| CTRI Number |
CTRI/2025/04/085462 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| 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
|
Efficacy of Binaural beats and motor training in improving Stress and anxiety and prevention of falls in older adults |
|
Scientific Title of Study
|
Efficacy of binaural auditory beats and motor training on stress, anxiety and the risk of falls in healthy older adults : A randomized 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 |
Shanika Sharma |
| Designation |
Assistant Professor, PhD scholar |
| Affiliation |
Lovely Professional University |
| Address |
School of Allied Medical Sciences, Department of Physiotherapy, Lovely Professional University, Phagwara
Kapurthala
PUNJAB
144411
India |
| Phone |
7018955885 |
| Fax |
|
| Email |
sharmashanika19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mebanpynjop Dohtdong |
| Designation |
MPT 2nd year (Neurology) |
| Affiliation |
Lovely Professional University |
| Address |
School of Allied Medical Sciences, Department of Physiotherapy, Lovely Professional University, Phagwara
Kapurthala
PUNJAB
144411
India |
| Phone |
9877347092 |
| Fax |
|
| Email |
pynjopmeban@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mebanpynjop Dohtdong |
| Designation |
MPT 2nd year (Neurology) |
| Affiliation |
Lovely Professional University |
| Address |
School of Allied Medical Sciences, Department of Physiotherapy, Lovely Professional University, Phagwara
Kapurthala
PUNJAB
144411
India |
| Phone |
9877347092 |
| Fax |
|
| Email |
pynjopmeban@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mebanpynjop Dohtdong |
| Address |
Department of Physiotherapy, school of allied Medical Sciences Lovely Professional University, Phagwara,144411 |
| Type of Sponsor |
Other [self] |
|
|
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 Mebanpynjop Dohtdong |
Lovely Professional University |
Room no. 105, LPU OPD, 3rd block, School of Allied Medical Sciences, Lovely Professional University,
Jalandhar-Delhi G.T.Road
Phagwara, Punjab(India)-144411
Kapurthala
PUNJAB |
9877347092
pynjopmeban@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Lovely Professional University (IEC-LPU) (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, (2) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Binaural beats |
Binaural Beats -The subjects will be fully instructed on how to listen to binaural beats, which includes using their own set earphones (if possible) and downloading a free app called Brain Wave from Google Play or the App Store. The individuals will be directed to a quiet room with no disturbances. They will be comfortably seated in a chair or laying on a couch. The subjects will be required to listen to alpha binaural beats at a comfortable volume for 30 minutes.
GROUP A: Participants of group A will be administered binaural beats along with motor training. Prior to commencement of study and actual data acquisition participants will be given one/two sessions to familiarize them with the procedure and exercises of the study. On first day of study baseline measurements will be obtained for BBS, TUG, DGI, DASS, Hamilton anxiety scale, perceived stress scale followed by administration of intervention (binaural beats along with motor training). The intervention will be given for once a day for 5 days a week and in total for 4 weeks. At the end of 4 weeks outcome measures will be recorded again. |
| Intervention |
Motor training
|
A certain sort of fitness program that includes task-specific training and strength training. In this study the participants will perform a range of exercises which include balance and coordination training in additional to strength training for both upper and lower limbs.
GROUP B: Participants of Group-B will also follow same procedure as by participants of group A, however group B participants will be administered only motor training.
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Individuals who are in the age group of 50-70 years
2 Individuals without any psychiatric diseases like bipolar disorder, Post Traumatic Stress Disorder (PTSD) and Schizophrenia.
3 Individuals with fear of falling
4 Individuals with symptoms of fear and anxiety
|
|
| ExclusionCriteria |
| Details |
1 Individuals with hearing impairments
2 Individuals with bone problems like osteoporosis and osteopenia.
3 Any neurological disorders like stroke or parkinsonism, spinal cord injury, epilepsy and seizures, multiple sclerosis.
4 Any cardiovascular disorders like heart failure, cardiomyopathy, arrhythmia etc.
5 Participants who are unwilling to pursue the research due to personal reasons.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DASS21, Berg Balance Scale, Dynamic Gait Index |
T1= Pre intervention week 0
T2= Post intervention week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perceived Stress Scale |
T1= Pre Intervention week 0
T2= Post intervention week 1 |
| Time up & go test |
T1= Pre intervention week 0
T2= Post intervention week 4 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
04/05/2025 |
| 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="20" |
|
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
|
The present study is a single-blinded, randomized clinical trial conducted with 40 participants aged 50-70 years across two centers in Shillong, Meghalaya. It proposes a unique intervention that combines motor training with binaural beats to investigate their combined effect on stress, anxiety, and the risk of falls in older adults. The subjects will be divided into an experimental group receiving both motor training and binaural beats, and a control group receiving only motor training. The motor training will be incorporated to improve balance, mobility, and overall reduction in the risk of falls, while the binaural beats application will be used to manage stress and anxiety. The intervention will be administered 5 days a week over a period of 4-week, with pre- and post-intervention assessments using established scales for balance (BBS), mobility (TUG, DGI), stress, and anxiety (DASS12, PSS). |