerations: Clarifying how participants assigned to the control group will receive standard care or placebo intervention to maintain ethical standards and enable comparison with the intervention group.
* Outcome Measures: Specifying the outcome measures and assessment tools used to evaluate the effects of the intervention on balance, gait, and postural control, both immediately after the intervention period and potentially during follow-up assessments. Receives: Other: Baseline Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
A scale that is used to determine the balance in an individual. It has total 14 items, It takes about 20 minutes to complete each item, which has a five-point ordinal scale from 0 to 4, where 0 represents the lowest level of function and 4 the most. It excludes the evaluation of gait.
TOTAL SCORE (Maximum = 56)
Measured: Baseline , 4th week, 8th week & 12th week
Limits of Stability Test
Limits of Stability (LoS) is a key measure for assessing dynamic balance and voluntary motor control by tracking changes in the center of mass (COM). It helps identify postural instability and fall risk by evaluating how far a person can lean or sway without losing balance. LoS Represents the max distance a person can sway intentionally in direction without losing their balance. Normal range is anteroposterior 12.5 degrees, and medio-lateral 16 degrees.
Measured: Baseline , 4th week, 8th week & 12th week
Goal-Oriented Assessment of Life skills (GOAL) Test
A test of functional motor skills required for day-to-day functioning is the Goal-Oriented Assessment of Lifeskills (GOAL). The GOAL program, which is intended for children aged 7 to 17, includes seven enjoyable and inspiring activities that are based on real-life tasks that kids do on a daily basis. The 54 Steps-small units of clearly visible, useful conduct within the seven Activities-are the foundation for the GOAL scores. Three components of successful functional performance-accuracy, independence, and speed-are used to score these. Each Step is graded as pass or fail using the Record Form. The Fine Motor and Gross Motor Standard Scores and the Progress Score are then calculated by adding the Step scores.
Measured: Baseline , 4th week, 8th week & 12th week
The Timed up and Go test.
The timed Up and Go test (TUG) is a relatively simple test used to assess a person's mobility and requires both static and dynamic balance. The patient sits on a standard armchair back against it and resting arm position, regular footwear is used, the patient walks to a line that is 3meters away turns around the line, walks back to the chair and sits down. When the patient's buttocks touches the seat, the test ends there. A stopwatch is used to measure the time. Higher time score indicates high fall risks and less functional independence.
Measured: Baseline , 4th week, 8th week & 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start15 Apr 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion10 Jul 2025 (estimated)
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 Mild 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 randomized controlled trial. Total \_\_ subjects will be assigned by non probability convenient sampling technique. They were randomly assigned to experimental and control groups. The Berg balance scale, limits of stability test, GOAL test, Timed up and go tools will be used. Tests will be used as outcome measure tools for balance, walk, coordination and Physical activity. All measures will be taken at baseline and at the end of treatment session. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25.0 version. If data will be normally distributed then parametric if not normally distributed than non-parametric test will be apply.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ZAHRA AHMAD, MS-PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974890
- Sponsor's protocol ID
- REC/RCR& AHS/24/0744
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jelsma D, Geuze RH, Mombarg R, Smits-Engelsman BC. The impact of Wii Fit intervention on dynamic balance control in children with probable Developmental Coordination Disorder and balance problems. Hum Mov Sci. 2014 Feb;33:404-18. doi: 10.1016/j.humov.2013.12.007. Epub 2014 Jan 18.
PubMed 24444657
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Shuttle Balance Training on Balance , Gait and Postural Control in Children With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06974890
- Acronym / sponsor ID
- REC/RCR& AHS/24/0744
- Conditions
- Mild Cognitive Impairment
- Keywords
- Down syndrome, Shuttle balance training, Mild cognitive impairment, Pediatric balance scale, Berg balance scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 10 Jul 2025 (estimated)
- First posted
- 16 May 2025 (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.
This study aims to investigate the impact of Shuttle Balance Training (SBT) on balance, gait, and postural control among children diagnosed with mild cognitive impairment (MCI). Mild cognitive impairment in children often manifests as challenges in cognitive processing, motor coordination, and daily activities that involve balance and movement. The research will employ a randomized controlled trial (RCT) design, involving children aged 6-12 years diagnosed with MCI.
Participants will be randomly assigned to either an experimental group receiving Shuttle Balance Training or a control group receiving standard care or placebo interventions. The Shuttle Balance Training protocol consists of structured sessions focusing on dynamic balance exercises, coordination drills, and proprioceptive challenges using shuttle devices. Training sessions will be conducted thrice weekly over a period of 12 weeks, with each session lasting approximately 45 minutes. The study will be randomized controlled trial. Total __ subjects will be assigned by non probability convenient sampling technique. They were randomly assigned to experimental and control groups. The Berg balance scale, limits of stability test, GOAL test, Timed up and go tools will be used. Tests will be used as outcome measure tools for balance, walk, coordination and Physical activity. All measures will be taken at baseline and at the end of treatment session. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25.0 version. If data will be normally distributed then parametric if not normally distributed than non-parametric test will be apply.
Detailed description
This study aims to investigate the impact of Shuttle Balance Training (SBT) on balance, gait, and postural control among children diagnosed with mild cognitive impairment (MCI). Mild cognitive impairment in children often manifests as challenges in cognitive processing, motor coordination, and daily activities that involve balance and movement. The research will employ a randomized controlled trial (RCT) design, involving children aged 6-12 years diagnosed with MCI.
Participants will be randomly assigned to either an experimental group receiving Shuttle Balance Training or a control group receiving standard care or placebo interventions. The Shuttle Balance Training protocol consists of structured sessions focusing on dynamic balance exercises, coordination drills, and proprioceptive challenges using shuttle devices. Training sessions will be conducted thrice weekly over a period of 12 weeks, with each session lasting approximately 45 minutes. The study will be randomized controlled trial. Total __ subjects will be assigned by non probability convenient sampling technique. They were randomly assigned to experimental and control groups.
The Berg balance scale, limits of stability test, GOAL test, Timed up and go tools will be used.
Tests will be used as outcome measure tools for balance, walk, coordination and Physical activity.
All measures will be taken at baseline and at the end of treatment session. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25.0 version. If data will be normally distributed then parametric if not normally distributed than non-parametric test will be apply.
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 randomized controlled trial. Total __ subjects will be assigned by non probability convenient sampling technique. They were randomly assigned to experimental and control groups. The Berg balance scale, limits of stability test, GOAL test, Timed up and go tools will be used. Tests will be used as outcome measure tools for balance, walk, coordination and Physical activity. All measures will be taken at baseline and at the end of treatment session. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25.0 version. If data will be normally distributed then parametric if not normally distributed than non-parametric test will be apply.
| Arm | Type | Receives |
|---|---|---|
| Shuttle Balance Training | Experimental | Other: Shuttle Balance TrainingShuttle balance training is a dynamic exercise program designed to improve balance, gait, and posture, especially beneficial for children with mild cognitive impairment. It includes activities like shuttle runs, lateral steps, single-leg balances, crossovers, figure-8 drills, obstacle courses, and reaction drills-all aimed at enhancing coordination, stability, and agility. The program typically runs for 45-minute sessions, three times a week. Pre-assessments are used to measure baseline abilities, and progress is monitored throughout. This type of training helps improve motor control, body awareness, and functional movement, leading to better balance, more stable gait, and improved postural control in daily activities. |
| Baseline Treatment | Active comparator | Other: Baseline Treatment"Baseline treatment" refers to the standard or initial treatment that is provided to a patient. Baseline treatment sets a foundation for managing the patient's condition effectively. It ensures that the patient receives appropriate care based on current medical knowledge and guidelines, with the goal of improving health outcomes and quality of life. Duration of session will be 45 min and 3 sessions per week. * Control Group Considerations: Clarifying how participants assigned to the control group will receive standard care or placebo intervention to maintain ethical standards and enable comparison with the intervention group. * Outcome Measures: Specifying the outcome measures and assessment tools used to evaluate the effects of the intervention on balance, gait, and postural control, both immediately after the intervention period and potentially during follow-up assessments. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children with mild cognitive impairment (50-70%IQ)
- Age group from 6 to 12 years
- Both male and female
- Children must have the physical and cognitive ability to engage in the activities
- Children should be in generally good health, without severe medical conditions or orthopedic issues
Key exclusion criteria (4 listed)
- Children with severe cognitive impairment
- Children who have severe neurological disorders
- Children with visual and auditory impairment
- Children with severe sensory processing disorders
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 |
|---|---|---|
| Shuttle Balance TrainingShuttle balance training is a form of dynamic balance exercise that uses a shuttle system-often a platform or track with resistance bands or gliders-to help improve stability, coordination, and strength. In children, this type of training plays a significant role in enhancing gait, balance, and posture by engaging core and lower limb muscles in controlled, functional movements. It encourages proprioceptive development, helping children become more aware of their body's position in space, which is crucial for maintaining upright posture and walking efficiently. Through repetitive and playful activities, shuttle balance training can aid in correcting abnormal gait patterns, improving postural alignment, and boosting confidence in physical activities. | Other | Shuttle Balance Training |
| Baseline TreatmentBaseline treatment sets a foundation for managing the patient's condition effectively. It ensures that the patient receives appropriate care based on current medical knowledge and guidelines, with the goal of improving health outcomes and quality of life. Duration of session will be 45 min and 3 sessions per week. Control Group Considerations: Clarifying how participants assigned to the control group will receive standard care or placebo intervention to maintain ethical standards and enable comparison with the intervention group. | Other | Baseline Treatment |
Primary outcome
Berg Balance Scale
Time frame: Baseline , 4th week, 8th week & 12th week
A scale that is used to determine the balance in an individual. It has total 14 items, It takes about 20 minutes to complete each item, which has a five-point ordinal scale from 0 to 4, where 0 represents the lowest level of function and 4 the most. It excludes the evaluation of gait. TOTAL SCORE (Maximum = 56)
Limits of Stability Test
Time frame: Baseline , 4th week, 8th week & 12th week
Limits of Stability (LoS) is a key measure for assessing dynamic balance and voluntary motor control by tracking changes in the center of mass (COM). It helps identify postural instability and fall risk by evaluating how far a person can lean or sway without losing balance. LoS Represents the max distance a person can sway intentionally in direction without losing their balance. Normal range is anteroposterior 12.5 degrees, and medio-lateral 16 degrees.
Goal-Oriented Assessment of Life skills (GOAL) Test
Time frame: Baseline , 4th week, 8th week & 12th week
A test of functional motor skills required for day-to-day functioning is the Goal-Oriented Assessment of Lifeskills (GOAL). The GOAL program, which is intended for children aged 7 to 17, includes seven enjoyable and inspiring activities that are based on real-life tasks that kids do on a daily basis. The 54 Steps-small units of clearly visible, useful conduct within the seven Activities-are the foundation for the GOAL scores. Three components of successful functional performance-accuracy, independence, and speed-are used to score these. Each Step is graded as pass or fail using the Record Form. The Fine Motor and Gross Motor Standard Scores and the Progress Score are then calculated by adding the Step scores.
The Timed up and Go test.
Time frame: Baseline , 4th week, 8th week & 12th week
The timed Up and Go test (TUG) is a relatively simple test used to assess a person's mobility and requires both static and dynamic balance. The patient sits on a standard armchair back against it and resting arm position, regular footwear is used, the patient walks to a line that is 3meters away turns around the line, walks back to the chair and sits down. When the patient's buttocks touches the seat, the test ends there. A stopwatch is used to measure the time. Higher time score indicates high fall risks and less functional independence.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 24444657Jelsma D, Geuze RH, Mombarg R, Smits-Engelsman BC. The impact of Wii Fit intervention on dynamic balance control in children with probable Developmental Coordination Disorder and balance problems. Hum Mov Sci. 2014 Feb;33:404-18. doi: 10.1016/j.humov.2013.12.007. Epub 2014 Jan 18.
- 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.
ZAHRA AHMAD, MS-PPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shuttle Balance Training and Baseline Treatment in people with Mild 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: looking for participants now, as of the sponsor's last update on 16 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact : IMRAN AMJAD, PhD (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: Baseline , 4th week, 8th week & 12th week). The study lists 4 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 NCT06974890, 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 16 May 2025.