FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070632 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 13/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of neurobic exercises program along with conventional balance exercises on risk of fall in elderly with mild cognition impairment. 
Scientific Title of Study   Added Effect Of Neurobic Exercises Program Along With Conventional Exercises On Risk Of Fall In Community-Dwelling Elderly With Mild Cognitive Impairment. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nisha Maskar  
Designation  MPT 
Affiliation  Maeers physiotherapy college, Talegaon Dabhade,Pune. 
Address  Maeers physiotherapy college,Near railway station, second floor, Neurophysiotherapy department,cabin no. A-230, Talegaon Dabhade,Pune

Pune
MAHARASHTRA
410506
India 
Phone  8308359003  
Fax    
Email  nishamaskar32@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr sumitra sakhwalkar  
Designation  Professor  
Affiliation  Maeers physiotherapy college, Talegaon Dabhade,Pune . 
Address  Maeers physiotherapy college,Near railway station, second floor, Neurophysiotherapy department,cabin no. A-230, Talegaon Dabhade,Pune

Pune
MAHARASHTRA
410506
India 
Phone  9049998861  
Fax    
Email  sumitra26@mitmimer.com  
 
Details of Contact Person
Public Query
 
Name  Dr sumitra sakhwalkar  
Designation  Professor  
Affiliation  Maeers physiotherapy college, Talegaon Dabhade,Pune . 
Address  Maeers physiotherapy college,Near railway station, second floor, Neurophysiotherapy department,cabin no. A-230, Talegaon Dabhade,Pune

Pune
MAHARASHTRA
410506
India 
Phone  9049998861  
Fax    
Email  sumitra26@mitmimer.com  
 
Source of Monetary or Material Support  
Maeers physiotherapy college 2nd floor neurophysiotherapy department Talegaon Dabhade Pune 410506 
 
Primary Sponsor  
Name  Maeers physiotherapy college Talegaon Dabhade Pune  
Address  Maeers physiotherapy college,near railway station, second floor, neurophysiotherapy department,cabin no - A- 230, Talegaon Dabhade Pune -410506 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sumitra Sakhwalkar  Maeers physiotherapy college talegoan dabhade  maeers physiotherapy college near railway station second floor neurophysiotherapy department cabin no A-230 talegaon dabhade pune
Pune
MAHARASHTRA 
9049998861

sumitra26@mitmimer.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maeers college of physiotherapy ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Community dwelling elderly with mild cognitive impairment  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional balance exercises   Flexibility: stretching calf, hamstring, quadriceps, hip flexors & hip adductors (15 sec hold and 5 repetitions). Strength: abdominal (curl-ups), spinal extensors (prone extension), hip abductors (side lying with a weight around the ankle in progression), hip extensors (in prone), hamstring (prone knee flexion), and quadriceps (knee extension in high sitting): all exercises are given for 10 repetitions. 3. Postural control: stepping in all directions, reaching to limits of stability in different positions (kneeling, half kneeling, standing: on hard surface and foam surface), step up and down, tandem standing and walking, single limb standing (eyes open and closed). 10reps each. walking for 10 minutes at a self-selected comfortable pace on a level surface surfaces and general. Conventional balance exercises for 20-30 minutes 4 days per week for 3 weeks 
Intervention  Neurobics   The term "neurobic" was first introduced by neurobiologists katz and rubin. Neurobic exercises use all five senses - vision, smell, touch, taste, and hearing - as well as emotional senses to improve the brains natural ability to form connections between different types of information. Neurobic exercise is a scientifically substantiated intervention for enhancing brain function or cognitive training to maintain an active and healthy brain. It entails challenging the human brain by exposing it to novel sensations or tasks beyond the usual routine. Neurobic exercise can activate various regions of the brain and prevent a decline in memory performance, while also maintaining a consistent level of cognitive function. This may enhance memory retention. Neurobic exercises can help activate neural systems, increase blood supply to the brain, and enhance nerve impulses and interconnections among different data within the brain. The neurobic exercise protocol will be conducted four days a week for 3 weeks. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 MMSE (score 18 to 24 MCI will be considered)
2 Berg balance scale - (21 and above with moderate and low risk of fall) 
 
ExclusionCriteria 
Details  1 Elderly with a history of allergies to the food or flowers used in the
neurobics program.
2 No history of psychiatric disorders or neurological conditions.
3 Subjects with diagnosed Anosmia . 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Berg balance scale   baseline pre 0 week and post intervention of 3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Mild cognitive impairment is a term used to describe a decline in cognitive abilities that is greater than expected with normal aging, but not severe enough to interfere with daily life.
The prevalence of MCI varies significantly across different regions of the world, with reported percentages ranging from 3% to 42%. In India, previous studies have estimated the prevalence to be between 15% and 33%. These numbers
highlight the significant impact of MCI on a global scale.2
Studies indicate that there exists a connection between cognitive and balance function, which could be attributed to either structural or functional alterations in the brain. According to research, it has been found that the volume of the hippocampus, a part of the brain responsible for learning and memory, is linked to the maintenance of upright posture and balance. The maintenance of balance in the human body is a complex process that involves the processing of information from three sources: the vestibular function, visual sense, and somatosensory sense. This information is then integrated and processed within the central nervous system, ultimately resulting in output to the vestibule-ocular reflex and musculoskeletal system. Research has revealed that the shrinkage of gray matter in the brain can lead to both cognitive decline and postural instability. To be more specific, a study. conducted by makizako et al. Showed that older adults with mild cognitive impairment (MCI) are more prone to falls when their gray matter densities in the middle frontal gyrus and superior frontal gyrus are lower. This highlights the importance of maintaining healthy brain function to prevent falls and other related issues in older adults. The term "neurobic" was first introduced by neurobiologists katz and rubin.
Neurobic exercises use all five senses - vision, smell, touch, taste, and hearing - as well as emotional senses to improve the brain’s natural ability to form connections between different types of information. Neurobic exercise is a scientifically substantiated intervention for enhancing brain function or cognitive training to maintain an active and healthy brain. It entails challenging the human brain by exposing it to novel sensations or tasks beyond the usual routine. Neurobic exercise can activate various regions of the brain and prevent a decline in memory performance, while also maintaining a consistent level of cognitive function. This may enhance memory retention.
Neurobic exercises can help activate neural systems, increase blood supply to the brain, and enhance nerve impulses and interconnections among different data within the brain .Balance is a multifactorial function & Neurobic exercises are scientifically proven to improve the brain’s ability to form connections between different types of information through a multisensory approach.
Despite the growing interest in the use of neurobic exercises to reduce fall risks in older adults, there is a notable lack of empirical evidence supporting their effectiveness in the community-dwelling population. Balance training along with neurobic can improve the overall quality of life for older adults. If the study shows positive outcomes, it could contribute to enhancing the well-being of individuals with mild cognitive impairment by mitigating the risk of falls.
This suggests a need for further research in this area to determine the potential benefits of these exercises and to develop appropriate intervention strategies for this particular population. which in turn will have impact on balance.
Procedure 
Conventional protocol to improve balance (group A)
1. Flexibility: stretching calf, hamstring, quadriceps, hip flexors & hip adductors (15 sec hold and 5 repetitions).
2. Strength: abdominal (curl-ups), spinal extensors (prone extension), hip abductors (side lying with a weight around the ankle in progression), hip extensors (in prone),hamstring(prone knee flexion), and quadriceps(knee extension in high sitting): all exercises are given for 10 repetitions.
3. Postural control: stepping in all directions, reaching to limits of stability in different positions (kneeling, half kneeling, standing: on hard surface and foam surface), step up and down, tandem standing and walking, single limb standing (eyes open and closed). 10 reps each. walking for 10 minutes at a self-selected comfortable pace on a level surface surfaces and general.
Conventional balance exercises for 20-30 minutes 4 days per week for 3 weeks.
The neurobic exercise program -6 sessions ( Group B- experimental)
1. Stimulation of visual sense through a tray game,
2. Stimulation of smell sense through the use of natural aroma,
3. Stimulation of hearing sense through listening and identifying nature sounds,
4. Stimulation of the sense of touch through the writing and guessing words and a puzzle box game,
5. Stimulation of taste sense by tasting food items and
6. integration of multi-senses stimulation.
7. The intervention twice a week for three consecutive weeks. Each session lasts approximately 60 minutes.
Session 1 Visual sense stimulation
Introduce the participants to the neurobic exercise involving 5 senses,using a game form & providing psychoeducation on "how to use the neurobic exercises in your daily life"
Playing a tray game:
The interventionist will place ten common household items (i.e. Spoon,glass, pen, book, bottle, dish, wristwatch, ball, keys, comb, toothbrush) in the tray and ask participants to look and remember the items within a set time (1 minute), then cover these items with a cloth.
Participants will be asked to recall all items by placing the matched
pictures they recalled in front of them.
The interventionist will tally the correct number of recall items.
The interventionist will remove three items and ask the participants to place the pictures of the missing items.
The correct answers will be tallied again.
Rationale: the visual sense activities stimulates short-term memory, which is controlled by the occipital lobe, thalamus, and hypothalamus.
Session 2 Smell sense stimulation
Activity
Patients will be sitting comfortably, with their eyes closed, and participants will be asked to smell flowers within the time set. (1 minute)
Each participant smells four different scents -two flowers (jasmine & plumeria) - and two herbs ( cumin & mint ).
participants will be asked to guess each item and write it down on paper, with their non-dominant hand, within the time set (1 minute).
The correct answers will be tallied.
Rationale   this smell sense activity stimulates the olfactory nerve that directly connects to the cortex, hippocampus, and other parts of the limbic system involved in processing emotions and storing memories.
Session 3 Hearing sense stimulation
Activity 
Participants will be asked to close their eyes and listen attentively to three different nature sounds audio note. (Tidal waves, waterfall, birds singing) for 10 secs each.
Participants will be asked to guess each sound and write it down on paper within the time set (1 minute).• The participants will be asked to close their eyes again and listen to a combination of music while listening to several natural sounds (bell ring ,thundering, tidal wave, waterfall, birds singing) with closed eyes for 10secs.
Participants will be asked to identify each sound that they heard and write it down on paper within the time set (1 minute).
The correct answers will be tallied.
Rationale: This hearing sense activity stimulates the temporal lobe and limbic systems that store memories of emotion and motivation. Also, listening to music increases the neurotransmitter dopamine.
Session 4: Touch sense stimulation
Activity 
All participants will be divided into three groups (3-4 persons/group), and one member of the group will receive the words (five short words) from the interventionist.
The first participant from each group will read and remember the word.
They will use a finger to write the word on the back of the next person in the group, and the next person will do this until the last person.
The last person in the group will guess what the word was and write that word on paper within the time set. (1min).
Playing a puzzle box game, the participants will touch five items (spoon, glass, pen, book, bottle,) inside a box with their non-dominant hand,
while closing their eyes.
Participants will be asked to guess each item and write it down on paper
within the time set (1 minute). Upon completing the hearing and touch sense activities, the interventionist summarises how to use or apply hearing and touch sense stimulation in their daily life.
Rationale: the touch sense activity activates the frontal and parietal lobes. The frontal lobe is essential for cognitive functions and plays an important part in processing both short-term memories and the retention of longer-term memories.
Session 5 Taste sense stimulation
Activity 
With their eyes closed, participants will be asked to taste food items in several flavors: sweet (banana), sour (lemon), salty(salted peanuts) and bitter ( bittergourd) tastes.
Participants will be asked to guess each item and write it down on paper, with their non-dominant hand, within the time set (1 minute).
The participants will be asked to close their eyes again and taste food.(Biscuit , namkeen)
Participants will be asked to guess the names of food items and write it down on paper with their non-dominant hands.
For the food , they could mark the crosses on the answer sheet with their non-dominant hand. Upon completing the taste sense activities, the interventionist summarizes how to use or apply visual and smell stimulation in their daily life.
Rationale : the taste activity affects the ability to retrieve memories. Also, it stimulates the frontal lobe, which controls essential cognitive skills; such as emotional expression, problem-solving, memory, language and judgment.
Session 6  Integration of multi-senses.
Activity 
All participants will be divided into two groups to compete in a cooking Game.
Each group creates a menu, plans, and manages the time within the time set (10 minutes).
Each group cooks its menu within the time set (20 minutes).
Participants present their menu and summarize how to plan and manage the group.
Upon completing the last week of intervention, the interventionist answers any questions and summarizes how to use or apply neurobic exercise in their daily life.
Rationale   combining two or more senses involves processing short-term memories and retaining longer-term memories.
 
Close