| CTRI Number |
CTRI/2024/01/061113 [Registered on: 04/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of balance exercises in addition to brain exercises on conscious brain functions in elderly with mild age related deficits in mental processes |
|
Scientific Title of Study
|
Effectiveness of vestibular therapy as an adjunct to cognitive therapy to improve cognition in elderly with mild cognitive impairment (MCI): A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Majumi M Noohu |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room number 105, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Majumi M Noohu |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room number 105, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Goswami |
| Designation |
MPT Student |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
7838550571 |
| Fax |
|
| Email |
abhishekg19999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg Jamia Nagar Okhla New Delhi - 110025 |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Maulana Mohammad Ali Jauhar Marg Jamia Nagar Okhla New Delhi - 110025 |
| Type of Sponsor |
Other [Central University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Majumi M Noohu |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
Room no. 8, Ground floor, OPD Centre for Physiotherapy and Rehabilitation Sciences clinic, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi - 110025
South
DELHI |
9868023378
mnoohu@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jamia Millia islamia |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F068||Other specified mental disorders due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cognitive therapy alone will be given |
Cognitive therapy will be given using computer based games training and the software for the games will be provided by Lumosity inc. By playing these games the participants practice tasks that require memory or recalling abilities attention spatial reasoning logical reasoning information processing and thus train these cognitive domains.
Route - Computer-based nonaction video game training
Frequency - 3 days a week for 8 weeks
Duration- 30 mins a day for 8 weeks
8 weeks protocol 3 days a week 30 minutes a day.
The games include
1. Assist ants to train divided attention the player directs ants to prevent their collision.
2. Fues clues to train logical reasoning the objective of Fuse clues is to place fuses in the correct order to restore power to apartments in a building. The order of the fuses is based on a numerical pattern you must solve to restore power.
3. Masterpiece to train spatial reasoning the player will have to fit pieces of mosaic together.
4. Familiar faces to train memory familiar Faces require recalling both the customers orders and their names.
5. Highway hazards to train speed of information processing the player quickly dodges obstacles in a race through the desert. This checks the ability to process and analyze incoming information.
The difficulties of the tasks will be increased in the subsequent weeks.
|
| Comparator Agent |
Participants will continue with their normal day to day activities and no specific intervention will be given |
The participants will continue with their activities of daily living and they will not be enrolled in any other exercise program. |
| Intervention |
Vestibular Therapy along with Cognitive Therapy |
Vestibular therapy along with Cognitive therapy for 8 weeks.
Vestibular therapy will be given according to Cawthrone and Cooksey protocol for vestibular rehabilitation which adds flexibility cognition sensory engagement and muscle strength components to the exercises.
8 weeks protocol 3 days a week 30-45 mins a day.
Route - head rotations and body Exercises
Frequency - 3 days a week for 8 weeks
Duration - 30-45 mins a day for 8 weeks
Exercises set 1 in the first week in a supine lying position
Eye and head exercises will be done. For example 1. Eye convergence exercises 2. Moving head backward and forward alternatively.
Exercises set 2 in the second week in a sitting position
In addition to the eye and head exercises mentioned above participants will be made to do shoulder exercises. For example 1. Shrugging and rotating shoulders 2. Throw and catch the ball from side to side while sitting.
Exercises set 3 in the 3rd 4th and 5th week in a standing position
In addition to the exercises mentioned above participants will be made to do exercises in a standing position. For example 1. Throwing a small ball from hand to hand under the knee 2. Changing from sitting to standing and turning around in between.
Exercises set 4 in the 6th 7th and 8th week in a walking position
In addition to the exercises mentioned above the participants will be made to do exercises in a walking position. For example 1. Throwing and catching the ball while walking in a circle and straight line 2. Walking across the room with eyes open and closed backward-forward sideways and turning head.
Cognitive therapy will be given using computer-based games training and the software for the games will be provided by Lumosity Inc. By playing these games the participants practice tasks that require memory or recalling abilities attention spatial reasoning logical reasoning information processing and thus train these cognitive domains. 8 weeks protocol 3 days a week 30 minutes a day.
The games include
1. Assist ants to train divided attention the player directs ants to prevent their collision.
2. Fues clues to train logical reasoning the objective of Fuse clues is to place fuses in the correct order to restore power to apartments in a building. The order of the fuses is based on a numerical pattern you must solve to restore power.
3. Masterpiece to train spatial reasoning the player will have to fit pieces of mosaic together.
4. Familiar faces to train memory familiar Faces require recalling both the customers orders and their names.
5. Highway hazards to train speed of information processing the player quickly dodges obstacles in a race through the desert This checks the ability to process and analyze incoming information
The difficulties of the tasks will be increased in the subsequent weeks
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Elderly aged 60 years and above
Both females and males
Subjects with basic knowledge of primary education
Subjects with mild cognitive impairment according to the ACE III scale with cut off score of 83 out
of 100 and or MMSE reference values according to education level: illiterate less than 13
elementary or middle less than 18 and high education less than 26 out of 3o.
Subjects with minimum to no risk of falls according to Short FES cut-off score of 7
out of 28
Subjects having no prior history of neurological diseases and falling which could
contribute to balance instability. |
|
| ExclusionCriteria |
| Details |
Subjects taking medications affecting consciousness or indirectly cognitive system,
Subjects with a history of other neurological conditions that may alter cognition,
Subjects with any significantly diagnosed visual and auditory impairment,
Presence of severe neurological disease or psychiatric illness such as mood disorders
depression or anxiety, bipolar disease, etc,
Non-cooperative subjects,
Subjects who are involved in other routine physical activities, and
Subjects with medical contraindications for making the necessary head movements during vestibular rehabilitation example Severe cervical disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Electroencephalogram to study brain waveforms in terms of spectrum and coherence that correspond to different cognitive functions including attention memory reasoning information processing.
2. P300 records an event-related potential and is used to analyze brain waveforms that correspond to attention memory and information processing.
3. Digit symbol substitution test measures a range of cognitive operations and requires intact motor speed attention and visuo-perceptual functions.
4. Digit symbol coding test WAIS-R is used to evaluate processing speed. It consists of 9 digit symbol pairs Under
each digit the subject has to write down the related symbol as quickly as possible in 90 seconds.
|
Baseline assessment at 1st week before the commencement of trial.
At 8th week Post-intervention assessment.
At 10th week from the baseline follow up assessment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The Stroop test assesses selective attention and inhibition.
2. Trail making tests TMT-A and TMT-B used to assess executive function and attentional abilities. Part A of TMT evaluates the information processing speed, while part B assesses cognitive flexibility or switching. In part A, the task consisted in connecting numbers (from 1 to 25) with straight lines as fast as
possible. In part B, participants had to alternate between letters in alphabetical order and
numbers in ascending order 1-A-2-B-3C, etc. as fast as possible.
3. European Quality 5 Dimensions EQ-5D is a widely used generic HRQOL
instrument and assesses a respondents health status on the day of the survey in five dimensions mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. |
Baseline assessment at 1st week before the commencement of trial.
At 8th week Post-intervention assessment.
At 10th week from the baseline follow up assessment.
|
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
10/01/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Background and Aim - Considering
the critical input of the vestibular system to the hippocampus as an area
involved in cognition, we aim to investigate the effectiveness of vestibular
therapy as an adjunct to cognitive therapy to improve cognition in elderly with
mild cognitive impairment.
Methodology - It will be a
prospective randomized controlled trial, including the elderly (60 years of age
and above, both males and females, and have a primary level of education). The
participants will be screened for mild cognitive impairment using the
Addenbrooke Cognitive Examination – III scale and Mini-mental examination
scale. A short-falls efficacy scale will be used to determine a minimum to no
risk for falls. 36 patients with mild cognitive impairment will be randomly
assigned to three groups receiving 1. Group
1 – Vestibular therapy along with cognitive therapy, 2. Group 2 – cognitive
therapy alone, 3. Group 3 – No specific intervention will be given to the
patients and they will be asked to continue with their activities of daily
living during the study duration.
Results - will be reported for
all the outcome measures at baseline, post-intervention at the 8th week from
baseline, and at the 10th week from baseline. Statistical analysis
using SPSS software for Anova with repeated measures will be done to find
within and between the group interactions with post hoc analysis. |