Mild Cognitive ImpairmentCMNCT06719297
Cognitive Integrated Motor Training (CM) to Improve Gait and Balance and Reduce Falls in Older Adults With Mild Cognitive Impairment
A study testing Personalized cognitive-sensorimotor VR/MR training in people with Mild Cognitive Impairment, run by Kessler Foundation at 1 site in United States.
Trial summary
Problems with walking and balance are common in older adults with mild cognitive impairment. Walking and balance problems limit independence and increase risk for injuries due to falls. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Personalized cognitive-sensorimotor VR/MR training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 31 Aug 2027
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Between the age of 65 and 85 years for older adults.
- Montreal Cognitive Assessment (MOCA), 17 < MOCA < 24
- Medical clearance will be obtained from my clinician. If participants physician is unavailable the study team clinician will provide the medical clearance.
- Adequate cognitive function to give informed consent, understand the training and instructions, use the device and give adequate feedback.
- Able to stand for 5 minutes.
Who cannot join
- Body weight over 135 kgs.
- Uncontrolled or unstable seizure disorder.
- Severe joint contracture or spasticity of the ankle that limits passive range of motion as determined by the team.
- History of severe cardiac diseases such as myocardial infarction, coronary artery disease, cardiac arrhythmia, or congestive heart failure.
- Neuromuscular or neurological pathologies (e.g., spinal cord injury, stroke) that will interfere with ambulation.
- Uncontrolled or unstable orthostatic hypotension.
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- Pre-existing conditions resulting in significant disruption in alignment or function of the lower limb during standing.
- History of injury or pathology to the lower limbs in the past 6 months or any medical issue precludes full weight-bearing and ambulation (e.g., orthopedic injuries).
- Diplopia or nystagmus.
- Walking speed from 10MWT >0.8m/s.
- MRI specific exclusion criteria:
- Medications such as: steroids, benzodiazepines, and neuroleptics. The study doctor will review the medications with the participant.
- clip to repair a cerebral aneurysm (broken blood vessel in the head), cardiac pace-maker, cochlear implants (internal hearing aids) or metal fragments or pieces in the eyes or any other part of the body.
- non MRI compatible metal in any part of the body.
- Medical clearance from a physician that it is medically unsafe to receive regular MRI.
- Engage in the professions of painting or welding or other occupation that prevents me from getting a regular MRI.
- claustrophobia (fear of enclosed spaces).
- History of schizophrenia or bipolar disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kessler Foundation
West Orange, New Jersey, 07052
Kiran Karunakaran, PhD, 551-358-3672, kirankarun@gmail.com
Kiran Karunakaran, PhD
About this study
Official title: Cognitive Integrated Motor Training to Improve Gait and Balance and Reduce Falls in Older Adults With Mild Cognitive Impairment
Problems with walking and balance are common in older adults with mild cognitive impairment. Walking and balance problems limit independence and increase risk for injuries due to falls. The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized cognitive integrated sensorimotor virtual reality (VR)/mixed reality (MR) training on walking and balance ability. The study will also help to understand the changes in thinking ability and brain activity as a result of this training in older adults with mild cognitive impairment.
The study will evaluate the differences between two intervention groups (n=20 each): 1) personalized cognitive integrated sensorimotor VR/MR training (CM), and 3) standard of care (CTRL) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CM.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Personalized cognitive-sensorimotor VR/MR training, Standard of Care
- Keywords
- older adults, mild cognitive impairment, gait, balance
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized cognitive-sensorimotor VR/MR trainingOther
Thinking task integrated walking and balance training program
Standard of CareOther
Standard walking and balance training
| Study group | Role | What they receive |
|---|---|---|
| Personalized cognitive-sensorimotor VR/MR training | Experimental | Thinking task integrated walking and balance training program Receives: Other: Personalized cognitive-sensorimotor VR/MR training |
| Standard of Care | Active comparator | Standard walking and balance training Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG)
TUG is a clinical test of functional gait abilities and dynamic balance. The participants will be asked to walk a distance of 3 meters from a seated position, turn around, walk back to the chair and sit back in the chair. The time taken to perform the task will be recorded using a stop watch. The TUG will be repeated multiple times. The participant may be asked to hold a plastic cup or count backwards by three from a randomly selected number while walking.
Measured: 10 weeks
10 Meter walk test
Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.
Measured: 10 weeks
Berg balance Assessment
This is a test that measures balance on a 5-point during routine tasks. The participant will be asked to perform 14 tasks involving: sitting, standing, reaching, lifting, and turning.
Measured: 10 weeks
Fall Risk
The silver index will be measured using the Hunova (Movendo Srl., Italy) to quantify the risk of falls. The Silver Index tasks include static balance while eyes are open or closed, dynamic balance while standing on passive and elastic surfaces, limits of stability, reactive balance during perturbations, 6-meter walk, and sit-to-stand.
Measured: 10 weeks
Balance
Root-mean-square of COM and COP displacements will be used to quantify balance tasks. COP will be obtained from Hunova. Whole body COM will be obtained using motion capture.
Measured: 10 weeks
Temporal characteristics
This test assesses deviations in timing of steps during walking.
Measured: 10 weeks
Spatial characteristics
This test assesses deviations in steplength during walking.
Measured: 10 weeks
Physiological
The participants will wear small sensors on their body to assess the activity of the brain and muscles during walking and balancing tasks.
Measured: 10 weeks
Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV])
This test assesses attention and working memory.
Measured: 10 weeks
Flanker Inhibitory Control and Attention Test
This test assesses the allocation of limited attentional capacities to deal with an abundance of environmental stimulation. The test measures attention and the ability to inhibit response that may interfere with the ability to achieve goals.
Measured: 10 weeks
Symbol Digit Modalities Test (SDMT)
This test assesses processing speed without a motor component
Measured: 10 weeks
Paced Auditory Serial Addition Test (PASAT)
This test assesses information processing speed \& ability and working memory
Measured: 10 weeks
Letter-Number Sequencing (WAIS-IV)
This test assesses working memory
Measured: 10 weeks
Delis-Kaplan Executive Function System
Selected subtests to assess executive function.
Measured: 10 weeks
Community Ambulation
This test quantifies the amount of physical activity in the community using IMU sensors that participants will wear.
Measured: 10 weeks
Continuous Performance Task
This test assesses attention.
Measured: 10 weeks
Magnetic Resonance Imaging (MRI)
MRI scans will be performed to assess the structure and function of the brain while the participant is lying quietly in the MRI scanner.
Measured: 1 week
Secondary outcomes (2)
6 Minute Walk Test
Participants walk as far as possible for 6 minutes. They walk back and forth around the cones along an unobstructed pathway of 15 meters. They will be permitted to slow down or stop as necessary. The distance covered by the participant for the 6 minutes will be recorded at an interval of every 30 seconds using a measuring wheel and stop watch.
Measured: 10 weeks
Dynamic Gait Index (DGI)
DGI is a measurement tool commonly used to assess dynamic balance, gait and risk for falls29. It consists of a total of eight gait assessments which can be scored on a four-point ordinal scale, ranging from 0-3, where '0' indicates the lowest level of function and '3' the highest level of function, allowing for a total possible score of 24.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers University, New Jersey Institute of Technology
- Responsible party
- Principal investigator, Kiran Karunakaran, Kessler Foundation
- Investigators
- Kiran Karunakaran, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719297
- Sponsor's protocol ID
- R-1276-24
- Other IDs
- 90IFRE0092
- Acronym
- CM
- Status last verified
- Dec 2024
- First submitted
- 18 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Integrated Motor Training to Improve Gait and Balance and Reduce Falls in Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06719297
- Acronym / sponsor ID
- CM / R-1276-24
- Conditions
- Mild Cognitive Impairment
- Keywords
- older adults, mild cognitive impairment, gait, balance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Rutgers University, New Jersey Institute of Technology
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Dec 2024 (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.
Problems with walking and balance are common in older adults with mild cognitive impairment. Walking and balance problems limit independence and increase risk for injuries due to falls. The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized cognitive integrated sensorimotor virtual reality (VR)/mixed reality (MR) training on walking and balance ability. The study will also help to understand the changes in thinking ability and brain activity as a result of this training in older adults with mild cognitive impairment.
The study will evaluate the differences between two intervention groups (n=20 each): 1) personalized cognitive integrated sensorimotor VR/MR training (CM), and 3) standard of care (CTRL) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized cognitive-sensorimotor VR/MR training | Experimental | Other: Personalized cognitive-sensorimotor VR/MR trainingThinking task integrated walking and balance training program |
| Standard of Care | Active comparator | Other: Standard of CareStandard walking and balance training |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Between the age of 65 and 85 years for older adults.
- Montreal Cognitive Assessment (MOCA), 17 < MOCA < 24
- Medical clearance will be obtained from my clinician. If participants physician is unavailable the study team clinician will provide the medical clearance.
- Adequate cognitive function to give informed consent, understand the training and instructions, use the device and give adequate feedback.
- Able to stand for 5 minutes.
Key exclusion criteria (18 listed)
- Body weight over 135 kgs.
- Uncontrolled or unstable seizure disorder.
- Severe joint contracture or spasticity of the ankle that limits passive range of motion as determined by the team.
- History of severe cardiac diseases such as myocardial infarction, coronary artery disease, cardiac arrhythmia, or congestive heart failure.
- Neuromuscular or neurological pathologies (e.g., spinal cord injury, stroke) that will interfere with ambulation.
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 |
|---|---|---|
| Personalized cognitive-sensorimotor VR/MR trainingThinking task integrated walking and balance training program | Other | Personalized cognitive-sensorimotor VR/MR training |
| Standard of CareStandard walking and balance training | Other | Standard of Care |
Primary outcome
Timed Up and Go (TUG)
Time frame: 10 weeks
TUG is a clinical test of functional gait abilities and dynamic balance. The participants will be asked to walk a distance of 3 meters from a seated position, turn around, walk back to the chair and sit back in the chair. The time taken to perform the task will be recorded using a stop watch. The TUG will be repeated multiple times. The participant may be asked to hold a plastic cup or count backwards by three from a randomly selected number while walking.
10 Meter walk test
Time frame: 10 weeks
Participants will be asked to walk about 12 meters. The time taken to walk 10 meters will be recorded.
Berg balance Assessment
Time frame: 10 weeks
This is a test that measures balance on a 5-point during routine tasks. The participant will be asked to perform 14 tasks involving: sitting, standing, reaching, lifting, and turning.
Fall Risk
Time frame: 10 weeks
The silver index will be measured using the Hunova (Movendo Srl., Italy) to quantify the risk of falls. The Silver Index tasks include static balance while eyes are open or closed, dynamic balance while standing on passive and elastic surfaces, limits of stability, reactive balance during perturbations, 6-meter walk, and sit-to-stand.
Balance
Time frame: 10 weeks
Root-mean-square of COM and COP displacements will be used to quantify balance tasks. COP will be obtained from Hunova. Whole body COM will be obtained using motion capture.
Temporal characteristics
Time frame: 10 weeks
This test assesses deviations in timing of steps during walking.
Spatial characteristics
Time frame: 10 weeks
This test assesses deviations in steplength during walking.
Physiological
Time frame: 10 weeks
The participants will wear small sensors on their body to assess the activity of the brain and muscles during walking and balancing tasks.
Digit Span (Wechsler Adult Intelligence Scale [WAIS-IV])
Time frame: 10 weeks
This test assesses attention and working memory.
Flanker Inhibitory Control and Attention Test
Time frame: 10 weeks
This test assesses the allocation of limited attentional capacities to deal with an abundance of environmental stimulation. The test measures attention and the ability to inhibit response that may interfere with the ability to achieve goals.
Symbol Digit Modalities Test (SDMT)
Time frame: 10 weeks
This test assesses processing speed without a motor component
Paced Auditory Serial Addition Test (PASAT)
Time frame: 10 weeks
This test assesses information processing speed \& ability and working memory
Letter-Number Sequencing (WAIS-IV)
Time frame: 10 weeks
This test assesses working memory
Delis-Kaplan Executive Function System
Time frame: 10 weeks
Selected subtests to assess executive function.
Community Ambulation
Time frame: 10 weeks
This test quantifies the amount of physical activity in the community using IMU sensors that participants will wear.
Continuous Performance Task
Time frame: 10 weeks
This test assesses attention.
Magnetic Resonance Imaging (MRI)
Time frame: 1 week
MRI scans will be performed to assess the structure and function of the brain while the participant is lying quietly in the MRI scanner.
2 secondary outcomes
6 Minute Walk Test
Time frame: 10 weeks
Dynamic Gait Index (DGI)
Time frame: 10 weeks
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 5 Dec 2024.
- 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.
Kiran Karunakaran principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized cognitive-sensorimotor VR/MR training in people with Mild Cognitive Impairment, run by Kessler Foundation at 1 site in United States.
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 18 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: opening soon, as of the sponsor's last update on 5 Dec 2024. 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 United States. 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 Kiran Karunakaran, PhD (5513583672, kirankarun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) (time frame: 10 weeks). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2024.